Amit, Ido; Baker, David; Barker, Roger;
What will be the most important areas of research in biotech over the coming years? Which technologies will be most important to advance knowledge and applications in these areas? Nature Biotechnology reached out to a set of investigators working in research areas representative of the journal...
groups. In this, the paper tries to make up for the limited focus upon the role played by metaphor and discourse in shaping public attitudes of biotechnology. The paper has two parts; a theoretical part discussing the combination of conceptual metaphor studies and critical discourse analysis to provide......In Denmark, as in many other European countries, biotechnology continues to be a much debated and controversial issue. The paper takes its starting point in this debate, investigating how metaphorical constructions in media discourse reproduce and promote the viewpoints of particular societal...... a more comprehensive frame for explaining the function of metaphor in use, and an empirical part analysing biotech-metaphors in the Danish print press. Although not conclusive, the analysis points to metaphorical constructions in the press being both grounded in basic image schematic structures...
In April 2004, Copenhagen Business School opens a centre for research on biotech business. Biotech Business includes a number of senior and junior researchers from CBS. Initially the centre takes its point of departure in four projects included in the research program on Competence, Organisation...... and Management in Biotech Industries (COMBI). Starting in March 2004, COMBI is funded jointly by The Danish Social Research Council, firms and organisations in the Danish biotech industry and CBS. This presentation refers exclusively to four COMBI projects....
Ruffing, Anne [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)
The objective of this project is to modify the FluorAbody plasmid previously developed by Sandia Biotech to include a binding site for biotin by introducing the biotin carboxyl carrier protein (BCCP)and a gold binding protein (GBP) into a loop of the red fluorescent protein (mRFP).
Smith-Doerr, L.; Kemekliene, G.; Teutonico, R.;
Increasing women's participation in leadership of biotech policy making, funding, research and implementation will strengthen the race to solve global problems......Increasing women's participation in leadership of biotech policy making, funding, research and implementation will strengthen the race to solve global problems...
Hopkins, Michael M.; Crane, Philippa A; Nightingale, Paul; Baden-Fuller, Charles
This article explores how the UK's biotech firms have evolved in response to their financial environment. As investors' expectations about the potential of biotech have changed, funding options have opened up and closed down, leading firms to develop new business models and routes of technology development. After a favorable period, new constraints on stock market funding have forced UK biotech firms to compress their life cycles, constraining their ability to generate the late-stage drug can...
Rathore, Anurag S; Bhushan, Nitish; Hadpe, Sandip
Biotech unit operations are often characterized by a large number of inputs (operational parameters) and outputs (performance parameters) along with complex correlations amongst them. A typical biotech process starts with the vial of the cell bank, ends with the final product, and has anywhere from 15 to 30 such unit operations in series. The aforementioned parameters can impact process performance and product quality and also interact amongst each other. Chemometrics presents one effective approach to gather process understanding from such complex data sets. The increasing use of chemometrics is fuelled by the gradual acceptance of quality by design and process analytical technology amongst the regulators and the biotech industry, which require enhanced process and product understanding. In this article, we review the topic of chemometrics applications in biotech processes with a special focus on recent major developments. Case studies have been used to highlight some of the significant applications.
Lund Jensen, Rasmus; Dahlgren, Henrich; Valentin, Finn
This report studies employment effects associated with the adoption of modern biotechnology in Danish industry. In this context we also examine industry structure, patterns of job creation, key outputs such as patents and the pipeline of projects in clinical trials. To see the development of Danish biotech firms in a relevant context we compare a Danish segment of biotech firms with a matching Swedish segment. From an overall assessment modern biotechnology, despite the three decades elap...
Biotechnology companies face ethical challenges of two distinct types: bioethical challenges faced on account of the nature of work in the life sciences, and corporate ethical challenges on account of their nature as commercial entities. The latter set of challenges has received almost no attention at all in the academic literature or media. This paper begins to remedy that lacuna, examining ethical issues that arise specifically on account of the status of biotech companies as commercial entities. The focus here is on three representative issues: product safety, corporate social responsibility, and corporate governance. It is argued that each of these issues poses particular ethical challenges for companies in the biotech sector. In the area of product safety, it is noted that biotech companies face particular challenges in determining what counts as a "safe" product, given the contentious nature of what might count as a "harm" in the biotech field. In the area of corporate social responsibility, the adoption of a "stakeholder approach" and an attempt to manage the social consequences of products pose special challenges for biotech companies. This is due to the enormous range of groups and individuals claiming to have a stake in the doings of such companies, and the trenchant controversies over just what the social consequences of various biotechnologies might be. In the area of corporate governance, biotech companies need to seek out and follow best practices regarding the ways in which information, authority, and influence flow between a company's shareholders, managers, and Board of Directors, if they are to avoid duplicating the ethical and financial scandal that brought down ImClone. An important meta-issue, here--one that renders each of these corporate ethical challenges more vexing--is the difficulty of finding the appropriate benchmarks for ethical corporate behavior in a field as controversial, and as rapidly evolving, as biotechnology. Three
Valentin, Finn; Dahlgren, Johan Henrich; Lund Jensen, Rasmus
This report studies employment effects associated with the adoption of modern biotechnology in Danish industry. In this context we also examine industry structure, patterns of job creation, key outputs such as patents and the pipeline of projects in clinical trials. To see the development of Danish...... tools and approaches into an operational, reliable, cost-effective technology, sufficiently `pluggable' with other technologies. Therefore employment directly related to biotech is particularly visible and identifiable in firms focused on R&D. Outside this core of R&D activity other industries appear...... a segment of Drug Discovery Firms (DDFs), which almost exclusively are based on capabilities in biotech research. This delimitation gives the advantage of studying a homogenous segment of firms. At the same time, this segment of biotech research firms is an informative indicator of the ability of the Danish...
Chakraborty, Shamik; Bodhinayake, Imithri; Chiluwal, Amrit; Langer, David J; Ruggieri, Rosamaria; Symons, Marc; Boockvar, John A
The Brain Tumor Biotech Center at the Feinstein Institute for Medical Research, in collaboration with Voices Against Brain Cancer hosted The Brain Tumor Biotech Summit at in New York City in June 2015. The focus was once again on fostering collaboration between neuro-oncologist, neurosurgeons, scientists, leaders from biotechnology and pharmaceutical industries, and members of the financial community. The summit highlighted the recent advances in the treatment of brain tumor, and specifically focused on targeting of stem cells and EGFR, use of prophage and immunostimulatory vaccines, retroviral vectors for drug delivery, biologic prodrug, Cesium brachytherapy, and use of electric field to disrupt tumor cell proliferation. This article summarizes the current progress in brain tumor research as presented at 2015 The Brain Tumor Biotech Summit.
Gruber, Alexandra C
Based on a qualitative study analyzing a series of interviews with dedicated biotech entrepreneurs and high-level investors, "Biotech Funding Trends" provides a comprehensive overview of current trends in biotech funding by taking a close look behind the scenes of the biotech industry. In particular, it illustrates the tensions between both key players based on their different backgrounds and expectations. Here we outline the various funding opportunities for the biotech industry in Europe and identify ways for both sides, entrepreneurs and investors to overcome their prejudices to successfully thrive in a competitive environment. The results are also discussed in the light of the current financial and economic crisis.
Ruel, H.J.M.; Frolova, P.; Groen, A.J.
This paper presents a study on the determinants of entrepreneurial culture in innovative biotech clusters. A literature review led to the identification of nine determinants. For the empirical study four clusters in Western Europe with a high entrepreneurial culture were selected. Cluster participan
; Hyland 1998). This point is arguably of more importance to a biotech company which in its communication to the public may have to consider promoting an overly favourable and trustworthy image not only of its financial results, but also of the industry in which it is engaged, to ensure continuous......In Denmark, biotechnology and its physical product, the genetically modified organism, continues to be controversial, leading to widespread public scepticism. This paper explores the effect of such scepticism on part of the financial communication of one of Denmark's largest biotech companies......, Novozymes. Research indicates that besides accommodating a legal demand for the disclosure of company financial details, the annual report, in particular the letter to the shareholders or the CEO's letter, serves the purpose of marketing the company to its constituents (Bowman 1984; Bülow-Møller 2003...
Cuban advances in biotech have made headlines, particularly since the US-Cuba rapprochement and signing of the historic memorandum of understanding between the US Department of Health and Human Services and Cuba's Ministry of Public Health in June. Some 34 Cuban institutions with 22,000 employees are the backbone of a biotech industry that dates to the early 1980s, obtaining novel products that have sparked interest among potential global partners. While a number of these Cuban products are registered in various countries, their testing in the USA remains ensnared in the red tape of embargo laws that tend to make investors skittish and thus delay, if not curtail, joint research and clinical trial applications to the FDA.
Modern biotechnology became possible because of the ability to clone genes and produce gene products barriers of species and sex. Potential entrepreneurs are getting interested in venturing into health care biotech industry, stimulated by the success story in information technology. Products of protein therapeutics, such as insulin, growth hormones, interferons, blood proteins, streptokinase and vaccines have received special attention. Pharmaceutical companies got into the field of d...
Schimmer, Joshua; Breazzano, Steven; Yang, Jerry
After a few torrid years of value appreciation, the biotech "bubble" has precipitously popped over the past few months. In this report, we take a look at some of the factors that drove the run-up in valuations, the triggers that led to their substantial pullback, and where the industry may be headed from here. Gene therapy/editing companies have been particularly affected by these dynamics, raising a new set of questions and challenges for the group.
The Chinese Medical Biotech Association's Fourth Medical Biotech Forum held in Dalian, China included topics covering the biotechnology industry in China and new therapeutic developments in the field of immunological approaches to cancer treatment. This conference report highlights selected presentations on China's biotechnology development policy, tumor-specific antigens, clinical applications of antitumor immune therapy, and novel photodynamic tumor therapy. Investigational therapeutics discussed include astuprotimut-r (GlaxoSmithKline plc) and the dendritic cell vaccine Trivax (Trimed Biotech).
Biotechnology is a life science-based technique especially used in agriculture, medicine and food sciences. It is generally defined as the manipulation in organisms to generate products for the welfare of the world. Biotechnology combines disciplines such as genetics, biochemistry, microbiology, and cell biology along with information technology, chemical engineering, robotics etc. It includes basic industries such as food processing, tissue culture, plant development and other sophisticated ones such as recombinant therapeutics and diagnostics. Biotechnology, globally recognized as a rapidly emerging and far-reaching technology, is aptly described as the "technology of hope" for its promise of food, health and environmental sustainability. In India, biotechnology employs more than 10 000 people and generates roughly US$ 500 million in revenue annually. The biotechnology market has increased its sales from Rs. 50 billion in 1997 to Rs.70 billion in 2000, and is expected to cross Rs. 240 billion by the year 2010. In India, the human health biotech products account for 60% of the total market; agribiotech and veterinary 25%, medical devices, contract research and development (R&D), reagents and supplies constitute the remaining 15% Moreover, to facilitate foreign investment, capital and government policies are being revised. Other important industries include industrial enzyme manufacture, bioinformatics, and medical devices. Biotechnology has had limited appeal so far on our capital markets, and we have less then a dozen biotech companies listed on the public markets.
Golec, Joseph; Vernon, John A
The biotech industry now accounts for a substantial and growing proportion of total R&D spending on new medicines. However, compared with the pharmaceutical industry, the biotech industry is financially fragile. This article illustrates the financial fragility of the biotech and pharmaceutical industries in the US and the implications of this fragility for the effects that government regulation could have on biotech firms. Graphical analysis and statistical tests were used to show how the biotech industry differs from the pharmaceutical industry. The two industries' characteristics were measured and compared, along with various measures of firms' financial risk and sensitivity to government regulation. Data from firms' financial statements provided accounting-based measures and firms' stock returns applied to a multifactor asset pricing model provided financial market measures. The biotech industry was by far the most research-intensive industry in the US, averaging 38% R&D intensity (ratio of R&D spending to total firm assets) over the past 25 years, compared with an average of 25% for the pharmaceutical industry and 3% for all other industries. Biotech firms exhibited lower and more volatile profits and higher market-related and size-related risk, and they suffered more negative stock returns in response to threatened government price regulation. Biotech firms' financial risks increase their costs of capital and make them more sensitive to government regulations that affect their financial prospects. As biotech products grow to represent a larger share of new medicines, general stock market conditions and government regulations could have a greater impact on the level of innovation of new medicines.
Full Text Available Modern biotechnology became possible because of the ability to clone genes and produce gene products barriers of species and sex. Potential entrepreneurs are getting interested in venturing into health care biotech industry, stimulated by the success story in information technology. Products of protein therapeutics, such as insulin, growth hormones, interferons, blood proteins, streptokinase and vaccines have received special attention. Pharmaceutical companies got into the field of diagnostics, a major thrust area being products of antigen/antibody and nucleic acid-based diagnostic kits. The ability to clone and sequence genes from a variety of organisms has culminated in the subject of genomics. High throughput screening of thousands of organic molecules against a battery of drug targets using robotic machinery is the current approach to come up with lead molecules. New drug delivery systems for slow, sustained and direct delivery to target tissues are under way. There is hope that hereditary and metabolic disorders may have a cure through replacements of defective genes by normal cloned genes and by blocking the expression of unwanted genes, respectively. This mega approach would call for the availability of DNA chips, a product of collaboration between molecular biologists and electronic engineers. The tendency now-a-days is for a marriage between biotech and pharmaceutical industries. Animal cloning, spearheaded by the birth of Dolly, has revolutionised cell biology and is of promise to generate animal bio-vectors to produce desired protein pharmaceuticals in milk. Stem cell research has assumed a lot of importance. In our country, reasonable competence has been built-up in the field of biotechnology. Around two dozen institutes carry out front-line research in medical biotechnology. Successful commercialisation of a few diagnostic kits and recombinant vaccines has provided an impetus and enthusiasm to exploit biotechnology in a big way
... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Advanced Growing Systems, Inc., Advantage Capital Development Corp., Amazon Biotech, Inc., Andover... of current and accurate information concerning the securities of Amazon ] Biotech, Inc. because...
East, Kelly M; Hott, Adam M; Callanan, Nancy P; Lamb, Neil E
Recent advances in research and biotechnology are making genetics and genomics increasingly relevant to the lives and health of the general public. For the public to make informed healthcare and public policy decisions relating to genetic information, there is a need for increased genetic literacy. Biotech 101 is a free, short-course for the local community introducing participants to topics in genetics, genomics, and biotechnology, created at the HudsonAlpha Institute for Biotechnology. This study evaluated the effectiveness of Biotech 101 in increasing the genetic literacy of program participants through pre-and-post surveys. Genetic literacy was measured through increases in self-perceived knowledge for each content area covered through the course and the self-reported impact the course had on various aspects of participants' lives. Three hundred ninety-two individuals attended Biotech 101 during the first three course offerings. Participants reported a significant increase in self-perceived knowledge for each content area (p biotechnology.
More than 160 experts from industry and academia came together this September for the Biotech 2011 at the Zurich University of Applied Sciences (ZHAW) in Wädenswil. As one of the main topics, the conference addressed innovations in sensor technology, where new measurement principles and methods have helped to enhance robustness and user friendliness. Another main emphasis of Biotech 2011 was the application of sensors and related analytical techniques in bioprocesses. In this area, the sensor industry needs to meet the challenges introduced by the increasing use of single-use bioreactors. With its strong focus on sensor applications, Biotech 2011 successfully promoted interaction between professionals in academic and industrial research as well as with experts who apply sensors in biopharmaceutical production.
Vogenberg, F Randy; Young, Coleen
Biotechnology-derived injectable medications raise complex issues with respect to access and administration for both manufacturers and payers. In addition, biotech injectables rarely fit within traditional prescription drug benefit design structures, thereby creating inequities in reimbursement and access that can undermine a health benefit plan's goals.Benefit-design changes focusing on short-term solutions can exacerbate such situations. Employers, insurers, and managed care organizations need to consider innovative benefit-plan designs to effectively address issues that are associated with biotech medications.Actuarial models, such as the Reimbursement model described in this article, can help to provide the options analyses and decision-making support that are required.
López Silva, Christian
Amid the epidemiological transition that Mexico is currently experiencing, an adequate access to biotech medicines is becoming very important. However, these medicines also involve new challenges for the sanitary authorities, given their higher complexity in structure and function than conventional chemical drugs. Consequently, it has been necessary to update the Mexican legal framework, which has placed Mexico at the forefront in this sector. This article describes briefly what biotech drugs are, why it has been necessary to regulate them differently, the evolution of the regulatory framework in Mexico, and the general features of the new system.
... issues and biotechnology to discuss industry developments, opportunities, and sales strategies... consumer base and impressive economic growth further reinforce the importance of the market for U.S. firms... trials in Asia. The Biotech Life Science Sector Despite the global financial crisis, China's GDP...
Boschma, Ron; Heimeriks, Gaston; Balland, Pierre-Alexandre
This paper investigates the impact of scientific relatedness on knowledge dynamics in biotech at the city level during the period 1989-2008. We assess the extent to which the emergence of new research topics and the disappearance of existing topics in cities are dependent on their degree of scientif
Glazer, Richard B.
Describes Project Biotech, a program that utilizes the audio-tutorial principle to develop skill-oriented modules. The modules are self-pacing, independent units of instruction which concentrate on a few well-defined objectives and allow the student to learn at his own rate with minimal supervision. (PB)
Dawabi, Peter; Wessner, Martin
The background of this paper is an internal research project at the German National Research Center for Information Technology, Integrated Publication and Information Systems Institute, (GMD-IPSI) dealing with software engineering, computer-supported cooperative learning (CSCL) and practical biotech knowledge. The project goal is to develop a…
Murphy, Amanda; Stramiello, Michael; Stroud, Jonathan; Lewis, Stacy; Irving, Tom
This review introduces the America Invents Act (AIA), a comprehensive reform of U.S. law on patentability and patent enforceability that Congress enacted in 2011. The AIA's most publicized change transforms the United States from a "first-to-invent" system to a "first-inventor-to-file" regime, bringing U.S. patent law more in line with the patent systems of nearly every other industrialized country in the world. This new system requires small companies and independent inventors to toe the line against larger competitors in what many have called a "race to the patent office." But a closer look at the AIA reveals several opportunities for smaller entities that may even the playing field, particularly for innovators in the biotech sector. This article addresses changes that the AIA brings to U.S. patent law, keeping an eye toward issues relevant to biotech companies.
Ottenhausen, Malte; Bodhinayake, Imithri; Banu, Matei; Kesavabhotla, Kartik; Ray, Ashley; Boockvar, John A
For the second time, The Brain Tumor Center of the Weill Cornell Brain and Spine Center, in collaboration with Voices Against Brain Cancer, hosted The Brain Tumor Biotech Summit in New York City in June 2013. After a very successful first summit in 2012, this innovative event has established a platform for intensive networking between neuro-oncologists, neurosurgeons, neuroscientists, members of the biotechnology and pharmaceutical communities, members of the financial community and leaders of non-profit organizations. This year's summit highlighted dendritic cell vaccines, novel antibody, heat shock protein and targeted therapies as well as exosome technologies, MRI-guided therapies and other novel drug delivery tools. This report presents a short overview of the current progress in brain tumor research and therapy as presented at the 2013 Brain Tumor Biotech Summit.
Patents on biotech products have a scope that goes well beyond what is covered by the most widely applied ethical justifications of intellectual property. Neither natural rights theory from Locke, nor public interest theory of IP rights justifies the wide scope of legal protection. The article takes human genes as an example, focusing on the component that is not invented but persists as unaltered gene information even in the synthetically produced complementary DNA, the cDNA. It is argued that patent on cDNA holds this information captive, or illegitimately appropriates it in limiting other researchers and inventors' opportunity to explore new functions and uses based on this non-invented information. A tighter connection between legal IP protection and the use description stated in the patent claim is suggested. By binding protection to the product's foreseeable functions and use, instead of the product itself and all future uses of it, legitimacy of biotech product patents is restored.
Since 1998, the biotechnet--the national network of competence in biotech research--has been helping partners from industry to access excellence in R&D, giving them optimal support at low cost. Its annual 'Olten Meeting' is a dynamic hub for companies and research institutes as it highlights the latest trends in biotech. On November 24, 2010, the topical subject was biotech in medicine.
Lin, Jiunn H
With the advances in recombinant DNA biotechnology, molecular biology and immunology, the number of biotech drugs, including peptides, proteins and monoclonal antibodies, available for clinical use has dramatically increased in recent years. Although pharmacokinetic principles are equally applicable to the large molecule drugs and conventional small molecule drugs, the underlying mechanisms for the processes of absorption, distribution, metabolism and excretion (ADME) of large molecule drugs are often very different from that of small molecule drugs. Therefore, a good understanding of the ADME processes of large molecule drugs is essential in support of the development of therapeutic biologics. The purpose of this article is to review the current knowledge of the ADME processes that govern the pharmacokinetics of biotech drugs. The challenges encountered by orally administered peptide and protein drugs, and the nature of lymphatic absorption after subcutaneous administration will be discussed. In addition, molecular mechanisms of biodistribution, metabolism and renal excretion of biotech drugs will also be discussed. Finally, approaches used for prediction of human pharmacokinetics of protein drugs will be briefly discussed.
Haber, Jessica S; Banu, Matei A; Ray, Ashley; Kesavabhotla, Kartik; Boockvar, John A
With steadily rising revenue and large numbers of clinical trials utilizing novel treatment strategies, the field of neuro-oncology is at the core of the growing cancer therapy industry. In June 2012, the Weill Cornell Brain and Tumor Center hosted the first Brain Tumor Biotech Summit as a forum for fostering and encouraging collaboration between researches and investors to accelerate novel treatments for brain cancer. This event brought together neuro-oncologists, neurosurgeons, academicians, entrepreneurs, non-profits, CEOs and investors in an attempt to bring innovative treatments and concepts to the fore. Specific subjects presented at the meeting included new surgical devices and delivery techniques, targeted therapeutics, immunotherapy, and stem cell biology. The mission of the summit was to provide opportunities for researchers in neuro-oncology to directly interact with leaders from the investment community with insight into the commercial aspects of our work. Our shared goal is to shorten the time for basic science ideas to be translated into the clinical setting. The following serves as a progress report on the biotech industry in neuro-oncology, as presented at the Brain Tumor Biotech Summit.
van Egeraat, Chris; Curran, Declan
This paper presents an analysis of the socio-spatial structures of innovation, collaboration and knowledge flow among SMEs in the Irish biotech sector. The study applies social network analysis to determine the structure of networks of company directors and inventors in the biotech sector. In addition, the article discusses the implications of the findings for the role and contours of a biotech digital ecosystem. To distil these lessons, the research team organised a seminar which was attended by representatives of biotech actors and experts.
German Biotech-Companies and their Innovativeness in International Comparison – an Institutionalist Analysis 1 Introduction In the mid-1990s, legal changes and policy initiatives in Germany led to the rapid emergence of a biotechnology industry. Initially, German biotech companies focused on the mar
Heimeriks, G.J.; Boschma, R.
This study explores the worldwide spatial evolution of scientific knowledge production in biotechnology in the period 1986–2008. We employ new methodology that identifies new key topics in biotech on the basis of frequent use of title worlds in major biotech journals as an indication of new cognitiv
Heimeriks, Gaston; Boschma, Ron
This study explores the worldwide spatial evolution of scientific knowledge production in biotechnology in the period 1986-2008. We employ new methodology that identifies new key topics in biotech on the basis of frequent use of title worlds in major biotech journals as an indication of new cognitiv
... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION BIOTECH Holdings Ltd., California Oil & Gas Corp., Central Minera Corp., Chemokine Therapeutics... concerning the securities of BIOTECH Holdings Ltd. because it has not filed any annual reports since...
Moretti, Enrico; Wilson, Daniel J.
We evaluate the effects of state-provided financial incentives for biotech companies, which are part of a growing trend of placed-based policies designed to spur innovation clusters. We estimate that the adoption of subsidies for biotech employers by a state raises the number of star biotech scientists in that state by about 15 percent over a…
In the early 1990s, some were skeptical that genetically modified (GM) crops, now referred to as biotech crops, could deliver improved products and make an impact at the farm level. There was even more skepticism that developing countries would adopt biotech crops. The adoption of and commercialization of biotech crops in 2008 is reviewed. The impact of biotech crops are summarized including their contribution to: global food, feed and fiber security; a safer environment; a more sustainable agriculture; and the alleviation of poverty, and hunger in the developing countries of the world. Future prospects are discussed. Notably, Egypt planted Bt maize for the first time in 2008 thereby becoming the first country in the Arab world to commercialize biotech crops.
Bhushan, Nitish; Hadpe, Sandip; Rathore, Anurag S
A typical biotech process starts with the vial of the cell bank, ends with the final product and has anywhere from 15 to 30 unit operations in series. The total number of process variables (input and output parameters) and other variables (raw materials) can add up to several hundred variables. As the manufacturing process is widely accepted to have significant impact on the quality of the product, the regulatory agencies require an assessment of process comparability across different phases of manufacturing (Phase I vs. Phase II vs. Phase III vs. Commercial) as well as other key activities during product commercialization (process scale-up, technology transfer, and process improvement). However, assessing comparability for a process with such a large number of variables is nontrivial and often companies resort to qualitative comparisons. In this article, we present a quantitative approach for assessing process comparability via use of chemometrics. To our knowledge this is the first time that such an approach has been published for biotech processing. The approach has been applied to an industrial case study involving evaluation of two processes that are being used for commercial manufacturing of a major biosimilar product. It has been demonstrated that the proposed approach is able to successfully identify the unit operations in the two processes that are operating differently. We expect this approach, which can also be applied toward assessing product comparability, to be of great use to both the regulators and the industry which otherwise struggle to assess comparability.
Pisano, Gary P
In 1976, Genentech, the first biotechnology company, was founded by a young venture capitalist and a university professor to exploit recombinant DNA technology. Thirty years and more than 300 billion dollars in investments later, only a handful of biotech firms have matched Genentech's success or even shown a profit. No avalanche of new drugs has hit the market, and the long-awaited breakthrough in R&D productivity has yet to materialize. This disappointing performance raises a question: Can organizations motivated by the need to make profits and please shareholders successfully conduct basic scientific research as a core activity? The question has largely been ignored, despite intense debate over whether business's invasion of basic science-long the domain of universities and nonprofit research institutions- is limiting access to discoveries, thereby slowing advances in science. Biotech has not lived up to its promise, says the author, because its anatomy, which has worked well in other high-tech sectors, can't handle the fundamental challenges facing drug R&D: profound, persistent uncertainty and high risks rooted in the limited knowledge of human biology; the need for the diverse disciplines involved in drug discovery to work together in an integrated fashion; and barriers to learning, including tacit knowledge and murky intellectual property rights, which can slow the pace of scientific advance. A more suitable anatomy would include increased vertical integration; a smaller number of closer, longer collaborations; an emphasis by universities on sharing rather than patenting scientific discoveries; more cross-disciplinary academic research; and more federal and private funding for translational research, which bridges basic and applied science. With such modifications, science can be a business.
David; Brough; 柯善雪
夜读此文,既兴奋,又悲凉。兴奋,是因为千百年来,人们靠天吃饭,地里的活,种瓜得瓜,种豆得豆。得多少,并非“大跃进”可以吹出来的,而是有一个常规,种地能手,能超出常规亩产20％,已有登天之难。而如今,植物的遗传工程(genetic engineering of plants)令世人一惊:It can improve crop yields and develop resis-tance to drought(干旱),salinity(盐份)and pests(害虫)。Biotechnology is also used todevelop drugs to treat diseases such as diabetes and hepatitis(肝炎);悲凉的是,这些专利正紧锁于富国的保险柜中待价而沽:The big biotech companies are locking uppatents at an incredible(难以置信的)rate！其另一个借口是:The full impact of thesenew life sciences on health and the environment is not known。 本文末尾的一句话又让我们另有想法: Biotechnology is by no means the only answer to the problem of hunger as the words already producing more food than it needs。】
@@ 2008 was a year marked with changes and turns for biotech industry in China. 2008 began with tremendous promises riding on the waves of a history-making, exceptionally strong year in 2007. However, the biotech industry in China was not immune to the macroeconomic changes during 2008. This report will attempt to examine changes and new trends in biotech industry in China.
Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A
With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.
Lee, Seong-Hun; Kim, Jin-Kug; Yi, Bu-Young
Plants derived through agricultural biotechnology, or genetically modified organisms (GMOs), may affect human health and ecological environment. A living GMO is also called a living modified organism (LMO). Biotech cotton is a GMO in food or feed and also an LMO in the environment. Recently, two varieties of biotech cotton, MON 15985 and MON 88913, were developed by Monsanto Co. The detection method is an essential element for the GMO labeling system or LMO management of biotech plants. In this paper, two primer pairs and probes were designed for specific amplification of 116 and 120 bp PCR products from MON 15985 and MON 88913, respectively, with no amplification from any other biotech cotton. Limits of detection of the qualitative method were all 0.05% for MON 15985 and MON 88913. The quantitative method was developed using a TaqMan real-time PCR. A synthetic plasmid, as a reference molecule, was constructed from a taxon-specific DNA sequence of cotton and two construct-specific DNA sequences of MON 15985 and MON 88913. The quantitative method was validated using six samples that contained levels of biotech cotton mixed with conventional cotton ranging from 0.1 to 10.0%. As a result, the biases from the true value and the relative deviations were all within the range of +/-20%. Limits of quantitation of the quantitative method were all 0.1%. Consequently, it is reported that the proposed detection methods were applicable for qualitative and quantitative analyses for biotech cotton MON 15985 and MON 88913.
Mitze, Timo; Strotebeck, Falk
We analyse the determinants of network formation in Germany’s biotechnology industry using social network analysis combined with a regression approach for count data. Outcome variable of interest is the degree centrality of German regions, which is specified as a function of the region’s innovative...... and economic performance as well as biotech-related policy variables. The inclusion of the latter allows us to shed new light on the question to what extent R&D-based cluster policies are able to impact on the formation of the German biotech network. Our results show that policy indicators such as the volume...
Commercialization of Biotech crops started in 1995. By 2011, genetically modified (GM) crops were grown world-wide on 160 million ha. Only 114.507 ha of GM crops were grown in Europe, of that, 114.490 ha were Bt maize and 17 ha were potato for industrial starch production. Currently, developing c...
Minssen, Timo; Nilsson, David
at the date of filing to demonstrate a credible – or to use the terminology of the EPO – a plausible industrial application. In the final section of the article we shall also discuss various policy considerations relevant for the biotech industry and briefly refer to corresponding developments in the US...
This paper explores corporate social responsibility (CSR) in the biotech high-tech sector as a way to achieve competitive advantages. After presenting the importance of science for high-tech firms, the paper focuses on the social and economic role of CSR. Next, the primary reasons for firms' engagement in CSR activities are presented, followed by…
This paper explores corporate social responsibility (CSR) in the biotech high-tech sector as a way to achieve competitive advantages. After presenting the importance of science for high-tech firms, the paper focuses on the social and economic role of CSR. Next, the primary reasons for firms' engagement in CSR activities are presented,…
... publishing this supplement to the Notice of the Biotech Life Science Trade Mission to China, 76 FR 17,621..., 76 FR 17621, Mar. 30, 2011, are revised to read October 14-18, 2011. In addition, revise the Proposed... Trade Mission to China, 76 FR 17,621, Mar. 30, 2011, is amended to read as follows: Timeframe...
Herwig, Christoph; Garcia-Aponte, Oscar F; Golabgir, Aydin; Rathore, Anurag S
In the quality by design (QbD) paradigm, global regulatory agencies have introduced the concepts of quality risk management and knowledge management (KM) as enablers for an enhanced pharmaceutical quality system. Although the concept of quality risk management has been well elucidated in the literature, the topic of KM has received relatively scant attention. In this paper we present an opinion on KM in the QbD paradigm as it relates to the manufacturing of biotech therapeutic products. Both academic and industrial viewpoints have been considered and key gaps have been elucidated. The authors conclude that there is an urgent need for the biotech industry to create efficient KM approaches if they wish to be successful in QbD implementation.
Biotech firms always pursue broad claims to secure new discoveries, new technologies and even as yet undiscovered results of future research. However, expansive claims without sufficient description violate the principal of granting the patentee the right to exclude others from using the technical development for a certain amount of time in return for disclosing the innovation. Based on this investigation, a written description can be a barrier to biotech patents with broad claims. To avoid a written description rejection during patent prosecution or invalidation in litigation, the patent applicant or assignee should demonstrate possession of the claimed invention by describing the claimed invention with all of its limitations using descriptive means such as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Although the court cases analyzed in this study were not directly related to vaccines, the guideline indeed is applicable to patents of vaccine. Furthermore, a vaccine patent application is also demonstrated.
Chakraborty, Chiranjib; Agoramoorthy, Govindasamy
India's biotechnology industry has been growing towards new heights in conjunction with the recent economic outburst. The country has the potential to revolutionize biopharmaceutical and healthcare sectors. In this review, we have highlighted the achievements of India's biotechnology industry, especially biopharmaceutical and healthcare sectors that include therapeutics, diagnostics, stem cell research, human healthcare related bioinformatics and animal health care. We have also described regulatory mechanisms involved in India's health care biotech including manpower development.
Background: The companies involved for the purpose of improving their respective market standings and income executes mergers. It is interesting how this merger & acquisition phenomena continue to attract many organizations across different sectors of the business world. The mergers & acquisition culture around the globe provides an ideal scenario to investigate into the healthcare industry which comprises of pharmaceutical and biotech companies and the impact of the mergers on the firms inv...
The Swiss biotech landscape seems to be on a healthy footing: There are many imaginative start-ups, we have first-class hospitals, highly advanced clinical research and the availability of a great deal of capital. But we have no reason to rest on our laurels as countries like the USA lead the field. We must lay down the tracks today to remain an attractive country and maintain our ranking among the 10 best locations.
Lee, Seong-Hun; Kim, Su-Jeong; Yi, Bu-Young
Analytical methods are very important in the control of genetically modified organism (GMO) labeling systems or living modified organism (LMO) management for biotech crops. Event-specific primers and probes were developed for qualitative and quantitative analysis for biotech maize event 3272 and LY 038 on the basis of the 3' flanking regions, respectively. The qualitative primers confirmed the specificity by a single PCR product and sensitivity to 0.05% as a limit of detection (LOD). Simplex and duplex quantitative methods were also developed using TaqMan real-time PCR. One synthetic plasmid was constructed from two taxon-specific DNA sequences of maize and two event-specific 3' flanking DNA sequences of event 3272 and LY 038 as reference molecules. In-house validation of the quantitative methods was performed using six levels of mixing samples, from 0.1 to 10.0%. As a result, the biases from the true value and the relative deviations were all within the range of +/-30%. Limits of quantitation (LOQs) of the quantitative methods were all 0.1% for simplex real-time PCRs of event 3272 and LY 038 and 0.5% for duplex real-time PCR of LY 038. This study reports that event-specific analytical methods were applicable for qualitative and quantitative analysis for biotech maize event 3272 and LY 038.
Husaini, Amjad M; Tuteja, Narendra
Biotechnological intervention in the development of crops has opened new vistas in agriculture. Central to the accomplishment of the Millennium Development Goals (MDGs), biotech-agriculture is essential in meeting these targets. Biotech crops have already made modest contributions toward ensuring food and nutrition security by reducing losses and increasing productivity, with less pesticide input. These crops could help address some of the major challenges in agriculture-based economies created by climate change. Projections of global climate change expect the concentration of greenhouse gases to increase, aridization of the environment to increase, temperature fluctuations to occur sharply and frequently, and spatial and temporal distribution of rainfall to be disturbed-all of which will increase abiotic stress-related challenges to crops. Countering these challenges and to meet the food requirement of the ever-increasing world population (expected to reach 9 billion by 2030) we need to (1) develop and use biotech crops for mitigating adverse climatic changes; (2) develop biotech crops resilient to adverse environmental conditions; and (3) address the issues/non-issues raised by NGO's and educate the masses about the benefits of biotech crops.
Lehrer, S B; Bannon, G A
In recent years, significant attention has been paid to the use of biotechnology to improve the quality and quantity of the food supply due in part to the projected growth in the world population, plus limited options available for increasing the amount of land under cultivation. Alterations in the food supply induced by classical breeding and selection methods typically involve the movement of large portions of genomic DNA between different plant varieties to obtain the desired trait. This is in contrast to techniques of genetic engineering which allows the selection and transfers specific genes from one species to another. The primary allergy risk to consumers from genetically modified crops may be placed into one of three categories. The first represents the highest risk to the allergic consumer is the transfer of known allergen or cross-reacting allergen into a food crop. The second category, representing an intermediate risk to the consumer, is the potential for replacing the endogenous allergenicity of a genetically-modified crop. The last category involves expression of novel proteins that may become allergens in man and generally represents a relatively low risk to the consumer, although this possibility has received attention of late. In order to mitigate the three categories of potential allergy risk associated with biotech crops, all genes introduced into food crops undergo a series of tests designed to determine if the biotech protein exhibits properties of known food allergens. The result of this risk assessment process to date is that no biotech proteins in foods have been documented to cause allergic reactions. These results indicate that the current assessment process is robust, although as science of allergy and allergens evolves, new information and new technology should help further the assessment process for potential allergenicity.
Brännback, Malin; Carsrud, Alan; Renko, Maija; Ostermark, Ralf; Aaltonen, Jaana; Kiviluoto, Niklas
This paper reports on preliminary findings on a study of the relationship of growth and profitability among small privately held Finnish Life Science firms. Previous research results concerning growth and profitability are mixed, ranging from strongly positive to a negative relationship. The conventional wisdom states that growth is a prerequisite for profitability. Our results suggest that the reverse is the case. A high profitability-low growth biotech firm is more probably to make the transition to high profitability-high growth than a firm that starts off with low profitability and high growth.
Llorente, Briardo; Alonso, Guillermo D; Bravo-Almonacid, Fernando; Rodríguez, Vanina; López, Mariana G; Carrari, Fernando; Torres, Héctor N; Flawiá, Mirtha M
It is expected that the next generation of biotech crops displaying enhanced quality traits with benefits to both farmers and consumers will have a better acceptance than first generation biotech crops and will improve public perception of genetic engineering. This will only be true if they are proven to be as safe as traditionally bred crops. In contrast with the first generation of biotech crops where only a single trait is modified, the next generation of biotech crops will add a new level of complexity inherent to the mechanisms underlying their output traits. In this study, a comprehensive evaluation of the comparative safety approach on a quality-improved biotech crop with metabolic modifications is presented. Three genetically engineered potato lines with silenced polyphenol oxidase (Ppo) transcripts and reduced tuber browning were characterized at both physiological and molecular levels and showed to be equivalent to wild-type (WT) plants when yield-associated traits and photosynthesis were evaluated. Analysis of the primary metabolism revealed several unintended metabolic modifications in the engineered tubers, providing evidence for potential compositional inequivalence between transgenic lines and WT controls. The silencing construct sequence was in silico analysed for potential allergenic cross-reactivity, and no similarities to known allergenic proteins were identified. Moreover, in vivo intake safety evaluation showed no adverse effects in physiological parameters. Taken together, these results provide the first evidence supporting that the safety of next generation biotech crops can be properly assessed following the current evaluation criterion, even if the transgenic and WT crops are not substantially equivalent.
Brookes, Graham; Barfoot, Peter
A critical feature in evaluating the global value of crop biotechnology in agriculture must include an assessment of its economic impact at the farm level. This paper follows earlier studies which examined economic impacts on yields, key costs of production, direct farm income, indirect (non-pecuniary) farm level income effects and impacts on the production base of the four main crops of soybeans, corn, cotton and canola. The commercialization of biotech crops is continuing to proceed rapidly, with significant changes in the overall level of adoption and impact taking place in 2010. This updated analysis shows that there have been substantial net economic benefits at the farm level amounting to $14 billion in 2010 and $78.4 billion for the 15-year period (in nominal terms). The non-pecuniary benefits associated with the use of the technology have also had a positive impact on adoption (in the US accounting for the equivalent of 22% of the total US direct farm income benefit). Biotech crops are, moreover, making important contributions to increasing global production levels of the four main crops. They have, for example, now added 97.5 million tons and 159 million tons respectively, to the global production of soybeans and corn since the introduction of the technology in the mid-1990s.
DiBello, Lia; Missildine, Whit; Struttman, Marie
This paper describes a two-year study in which high levels of performance were achieved and sustained among so-called low-level workers in a biotech company. The purpose of the study--funded by National Science Foundation and lnvitrogen Corporation--were to explore the effectiveness of an accelerated learning Operational Simulation (OpSim)…
Luciani, Francesca; Galluzzo, Sara; Gaggioli, Andrea; Kruse, Nanna Aaby; Venneugues, Pascal; Schneider, Christian K; Pini, Carlo; Melchiorri, Daniela
Quality by design (QbD) is an innovative approach to drug development that has started to be implemented into the regulatory framework, but currently mainly for chemical drugs. The recent marketing authorization of the first monoclonal antibody developed using extensive QbD concepts in the European Union paves the way for future further regulatory approvals of complex products employing this cutting-edge technological concept. In this paper, we report and comment on insights and lessons learnt from the non-public discussions in the European Medicines Agency's Biologicals Working Party and Committee for Medicinal Products for Human Use on the key issues during evaluation related to the implementation of an extensive QbD approach for biotechnology-derived medicinal products. Sharing these insights could prove useful for future developments in QbD for biotech products in general and monoclonal antibodies in particular.
本着“整合资源，培育品牌，多方受益”的原则，世博集团上海现代国际展览有限公司、上海科技会展有限公司和德国汉诺威展览公司将在2007年7月4-6日联手推出“2007中国国际生物技术和仪器设备博览会。（BIOTECH CHINA 2007），三大展览公司携手打造的此次展会预计展出面积6000m2。
Shaik, Munawar A; Dhakre, Ankita; Rathore, Anurag S; Patil, Nitin
A general mathematical framework has been proposed in this work for scheduling of a multiproduct and multipurpose facility involving manufacturing of biotech products. The specific problem involves several batch operations occurring in multiple units involving fixed processing time, unlimited storage policy, transition times, shared units, and deterministic and fixed data in the given time horizon. The different batch operations are modeled using state-task network representation. Two different mathematical formulations are proposed based on discrete- and continuous-time representations leading to a mixed-integer linear programming model which is solved using General Algebraic Modeling System software. A case study based on a real facility is presented to illustrate the potential and applicability of the proposed models. The continuous-time model required less number of events and has a smaller problem size compared to the discrete-time model.
Hennemann, Stefan; Liefner, Ingo
Science and technology systems - and their epistemic communities - are usually hierarchical and composed of a number of strong, large, leading organizations, along with a number of smaller and less influential ones. Moreover, these hierarchical patterns have a spatial structure: the leading organizations are concentrated in a few places, creating a science and technology center, whereas the majority of locations are peripheral. In the example of biotech research in China, we found dynamic changes in center-periphery patterns. These results are based on a network analysis of evolving co-authorship networks from 2001 to 2009 that were built combining national and international databases. Therefore, our results are not only relevant for evaluating the spatial structure and dynamics in the Chinese biotech system and its integration into the global knowledge network, but also revive a discussion on persistence and processes of change in the systems theory for sciencebased industries.
Now in its third year, the Biotech Outsourcing Strategies (BOS) meeting organized by Bio2Business took place at the Søhuset Conference Centre in Hørsholm, Copenhagen. The focus of this year's event was the demanding and challenging area of chemistry, manufacturing and controls (CMC), and the meeting provided ample opportunity for lively discussion of the key issues surrounding this area. New for the 2010 conference, a biologics-focused lecture stream ran in parallel to the established small molecule stream. Both streams boasted a distinguished panel of keynote speakers who discussed all aspects of CMC from early stage scale-up through late stage clinical development. In addition to the keynote speakers, selected contract research organizations (CROs) gave short presentations on the solutions that they could provide to some of the challenges facing CMC. The meeting attracted more than 150 delegates from leading drug development companies and CRO service providers, and greatly facilitated the forging of new working relationships through pre-arranged one-to-one meetings. Moreover, exhibitions from event sponsors and considerable scheduled networking time over lunch and evening reception further enhanced the highly productive and interactive nature of the meeting.
Vasil, Indra K
Plant biotechnology is founded on the principles of cellular totipotency and genetic transformation, which can be traced back to the Cell Theory of Matthias Jakob Schleiden and Theodor Schwann, and the discovery of genetic transformation in bacteria by Frederick Griffith, respectively. On the 25th anniversary of the genetic transformation of plants, this review provides a historical account of the evolution of the theoretical concepts and experimental strategies that led to the production and commercialization of biotech (transformed or transgenic) plants expressing many useful genes, and emphasizes the beneficial effects of plant biotechnology on food security, human health, the environment, and conservation of biodiversity. In so doing, it celebrates and pays tribute to the contributions of scores of scientists who laid the foundation of modern plant biotechnology by their bold and unconventional thinking and experimentation. It highlights also the many important lessons to be learnt from the fascinating history of plant biotechnology, the significance of history in science teaching and research, and warns against the danger of the growing trends of ignoring history and historical illiteracy.
Ezezika Obidimma C
Full Text Available Abstract The development of agricultural biotechnology humanitarian projects for food security in the last five years has been rapid in developing countries and is expected to rise sharply over the coming years. An extremely critical issue in these projects involves building trust with the community and farmers they aim to serve. For the first time, our social audit engagement with one of these initiatives, the Water Efficient Maize for Africa project, has revealed that a critical but unrecognized component of building trust with farmers involves publicly addressing the concerns surrounding stacked trait crops. As a result, we argue in this article that it is critical to actively anticipate the concerns that could be raised over trait stacking by incorporating them into global access plans of such initiatives early in order to facilitate adoption, provide the best value to the small-scale farmer and gain trust with the community whom these projects aim to serve. This perspective, based on an actual international social audit, should be of value to scientists, funders and partners involved in biotech development initiatives for food security.
Ricroch, Agnès E; Hénard-Damave, Marie-Cécile
Most of the genetically modified (GM) plants currently commercialized encompass a handful of crop species (soybean, corn, cotton and canola) with agronomic characters (traits) directed against some biotic stresses (pest resistance, herbicide tolerance or both) and created by multinational companies. The same crops with agronomic traits already on the market today will continue to be commercialized, but there will be also a wider range of species with combined traits. The timeframe anticipated for market release of the next biotech plants will not only depend on science progress in research and development (R&D) in laboratories and fields, but also primarily on how demanding regulatory requirements are in countries where marketing approvals are pending. Regulatory constraints, including environmental and health impact assessments, have increased significantly in the past decades, delaying approvals and increasing their costs. This has sometimes discouraged public research entities and small and medium size plant breeding companies from using biotechnology and given preference to other technologies, not as stringently regulated. Nevertheless, R&D programs are flourishing in developing countries, boosted by the necessity to meet the global challenges that are food security of a booming world population while mitigating climate change impacts. Biotechnology is an instrument at the service of these imperatives and a wide variety of plants are currently tested for their high yield despite biotic and abiotic stresses. Many plants with higher water or nitrogen use efficiency, tolerant to cold, salinity or water submergence are being developed. Food security is not only a question of quantity but also of quality of agricultural and food products, to be available and accessible for the ones who need it the most. Many biotech plants (especially staple food) are therefore being developed with nutritional traits, such as biofortification in vitamins and metals. The main
Gatehouse, A M R; Ferry, N; Edwards, M G; Bell, H A
With a projected population of 10 billion by 2050, an immediate priority for agriculture is to achieve increased crop yields in a sustainable and cost-effective way. The concept of using a transgenic approach was realized in the mid-1990s with the commercial introduction of genetically modified (GM) crops. By 2010, the global value of the seed alone was US $11.2 billion, with commercial biotech maize, soya bean grain and cotton valued at approximately US $150 billion. In recent years, it has become evident that insect-resistant crops expressing δ-endotoxin genes from Bacillus thuringiensis have made a significant beneficial impact on global agriculture, not least in terms of pest reduction and improved quality. However, because of the potential for pest populations to evolve resistance, and owing to lack of effective control of homopteran pests, alternative strategies are being developed. Some of these are based on Bacillus spp. or other insect pathogens, while others are based on the use of plant- and animal-derived genes. However, if such approaches are to play a useful role in crop protection, it is desirable that they do not have a negative impact on beneficial organisms at higher trophic levels thus affecting the functioning of the agro-ecosystem. This widely held concern over the ecological impacts of GM crops has led to the extensive examination of the potential effects of a range of transgene proteins on non-target and beneficial insects. The findings to date with respect to both commercial and experimental GM crops expressing anti-insect genes are discussed here, with particular emphasis on insect predators and parasitoids.
Scupola, Ada; Steinfield, Charles
in an industrial cluster might utilize and derive benefit from a public, broadband ICT infrastructure, particularly in support of e-commerce applications. A case study of a successful biotech cluster in Denamrk and Sweden-The Medicon Valley-provides a preliminary test of these expectations. Distinctions in uses...... and benefits based upon firm size are considered. A key finding is that small firms that would not otherwise be expected to gain from global e-commerce can rely on the cluster "brand" to enable trade with unknown and distant partners....
The year 1958, when DNA was first made in a test tube, marked the birth of modern biotechnology. DNA has now developed into an important technology that makes a key contribution in various sectors such as agriculture, environment and cleansing, and it has triggered a veritable boom in medicine. Today, biologics account for more than 60% of newly approved drugs. They are efficient, save time and money and have few or minimal side effects, fuelling the appetite of big pharma to take over biotech companies. Where will the journey lead?
Full Text Available Much research has been carried out on the accumulation and effective use of knowledge as a company-specific form of intellectual property. However, insufficient attention has been given to research focusing on the effects of micro-level knowledge absorption and its effective use. In this paper, we try to demonstrate what should be done in order to promote new biotech business from the perspective of each engineer’s knowledge, through a micro-level investigation focusing on the life science business section of one IT enterprise. Based on the results of a questionnaire survey of engineers, interviews of several engineers, and patent data analysis, we discuss the progress of the biotech business in an IT enterprise from the aspect of accumulation and circulation of knowledge in a core technology field, the IT business, and a technology field of new entry, the biotech business. This paper reports that the positive growth cycle of biotech business promotion in an IT enterprise, using Hitachi Software Engineering Co., Ltd. as a case, attained by incorporating the latest biotech knowledge from junior engineers and utilizing IT knowledge from middle engineers leads to the recruiting of qualified students.Keywords: accumulation and circulation of the knowledge, biotech business, open innovation, patent data analysis, questionnaire survey
@@ 2008"中国国际生物技术和仪器设备博览会"(BIOTECH CHINA)和"上海国际生物技术与医药研讨会"(BIO-FOURM).将于5月28～30日在上海国际展览中心及上海国际会议中心举办.
Severino, Patrícia; Andreani, Tatiana; Jäger, Alessandro; Chaud, Marco V; Santana, Maria Helena A; Silva, Amélia M; Souto, Eliana B
Insulin was used as model protein to developed innovative Solid Lipid Nanoparticles (SLNs) for the delivery of hydrophilic biotech drugs, with potential use in medicinal chemistry. SLNs were prepared by double emulsion with the purpose of promoting stability and enhancing the protein bioavailability. Softisan(®)100 was selected as solid lipid matrix. The surfactants (Tween(®)80, Span(®)80 and Lipoid(®)S75) and insulin were chosen applying a 2(2) factorial design with triplicate of central point, evaluating the influence of dependents variables as polydispersity index (PI), mean particle size (z-AVE), zeta potential (ZP) and encapsulation efficiency (EE) by factorial design using the ANOVA test. Therefore, thermodynamic stability, polymorphism and matrix crystallinity were checked by Differential Scanning Calorimetry (DSC) and Wide Angle X-ray Diffraction (WAXD), whereas the effect of toxicity of SLNs was check in HepG2 and Caco-2 cells. Results showed a mean particle size (z-AVE) width between 294.6 nm and 627.0 nm, a PI in the range of 0.425-0.750, ZP about -3 mV, and the EE between 38.39% and 81.20%. After tempering the bulk lipid (mimicking the end process of production), the lipid showed amorphous characteristics, with a melting point of ca. 30 °C. The toxicity of SLNs was evaluated in two distinct cell lines (HEPG-2 and Caco-2), showing to be dependent on the concentration of particles in HEPG-2 cells, while no toxicity in was reported in Caco-2 cells. SLNs were stable for 24 h in in vitro human serum albumin (HSA) solution. The resulting SLNs fabricated by double emulsion may provide a promising approach for administration of protein therapeutics and antigens.
Kang, Kyung-Nam; Lee, Yoon-Sik
Research-intensive small and medium-sized enterprises (SMEs) play a crucial role in the advancement of the biotechnology industry. This paper explored the impacts of internal and contextual variables on innovative activity in Korea and compared the results of this analysis with previous studies of other countries. Our analysis of 149 Korean biotech SMEs showed that the ratio of R&D expenditure to sales, the ratio of R&D employees to total employees, CEO characteristics, governmental support and international networking are positively correlated with a firm's innovation performance. The results may help decision makers to better foster SMEs in the Korean biotechnology industry.
The present state of research and exploitation of biotech (GM) crops in horticulture: results of research on plum cv. 'HoneySweet' resistant to plum pox virus (Sharka) and the deregulation of this cultivar in the CR & Europe
Gentically modified (GM) crops were grown world-wide on 160 million ha in 2011. Only 114.57 ha of GM crops were grown in Europe, of that, 114.90 ha were Bt maize and 17 ha were potato for industrial starch production. Commercialization of Biotech crops started in 1995. Currently, developing count...
Biotech drugs are drugs made by modem biotechnology with bioactive substances and their synthetic analogs,using biomass as raw materials.Biotech drugs,including cytokines,recombinant proteins,antibodies,vaccines,and oligonucleotides,have begun to be widely used clinically,and brought revolutionary change for the pharmaceutical industry.However,residual DNA in biological products may be potentially dangerous,so purification processes need to be validated to confirm its clearance.The new United States pharmacopoeia will recommend real-time quantitative PCR method be the only standard method for testing host residual DNA in biotech drugs.This method has the technical advantage of high specificity,high sensitivity,good reproducibility,and quantitative detection,making results more accurate,thereby provides a reliable means of detection in process research and product quality control for biopharmaceutical enterprises.This review compares 4 types of testing methods and focuses on two real-time quantitative methods.%生物技术药物是所有以生物质为原料的生物活性物质及其人工合成类似物通过现代生物技术制得的药物,包括细胞因子、重组蛋白、抗体、疫苗和寡核苷酸等,临床上已开始广泛应用,为制药工业带来了革命性变化.但是生物技术药物中残留DNA可能存在安全性问题,因此应尽可能将产品中残留DNA的水平降到最低.新版美国药典将推荐实时定量PCR法作为生物技术药物中宿主残留DNA检定的唯一标准方法.该法的技术优势在于序列特异性高、灵敏度高、重现性好,还可以实现定量检测,使得结果更为精确,从而为生物技术药物企业在工艺研究和成品质量控制方面提供了可靠的检测手段.此综述对4类检测方法进行了比较,重点比较两种实时定量方法.
This book provides laboratory experiments to enhance any food science/botany curriculum. Chapter 1, "Introduction," presents a survey of the techniques used in plant biotechnology laboratory procedures. Chapter 2, "Micronutrition," discusses media and nutritional requirements for tissue culture studies. Chapter 3, "Sterile Seeds," focuses on the…
Faeh, Andrea Beata
The Court of Justice of the European Union (Court) delivered a preliminary ruling in 2011 in the case of Oliver Brüstle v Greenpeace on the interpretation of Article 6(2) of the Biotech Directive and thereby established an autonomous concept of the term ‘human embryo’. The Brüstle decision raises......, this autonomous interpretation of ‘human embryo’ and the flexibility allowed to the national courts needed further clarification. This clarification was recently given by the Court’s Grand Chamber in International Stem Cell Corporation v Comptroller General Patents where the Court concluded that a non......-fertilised human ovum, not capable of developing into a human being, is not a ‘human embryo’. Hence, ‘where a non-fertilised human ovum does not fulfil that condition [inherent capacity of developing into a human being], the mere fact that that organism commences a process of development is not sufficient...
瑞典是世界上最具创新能力的国家,而其生物科技产业集群贡献的创新成果又是最集中的.瑞典生物科技产业集群主要分布在斯德哥尔摩与乌普萨拉之间、哥德堡周围、隆德与马尔默之间的三大地带.它的主要特征是,形成了一条完整的生产链,并集中分布在这一产业技术链和价值链的高端领域.瑞典生物科技产业集群整体实力强大,并拥有雄厚的研发力量,拥有优越的成长环境,它创造了众多举世瞩目的新成果.%Sweden is the most innovative cowntry in the world, and its contribution to biotechnology industry cluster innovation is the most concentrated. Swedish biotech industry clusters are mainly distributed in Stockholm and Uppsala, Gothenburg around Lund and Malm area. Its main feature is that it has a complete production chain, and it is concentrated in the industrial technology and value chain is in the high end. Swedish biotech industry cluster has a strong research and development strength and a superior environment for the growth. It has created many remarkable new results.
王友同; 吴文俊; 李谦; 高美风
Biological technology is the topic height at the development of economy and technology in the 21st century all over the world . The authors based on the world biotech- drugs total development trend, summarized the biotech drugs research achievements in recent five years in China. The content includes: cytokine, protein and peptide drugs, fusion protein, cell-penetrating peptides, enzymes,gene therapy,stem cells,monoclonal antibodies,therapeutic vaccine,polysaccharide drugs,etc. It is found in the survey that the development of biotech drugs has a bright future in treating complicated diseases, protecting the human health, improving the life quality, and developing the biotech drugs industry, thank to the emerging of many creative biotech drug researches within our country. This paper provides the reference for establishing the relevant research plan, deciding the research project, setting development goals for enterprise research,and choosing professional development direction,and to biological pharmaceutical researchers.%生物技术是21世纪世界各国竞相发展的经济、技术的制高点,作者站在世界生物技术药物发展总趋势的高度上,具体而微地调查和总结了我国近5年来生物技术药物研究所取得的成果,内容包括:细胞因子、其它蛋白质和多肽药物、融合蛋白、穿膜肽、酶、基因治疗、干细胞、单克隆抗体、治疗性疫苗及多糖药物等.调查发现,在攻克人类顽疾、保障人民身体健康、提高生活质量和发展我国生物技术药物产业方面,由于国内成批有创见的研究成果持续涌现,发展前景一片光明.该文可为有关部门科研规划、确定研究项目、企业锁定发展目标及生物制药人员选择专业发展方向提供参考.
Lin, Fangyu; Wang, Shyh-Jen
To demonstrate the influence of the US Supreme Court's KSR case, our analysis has shown that the ratio of obvious ruling increased from 0.42 to 0.62 after this case, whereas the ratio of non-obvious ruling decreased from 0.47 to 0.28. Therefore, without the rigid application of a "teaching, suggestion or motivation" test, the trends of obvious and non-obvious CAFC rulings significantly increased and decreased, respectively. Based on this analysis, biotech inventors should contemplate the factors that have resulted in ruling of obviousness, which include claims that are too broad, the lack of secondary considerations, the reasonable expectation of success, and the reason or motivation to create a structure based on structural similarity. The presence of these factors most likely would result in the rejection of the claim during patent prosecution or the invalidation of the claim in patent litigation. Two immunotherapy and vaccine cases have applied these factors to overcome the obvious rejections.
For years, purified and isolated naturally occurring biological substances of great medical importance--including genes--have been the subject of U.S. patents. Similarly, methods in which the detection of a biological substance (e.g., in a blood sample) dictates subsequent actions, as in disease diagnostics and treatment, have long enjoyed patent protection. However, two recent Supreme Court cases, Association for Molecular Pathology v. Myriad Genetics, Inc. (133 S. Ct. 2107) (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (132 S. Ct. 1289) (2012), have shaken up the status quo of biotech patenting. The highest court in our land unanimously agreed with patent challengers that much of what we took for granted as patentable subject matter is not, as a matter of law, eligible for patenting after all. This review discusses the Myriad and Mayo cases, their impact on which biology-based innovations we may or may not continue to patent, and whether the altered status quo is benignly corrective or gravely disruptive. Is what happened here a good thing or not?
Grech, Godfrey; Fenech, Anthony
The recent years has seen significant growth in a new therapeutic approach to the management of disease. Biological therapeutic agents, constitute a broad category of drugs, usually generated by recombinant techniques from living organisms. These therapies revolutionise the traditional approaches to drug design and development, and regulatory agencies have been swift in developing the necessary structures to ensure their optimal use.
Over the past forty years, microgravity has inspired and enabled applications in a wide range of sectors including medicine, materials, computers, communications, and national defense. Trends show that demand for high-tech solutions is increasing in these sectors, solutions that require higher resolution, greater precision, novel materials, innovative processes, and more sophisticated tools. These are areas where microgravity can offer unique capabilities for innovation. The Emerging Space Office (ESO) has engaged in multiple studies over the past year that have found that microgravity RD is one of the most promising technology areas for contributing to economic growth and to NASAs mission. The focus of these studies was on terrestrial markets rather than NASA applications, applied research rather than basic research, and commercial rather than academic investigators. There have been more success stories than are generally appreciated and there are significant areas of promising future potential. Many of the problems that have limited commercial microgravity development in the past are being solved. Microgravity research and development (RD) requires iteration and learning, as rapidly as possible. New technologies enable high throughput and rapid data collection in increasingly small payloads. The International Space Station is in orbit and provides a laboratory that is available 247 at least until 2024. Frequent flights by commercial space providers to and from the ISS now enable the fast learning cycles needed by high-tech industries. Launch costs are decreasing and the ability to return payloads to Earth is increasing. New commercial space laboratories, such as those being developed by SpaceX and Bigelow Aerospace, are in the final stages of development and testing. This ecosystem for microgravity RD has never been available before. These are game-changer conditions for attracting high-tech industries to space for terrestrial, as well as NASA, applications. However, few know that these capabilities are available or how to use them. In aggregate, the potential value for new applications from microgravity RD over the next ten years could add billions of dollars per year in terrestrial applications to the future economy, create new jobs, and generate a wide range of public benefits in medical advances, while broadening the customer base for the emerging space industry.
This annual Methods and Advances Special Issue of Biotechnology Journal contains a selection of cutting-edge research and review articles with a particular emphasis on vertical process understanding – read more in this editorial by Prof. Alois Jungbauer, BTJ co-Editor-in-Chief.
Efforts to change the genetic makeup of plants have been ongoing since the beginning of agriculture, thousands of years ago. Early plant improvements relied on simply cross-breeding cultivars with desired traits. Advancements in mutation breeding through chemicals and radiation ...
Rude, Mathew A; Schirmer, Andreas
Bioethanol and plant oil-derived biodiesel are generally considered first generation biofuels. Recognizing their apparent disadvantages, scientists and engineers are developing more sustainable and economically feasible second generation biofuels. The new microbial fuels summarized here have great potential to become viable replacements or at least supplements of petroleum-derived liquid transportation fuels. Yields and efficiencies of the four metabolic pathways leading to these microbial fuels-mostly designed and optimized in Escherichia coli and Saccharomyces cerevisiae using modern tools of metabolic engineering and synthetic biology-and the robustness of the biocatalysts that convert the metabolic intermediates to, in some cases, finished and engine-ready fuels, will determine if they can be commercially successful and contribute to alleviating our dependence on fossil fuels.
Full Text Available Recently, the intended positive effects of the current patent system in biotechnological research have been widely questioned. As part of this review, it is discussed here one of the foundations of the model. The assumption of the indispensability of patents is examined through the analysis of their expected benefits; namely, that patents are suitable to ensure access to information, access to and use of inventions and, finally, that they should promote both creativity and research. Applied to synthetic biology, in spite of newly discovered techniques and promising products, this approach reveals that this discipline also encounters similar issues. However, it also offers a new vision of intellectual property rights and their effects on research, which is based on a different conception of the commons and its relationship with private ownership of intangible assets in the knowledge economy.
Additionally, the use of analytical methods (analytics) is underuti- lized. Some are as simple as earned value management (EVM). This simple quantitative...of the many opportunities bureaucrats possess to insert themselves between program managers and program or weapon system delivery. The size and role...across programs. Fortune 500 firms have strategic risk- management offices, managing strategic corporate risks with respect to normalized risk appetite
Buttel, Frederick H.
Synthesizes findings with personal estimates of likely impacts of biotechnology on nonmetropolitan economy, farming, public research institutions. Indicates biotechnology's benefit to rural America may come in expanded demand for raw materials although drawbacks may include declining farm numbers and displacement of rural workers in…
Baldwin, A; Wiley, E
VitaResc (formerly Apex) is developing PHP-HT, pyridoxalated hemoglobin polyoxyethylene conjugate, for the potential treatment of nitric oxide-induced shock (characterized by hypotension), associated with various etiologies, initially in septic shock. A phase I safety study and an initial phase I/II patient trial for NO-induced shock have been completed, and VitaResc has enrolled patients in three of five planned cohorts in a continuation of these trials to include a protocol of continuous infusion and dose escalation [330680,349187,390918]. The results from the dose escalation trials are expected to provide the basis for a randomized, controlled phase II/III pivotal trial of PHP-HT . VitaResc has licensed PHP-HT exclusively from Ajinomoto for all indications, worldwide, except Japan . Ajinomoto originally developed the human derived and chemically modified hemoglobin preparation as a blood substitute, but no development has been reported by the company since 1997 [275277,303577]. The other potential indications of PHP-HT include shock associated with burns, pancreatitis, hemodialysis and cytokine therapies . VitaResc expects the annual market potential of PHP-HT to exceed 1 billion dollars .
Potato is the world's most important vegetable crop, with nearly 400 million tons produced worldwide every year, lending to stability in food supply and socioeconomics. In general, potato is an intensively managed crop, requiring irrigation, fertilization, and frequent pesticide applications in orde...
Elena V. Luneva
Full Text Available in article, on basis of works of Russian and foreign academic lawyers, biologists, microbiologists, zoologists, genetics and also representatives of other sciences of natural-science branch, is researched legal relationship on production and distribution of biotechnological products in the Russian Federation, The law provision in considered sphere is highly unified. Peculiarities of legal mode of biotechnological products are not taken into account. Specification and differentiation of legal regulation of relations on production and distribution of biotechnological products is required. Absence of legal definition of "biotechnology" leads to ambiguity of their legal mode and low efficiency of legal regulation. Reasonability of development of separate legal classification by potential hazard of gene-engineering activity for ecological systems is grounded. Necessity of assignment of legal measures directed on development of biotechnologies and active involvement of biotechnological methods into diverse segments of economic and social provision of human is detected. Conclusion is made about the fact that proportion of stimulation and limitation in legal regulation of production and distribution of biotechnological products should be such that maximally complete application of achievements and developments of biotechnology in production with minimal risk of adverse impact on human and natural environment may occur.
Holmgreen, Lise-Lotte; Vestergaard, Torben
It is well known that news texts are not value neutral and that in these texts even genuinely factual statements can function as evaluations. Hence, only an analysis of the types of evaluation used will reveal the true picture of the attitudinal import of reporting texts. The paper explores...
... meet certain conditions and best satisfy the selection criteria as outlined below. A minimum of 10 and... conference evening dinner on November 1. Conditions for Participation An applicant must submit a completed... mission Referrals from political organizations and any documents containing references to...
Drozdoff, Vladimir; Fairbairn, Daryl
Appropriate negotiation and drafting of license agreements are critical to successfully establishing and managing the expansive and complex relationships that are becoming more common between industry and universities. More often than not, the resulting licensing agreements become quite lengthy and complex, and the key principles become difficult to discern among all the details. This summary provides a short, nonexhaustive introduction to some of the essential components of these licenses with the intent of providing the non-licensing professional a better appreciation of some of the key commercial and legal terms from both an academic and company perspective, keeping in mind some of the considerations that particularly apply to biotechnology deals.
Minssen, Timo; Nilsson, David
- without leaving other rights of the IP family aside, it also explores geographical indications, industrial designs, trade secrets and databases. The collection offers a full and complete picture of European IP Law, discussing the treatment of intrinsic issues on harmonization, transborder disputes......, collectiveness and individualization in the different fields of IP law. With an original introduction by the editor, this book has been carefully designed to offer law students as well as practitioners a valuable instrument to understand contemporary IP law within the EU. 28 Articles, dating from 1994 to 2014...
Julie; Ingwersen; 钱民徵
基因,转基因,基因工程……与“基因”有关的这几个词,几乎成了上世纪末以来的热门词语。这似乎印证了“21世纪属于生物学世纪”这一著名预言。“genetically modified(GM)crops”也成了一个英语热门词汇。本文详细介绍了上世纪六、七十年代所谓绿色革命之父,诺贝尔奖获得者Norman Borlaug对(GM)crops这场新革命的观点。他的观点有两点值得我们关注: 1/为什么当今世界有人反对这场崭新意义的绿色革命?Borlaug的观点非常犀利: If we sit in Europe or North America and decide that because we don’t need that scientific approach for our food supply, therefore they can’t have it either, that is grossly (非常) unethical (不道德的). 2/凡是革命。那就必然会有风险:no agricultural advance is risk-free. Borlaug称,当年的绿色革命也同样遭受了人们的反对:Critics(批评家们)in the past accused the Green Revolution of popularizing (普及) chemical fertilizers, pesticides and irrigation that jeopardized (危害) the environment in developing countries.】
Hansen, Anne Grethe
that regulation and debate changed the rate and direction of new biotechnology development, contributing to technology acceptance, without however ensuring it. The paper thus questions the caricatured assumptions in economics and industrial policy that regulation restrict techno-economic growth. The paper further...... to the European arena, their role and extension are still an issue. In this paper, the often anticipated innovation-inhibiting effects of regulation are questioned by giving an account of regulations and debates in Denmark. An account which includes the shifting positions of industry, the research community...... states regulation and controversies to have contributed actively to the specific technology development, but also states the difficulties in setting radically different technology development agendas....
Andersson, Kjell; Drottz-Sjoberg, Britt-Marie; Espejo, Raul; Fleming, Patricia Ann; Wene, Clas-Otto
Today, societal decisions in areas of complexity are often dominated by one of three alternative ways: (a) by scientists, nowadays often in combination with commercial interest; (b) by politicians alone; and (c) by simply "laissez-faire," or "the tyranny of small steps." None of these three ways of decision making is fully democratic because they…
O'Sullivan, Dermot A.
Describes a six-week program designed to give scientists from developing countries advanced training in biotechnology methods. Stresses the need to provide the participants with "hands-on" experiences to enhance their ability to contribute to biotechnology programs in their home countries and to train others locally. (TW)
This article examines the privacy of personal medical information in the health research context. Arguing that biomedical research in Canada has been caught up in the government's broader neoliberal policy agenda that has positioned biotechnology as a strategic driver of economic growth, the author discusses the tension between informational…
Iurescia, Sandra; Fioretti, Daniela; Fazio, Vito Michele; Rinaldi, Monica
DNA vaccination has been widely explored to develop new, alternative and efficient vaccines for cancer immunotherapy. DNA vaccines offer several benefits such as specific targeting, use of multiple genes to enhance immunity and reduced risk compared to conventional vaccines. Rapid developments in molecular biology and immunoinformatics enable rational design approaches. These technologies allow construction of DNA vaccines encoding selected tumor antigens together with molecules to direct and amplify the desired effector pathways, as well as highly targeted vaccines aimed at specific epitopes. Reliable predictions of immunogenic T cell epitope peptides are crucial for rational vaccine design and represent a key problem in immunoinformatics. Computational approaches have been developed to facilitate the process of epitope detection and show potential applications to the immunotherapeutic treatment of cancer. In this review a number of different epitope prediction methods are briefly illustrated and effective use of these resources to support experimental studies is described. Epitope-driven vaccine design employs these bioinformatics algorithms to identify potential targets of vaccines against cancer. In this paper the selection of T cell epitopes to develop epitope-based vaccines, the need for CD4(+) T cell help for improved vaccines and the assessment of vaccine performance against tumor are reviewed. We focused on two applications, namely prediction of novel T cell epitopes and epitope enhancement by sequence modification, and combined rationale design with bioinformatics for creation of new synthetic mini-genes. This review describes the development of epitope-based DNA vaccines and their antitumor effects in preclinical research against B-cell lymphoma, corroborating the usefulness of this platform as a potential tool for cancer therapy. Achievements in the field of DNA vaccines allow to overcome hurdles to clinical translation. In a scenario where the vaccine industry is rapidly changing from a mostly empirical approach to a rational design approach, these new technologies promise to discover and develop high-value vaccines, creating a new opportunity for future markets.
Engel, Dirk; Mitze, Timo; Patuelli, Roberto
This paper evaluates the R&D enhancing effects of two large public grant schemes for the German biotechnology industry (BioRegio, BioProfi le). Both grant schemes are organized in the form of contents for cooperation with the goal to foster the performance of innovative firms by their organizatio...... to a mobilization of local actors during the application phase could be detected. Finally, first attempts in estimating the long-term effects of the contests for cooperation approach on the winner regions’ R&D activity in the post-treatment period show ambiguous results....
Insects represent the most abundant group of animals on earth, comprising about 800,000 described species, and approximately 10,000 of these species can be actually destructive for human activities. Pest control interventions, alternative to pesticides, are increasingly being implemented within the concept of Integrated Pest Management, involving the biological control to eradicate a pest from the area of interest. This concept has been recently extended also to those hemathoph...
Burns, Lawton R; Housman, Michael G; Robinson, Charles A
Start-up companies in the biotechnology and medical device sectors are important sources of health care innovation. This paper describes the role of venture capital in supporting these companies and charts the growth in venture capital financial support. The paper then uses longitudinal data to describe market entry and exit by these companies. Similar factors are associated with entry and exit in the two sectors. Entries and exits in one sector also appear to influence entry in the other. These findings have important implications for developing innovative technologies and ensuring competitive markets in the life sciences.
Lopez Villar, J.; Freese, B.; Holder, H.; Chandrasekaran, K.; Rodriguez, L.
The biotechnology industry has aggressively touted GM as a solution to hunger and the global food crisis. Their arguments have been accepted by many politicians. This Friends of the Earth International (FoEI) report looks behind the spin and exposes the reasons why GM crops cannot, and are unlikely to ever, contribute to poverty reduction, global food security or sustainable farming (authors' abstract)
Buck, Elizabeth; Mulvihill, Mark; Iwata, Kenneth K
Over the past 2 decades, our increased understanding of tumor biology has resulted in the delivery of a new generation of molecularly targeted cancer drugs with greater efficacy and less toxicity. This understanding has also provided pharmaceutical and academic institutions with a greater appreciation for the complexities and challenges associated with discovering and developing molecularly targeted drugs. To deal with the complexities of tumor biology and the associated technologies needed to develop molecularly targeted drugs, there has been increased cooperation and collaboration between academic and pharmaceutical-industry researchers in a broader number of aspects of the drug discovery and development continuum, including structural biology and translational research. This collaborative effort has played a role in molecularly targeted drugs such as cetuximab, trastuzumab, imatinib, and new promising drug candidates such as OSI-906. Cooperative efforts by industry and academia have also provided important insights to optimize the use of such agents in the clinic. This review aims to emphasize the need for academic/industrial collaborations for success and efficiency through the drug discovery and development continuum, and will highlight several examples of collaborations between academic and industrial scientists that facilitated the development of molecularly targeted antitumor agents into the clinic.
Brockman, Mark; Ordman, Alfred B.; Campbell, A. Malcolm
In the sophomore-level Molecular Biology and Biotechnology course at Beloit College, students learn basic methods in molecular biology in the context of pursuing a semester-long original research project. We are exploring how DNA sequence affects expression levels of proteins. A DNA fragment encoding all or part of the guanylate monokinase (gmk) sequence is cloned into pSP73 and expressed in E. coli. A monoclonal antibody is made to gmk. The expression level of gmk is determined by SDS gel elctrophoresis, a Western blot, and an ELISA assay. Over four years, an increase in enrollment in the course from 9 to 34 students, the 85% of majors pursuing advanced degrees, and course evaluations all support the conclusion that involving students in research during undergraduate courses encourages them to pursue careers in science.
This study explores the value of trust as a construct in understanding how R&D alliances collaborate over time. A review of literature leads to specific expectations on alliance coordination mechanisms needed to be applied by high-tech companies to secure effective cooperation. I pose trust as a pre
Taks, J.L.; Herrmann, A.M.; Moors, E.H.M.
When internal knowledge bases are insufficient for developing innovations, companies tend to collaborate with external R&D partners. According to a long-standing literature on ‘clusters’, ‘industrial districts’, ‘local production systems’ and ‘regional innovation systems’, geographical proximity bet
Full Text Available Organic farming prohibits the use of genetically modified organisms (GMOs inasmuch as their genetic material has been altered in a way that does not occur naturally. In actual fact, there is a conventional identity between GMOs and transgenic organisms, so that genetic modification methods such as somatic hybridization and mutagenesis are equalized to conventional breeding. A loophole in this system is represented by more or less innovative genetic engineering approaches under regulatory discussion, such as cisgenesis, oligonucleotide-directed mutagenesis, and antisense technologies, that are redefining the concept of GMOs and might circumvent the requirements of the GMO legislation and, indirectly, of organic farming.
Hu, Shih-Cheng; Shiue, Angus; Tu, Jin-Xin; Liu, Han-Yang; Chiu, Rong-Ben
For class II, type A2 biological safety cabinets (BSC), NSF/ANSI Standard 49 should be conformed in cabinet airflow velocity derivation, particle contamination, and aerodynamic flow properties. However, there exists a potential problem. It has been built that the cabinet air flow stabilize is influenced by the quantity of downflow of air and the height above the cabinet exhaust opening. Three air downflow quantities were compared as an operating apparatus was placed from 20 to 40 cm above the bench of the cabinet. The results show that the BSC air downflow velocity is a function of increased sampling height, displaying that containment is improvingly permitted over product protection as the sampling height decreases. This study investigated the concentration gradient of particles at various heights and downflow air quantity from the bench of the BSC. Experiment results indicate that performance near the bench was better than in the rest of the BSC. In terms of height, the best cleanliness was measured at a height of 10 cm over the bench; it reduced actually with add in height. The empirical curves accommodate, founded on the concentration gradient of particle created was elaborated for evaluating the particle concentration at different heights and downflow air quantity from the source of the bench of the BSC. The particle image velocimetry system applied for BSC airflow research to fix amount of airflow patterns and air distribution measurement and results of measurements show how obstructions can greatly influence the airflow and contaminant transportation in a BSC.
Researchers in molecular biology are discovering an increasing genetic basis for a wide range of mental diseases, moods, behaviors, and personality traits. Findings are creating the context for a new sociobiology favoring a genetic interpretation of human motivations and drives. Genetic engineering will give some people unprecedented power over…
Gobbi, Alberto; Funeriu, Sandra; Ioannou, John; Wang, Jinyi; Lee, Man-Ling; Palmer, Chris; Bamford, Bob; Hewitt, Robin
While established pharmaceutical companies have chemical information systems in place to manage their compounds and the associated data, new startup companies need to implement these systems from scratch. Decisions made early in the design phase usually have long lasting effects on the expandability, maintenance effort, and costs associated with the information management system. Careful analysis of work and data flows, both inter- and intradepartmental, and identification of existing dependencies between activities are important. This knowledge is required to implement an information management system, which enables the research community to work efficiently by avoiding redundant registration and processing of data and by timely provision of the data whenever needed. This paper first presents the workflows existing at Anadys, then ARISE, the research information management system developed in-house at Anadys. ARISE was designed to support the preclinical drug discovery process and covers compound registration, analytical quality control, inventory management, high-throughput screening, lower throughput screening, and data reporting.
Reiss, Thomas; Woerner, Stefan
Socio-economic research on biotechnology is dealing mainly with the sectors of biopharmaceuticals, agro-food or environmental technologies. In contrast, the equipment and supplies sector seems to be largely ignored. This is surprising because this sector provides important input in terms of technology and material for the development of biotechnology in general. Our comparative analysis of the sector in eight countries indicates that there exists no specific science base for the sector and that it is largely neglected by public research funding. Commercial activities are concentrated in countries with a large general science base in biotechnology and strong multinational pharmaceutical or chemical companies. There is a rather broad diversity in the way the sector has developed in the eight countries. Our data support the notion that national peculiarities seem dominant for explaining this picture. We anticipate growing business opportunities for European firms to step into large markets of equipment and supplies for functional genomics and protein analyses where Europe maintains a strong science base.
On 30 December 2008, the Regulation (EC) 1394/2007 on advanced therapy medicinal products (ATMPs) entered into force. Herewith the first EU-wide regulatory framework for ATMPs was established. It requires a central marketing authorisation application to the EMA (European Medicinal Agency). This new framework especially changes the code of regulatory practice for tissue engineered products (TEPs), as no registration procedure had been previously required for autologous TEPs. This also meant that no clinical proof of efficacy achieved by a pivotal clinical trial was necessary. Difficulties and their background as well as the vast requirements for product development that have to be addressed by small companies within a very short time frame are presented. Hereby, it is obvious that regulatory experience which is required to identify and implement the resulting implications was not in place yet and still had to be established. The lack of regulatory experience also resulted in difficulties with scientific advice preparation, expectations toward regulatory agencies, consultants, and transformation of regulatory requirements. Addressing the regulatory requirements within the transition period is even more difficult for entrepreneurs with products which are assigned for indications resulting in complex challenges to the trial design. Due to the enormous time pressure to generate data and due to the implied financial pressure, different adaptation strategies are evolving. In Germany the "hospital exemption" according to §4b AMG (German Medicinal Products Law) is of major importance. A reorientation toward acellular products and a slow down in development of new ATMP products is expected.
Patron, Nicola J
Synthetic biology aims to apply engineering principles to the design and modification of biological systems and to the construction of biological parts and devices. The ability to programme cells by providing new instructions written in DNA is a foundational technology of the field. Large-scale de novo DNA synthesis has accelerated synthetic biology by offering custom-made molecules at ever decreasing costs. However, for large fragments and for experiments in which libraries of DNA sequences are assembled in different combinations, assembly in the laboratory is still desirable. Biological assembly standards allow DNA parts, even those from multiple laboratories and experiments, to be assembled together using the same reagents and protocols. The adoption of such standards for plant synthetic biology has been cohesive for the plant science community, facilitating the application of genome editing technologies to plant systems and streamlining progress in large-scale, multi-laboratory bioengineering projects.
Holzhauser, Thomas; Ree, Ronald van; Poulsen, Lars K; Bannon, Gary A
There is detailed guidance on how to perform bioinformatic analyses and enzymatic degradation studies for genetically modified crops under consideration for approval by regulatory agencies; however, there is no consensus in the scientific community on the details of how to perform IgE serum studies. IgE serum studies are an important safety component to acceptance of genetically modified crops when the introduced protein is novel, the introduced protein is similar to known allergens, or the crop is allergenic. In this manuscript, we describe the characteristics of the reagents, validation of assay performance, and data analysis necessary to optimize the information obtained from serum testing of novel proteins and genetically modified (GM) crops and to make results more accurate and comparable between different investigations.
Wojtczyk, Martin; Panin, Giorgio; Röder, Thorsten; Lenz, Claus; Nair, Suraj; Heidemann, Rüdiger; Goudar, Chetan; Knoll, Alois
After utilizing robots for more than 30 years for classic industrial automation applications, service robots form a constantly increasing market, although the big breakthrough is still awaited. Our approach to service robots was driven by the idea of supporting lab personnel in a biotechnology laboratory. After initial development in Germany, a mobile robot platform extended with an industrial manipulator and the necessary sensors for indoor localization and object manipulation, has been shipped to Bayer HealthCare in Berkeley, CA, USA, a global player in the sector of biopharmaceutical products, located in the San Francisco bay area. The determined goal of the mobile manipulator is to support the off-shift staff to carry out completely autonomous or guided, remote controlled lab walkthroughs, which we implement utilizing a recent development of our computer vision group: OpenTL - an integrated framework for model-based visual tracking.
Liao, Wei-Ching; Chuang, Min-Chieh; Ho, Ja-An Annie
Genetically modified (GM) technique, one of the modern biomolecular engineering technologies, has been deemed as profitable strategy to fight against global starvation. Yet rapid and reliable analytical method is deficient to evaluate the quality and potential risk of such resulting GM products. We herein present a biomolecular analytical system constructed with distinct biochemical activities to expedite the computational detection of genetically modified organisms (GMOs). The computational mechanism provides an alternative to the complex procedures commonly involved in the screening of GMOs. Given that the bioanalytical system is capable of processing promoter, coding and species genes, affirmative interpretations succeed to identify specified GM event in terms of both electrochemical and optical fashions. The biomolecular computational assay exhibits detection capability of genetically modified DNA below sub-nanomolar level and is found interference-free by abundant coexistence of non-GM DNA. This bioanalytical system, furthermore, sophisticates in array fashion operating multiplex screening against variable GM events. Such a biomolecular computational assay and biosensor holds great promise for rapid, cost-effective, and high-fidelity screening of GMO.
Tanski, Anne E.; Bobick, Sandra; Mosley-Turner, Katherine; Garofalo, Giovanni
Given biotechnology's emergence as a major competitor in the Pittsburgh region, critically linking education to industry through the Community College of Allegheny County's Biotechnology Workforce Collaborative (BWC) provided a well-trained workforce. The collaborative also sought to increase the number of women in the sciences, specifically…
Incubators, accelerators, innovation centers, launch pads. Everyone defines the idea a bit differently, but, generally, these infrastructures refer to a subsidized space where fledgling companies get support?a combination of mentorship, funding, low rent, networking opportunities, and other training?with the goal of propelling early businesses to success.
Ezezika Obidimma C
Full Text Available Abstract Background Agricultural biotechnology public-private partnerships (PPPs have been recognized as having great potential in improving agricultural productivity and increasing food production in sub-Saharan Africa. However, there is much public skepticism about the use of GM (genetically modified crops and suspicion about private sector involvement in agbiotech projects. This case study sought to understand the role of trust in the Bacillus thuringiensis (Bt cotton in Burkina Faso project by exploring practices and challenges associated with trust-building, and determining what makes these practices effective from the perspective of multiple stakeholders. Methods We conducted semi-structured, face-to-face interviews to obtain stakeholders’ understanding of trust in general as well as in the context of agbiotech PPPs. Relevant documents and articles were analyzed to generate descriptions of how trust was operationalized in this evolving agbiotech PPP. Data was analyzed based on emergent themes to create a comprehensive narrative on how trust is understood and built among the partners and with the community. Results We derived four key lessons from our findings. First, strong collaboration between research, industry and farmers greatly contributes to both the success of, and fostering of trust in, the partnership. Second, this case study also revealed the important, though often unrecognized, role of researchers as players in the communication strategy of the project. Third, effective and comprehensive communication takes into account issues such as illiteracy and diversity. Fourth, follow-up at the field level and the need for a multifaceted communications strategy is important for helping push the project forward. Conclusions Burkina Faso’s well-established and effective cotton selling system laid the foundation for the implementation of the Bt cotton project – particularly, the strong dialogue and the receptivity to collaboration. Interviewees reported that establishing and maintaining trust among partners, researchers and the community in Burkina Faso greatly contributed to the success of the PPP. By addressing challenges to building trust and engaging in trust-building practices early on, improvements in the effectiveness of agbiotech PPPs are likely.
Rajadhyaksha, Manoj; Subramanyam, Meena; Rup, Bonnie
The immunogenicity profile of a biotherapeutic is determined by multiple product-, process- or manufacturing-, patient- and treatment-related factors and the bioanalytical methodology used to monitor for immunogenicity. This creates a complex situation that limits direct correlation of individual factors to observed immunogenicity rates. Therefore, mechanistic understanding of how these factors individually or in concert could influence the overall incidence and clinical risk of immunogenicity is crucial to provide the best benefit/risk profile for a given biotherapeutic in a given indication and to inform risk mitigation strategies. Advances in the field of immunogenicity have included development of best practices for monitoring anti-drug antibody development, categorization of risk factors contributing to immunogenicity, development of predictive tools, and development of effective strategies for risk management and mitigation. Thus, the opportunity to ask "where we are now and where we would like to go from here?" was the main driver for organizing an Open Forum on Improving Immunogenicity Risk Prediction and Management, conducted at the 2012 American Association of Pharmaceutical Scientists' (AAPS) National Biotechnology Conference in San Diego. The main objectives of the Forum include the following: to understand the nature of immunogenicity risk factors, to identify analytical tools used and animal models and management strategies needed to improve their predictive value, and finally to identify collaboration opportunities to improve the reliability of risk prediction, mitigation, and management. This meeting report provides the Forum participant's and author's perspectives on the barriers to advancing this field and recommendations for overcoming these barriers through collaborative efforts.
Repin, Mikhail; Pampou, Sergey; Karan, Charles; Brenner, David J; Garty, Guy
We demonstrate the use of high-throughput biodosimetry platforms based on commercial high-throughput/high-content screening robotic systems. The cytokinesis-block micronucleus (CBMN) assay, using only 20 μl whole blood from a fingerstick, was implemented on a PerkinElmer cell::explorer and General Electric IN Cell Analyzer 2000. On average 500 binucleated cells per sample were detected by our FluorQuantMN software. A calibration curve was generated in the radiation dose range up to 5.0 Gy using the data from 8 donors and 48,083 binucleated cells in total. The study described here demonstrates that high-throughput radiation biodosimetry is practical using current commercial high-throughput/high-content screening robotic systems, which can be readily programmed to perform and analyze robotics-optimized cytogenetic assays. Application to other commercial high-throughput/high-content screening systems beyond the ones used in this study is clearly practical. This approach will allow much wider access to high-throughput biodosimetric screening for large-scale radiological incidents than is currently available.
Enzing, C.M.; Valk, T. van der
In general the biotechnology sector can be qualified as a science driven and high tech sector. This applies for both the group of biotech start-ups that are present in each of the three sub-sectors (red biotech: health/pharma, green biotech: agrifood and white biotech: chemicals) as for the red biot
Faeh, Andrea Beata
, this autonomous interpretation of ‘human embryo’ and the flexibility allowed to the national courts needed further clarification. This clarification was recently given by the Court’s Grand Chamber in International Stem Cell Corporation v Comptroller General Patents where the Court concluded that a non...
A CAFC en banc case from 2012 holds that all of the steps of a claimed method must be performed, but it is not necessary that all steps be performed by a single entity, which are the requirements of the traditional "all-elements rule," for induced infringement to occur. An induced infringement is that an alleged infringer knowingly induces infringement and possesses intention to encourage another's infringement. In this way, even when the entity omits a part or property from the claims of an existing patent, which has been a common and successfully used practice to avoid direct patent infringement, may still be liable for induced infringement. A case study discussed in this article demonstrates this possibility. To design-around a patent, one should pay attention to the methods claims to avoid both direct and induced infringement. On the contrary, a patentee should increase the scope of the methods claims for better protection. The patent owner may thus increase the patent's power with the methods claims because not all steps of a claimed method would have to be committed by a single entity to find the induced infringement.
Several barriers limit the development of vaccines against sexually transmitted diseases (STIs). Critical scientific information is missing that makes the feasibility and the likelihood of success of vaccines against genital herpes, chlamydia, gonorrhea and trichomonas uncertain: the immunity induced by natural infection is absent or imperfect which seriously limits the capacity to define the types of immune responses that an effective vaccine must induce. Reliable animal models are lacking and a number of crucial clinical questions are still unanswered about the goal of these vaccines and definition of endpoints for clinical trials. In the absence of a clear recognition of the need for vaccines against these diseases, there is no motivation for public or private research and industry to invest in the development of vaccines against STIs. The STI burden should be evaluated not only in terms of mortality and morbidity, but also in terms of economic and psycho-social impact. A global public-private consortium could mobilize the joint efforts of all stakeholders involved in the research, development and implementation of STI vaccines of the public and private sectors; ensure that sufficient resources are applied to R&D of vaccines against these STIs; and provide the pull-push forces that are necessary to overcome the barriers to develop safe and effective vaccines against these diseases.
Herrmann, A.M.; Taks, J.L.; Moors, E.H.M.
When internal knowledge bases are insufficient for developing innovations, companies tend to collaborate with external R&D partners. According to a long-standing literature on “clusters”, “industrial districts”, “local production systems” and “regional innovation systems”, geographical proximity bet
UBOLDI, FRANCESCO MATTIA; FERRUA, PAOLO; PARENTE, ANDREA; Pasqualotto, Stefano; Berruto, Massimo
Meniscal replacement to treat early osteoarthritis of the knee after meniscectomy may be accompanied by other surgical procedures to treat factors predisposing to a negative intervention outcome. Overload of the medial compartment in slight varus can be reduced by applying the new KineSpring system, which can promote the best possible outcome of a biodegradable meniscal scaffold implantation, without producing biomechanical and anatomical alterations of the joint. This is the first case repor...
Chung, Thomas D Y
There has been increased concern that the current "blockbuster" model of drug discovery and development practiced by "Big Pharma" are unsustainable in terms of cost (> $1 billion/approved drug) and time to market (10 - 15 years). The recent mergers and acquisitions (M&A), shuttering of internal research programs, closure of "redundant" sites of operations, senior management turnover and continued workforce reductions among the top 10 major pharmaceutical companies reflect draconian responses to reduce costs. However, the resultant exodus of intellectual capital, loss in motivation and momentum, and exit from early stage discovery programs by pharmaceutical companies has contributed to an "innovation deficit". Disease advocacy groups, investment communities and the government are calling for new innovative business models to address this deficit. In particular they are looking towards academia and clinical trials centers to catalyze new innovations in translational research. Indeed over the last decade many academic institutions have launched drug discovery centers largely comprising high-throughput screening (HTS) to accelerate "translational" research. A major impetus for this "open innovation" effort has been the National Institutes of Health (NIH) "Roadmap" and Molecular Libraries Initiative/Program (MLI/MLP), which is in its last year, and will be transitioned into the National Center for the Advancement of Translational Sciences (NCATS). With the end of Roadmap funding, general reduction in Federal government funding and its recent sequestration, academic drug discovery centers are being challenged to become selfsustaining, adding financial value, while remaining aligned with the missions of their respective academic non-profit institutions. We describe herein, a brief history of our bi-coastal Conrad Prebys Center for Chemical Genomics (Prebys Center) at the Sanford|Burnham Medical Research Institute (SBMRI), the key components of its infrastructure, core competencies of its fully integrated drug discovery expertise, best practices adopted in our day-to-day operations, and finally some of our current funding and collaboration and/or strategic alliance models for pre-competitive drug discovery with other academic/clinical partners, other governmental agencies, and with pharmaceutical and biotechnology companies.
Full Text Available Abstract Background Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure. The Uganda Ministry of Health currently recommends the serial rapid testing algorithm with Determine, STAT-PAK, and Uni-Gold for diagnosis of HIV infection. Using this algorithm, individuals who test positive on Determine, negative to STAT-PAK and positive to Uni-Gold are reported as HIV positive. We conducted further testing on this subgroup of samples using qualitative DNA PCR to assess the potential for false positive tests in this situation. Results Of the 3388 individuals who were tested, 984 were HIV positive on two consecutive tests, and 29 were considered positive by a tiebreaker (positive on Determine, negative on STAT-PAK, and positive on Uni-Gold. However, when the 29 samples were further tested using qualitative DNA PCR, 14 (48.2% were HIV negative. Conclusion Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of individuals who test positive when a tiebreaker test is used in serial testing. These findings highlight a need for confirmatory testing for this category of individuals.
SantaCruz Biotech) or cyclin Dl (AB-3, Neomarker) antibody, c-Fos, c-Jun, Fra-2 and MyoD antibody ( SantaCruz Biotech Inc., USA). Figure 3. The temporal...promoter. Figure 12. Chormatin Immunoprecipitation (ChIP) assay for differentiated genuine mouse myoblast cells using MyoD antibody ( SantaCruz Biotech, SC
... from Biopure Corp. to OPK Biotech, LLC. DATES: This rule is effective January 18, 2011. FOR FURTHER... Biotech, LLC, 11 and 39 Hurley St., Cambridge, MA 02141. There is no change in drug labeler code... addition, OPK Biotech, LLC, is not currently listed in the animal drug regulations as a sponsor of...
Jarosławski, Szymon; Toumi, Mondher
Approved by the US Food and Drug Administration (FDA) in 2010, sipuleucel-T (Provenge(®)) was the first 'personalized' cancer vaccine for the treatment of prostate cancer in a metastatic, non-symptomatic population of 30,000 men in the USA. Sipuleucel-T is prepared individually for each patient and infused in three sessions over a period of 1 month. However, in 2015, Dendreon, the owner of sipuleucel-T, filed for bankruptcy. This opinion paper reviews the probable reasons this innovative product failed to achieve commercial success. PubMed and internet searches were performed focused on pricing, reimbursement, and market access. We found that sipuleucel-T's FDA approval was delayed by 3 years, reportedly because of the vaccine's new mechanism of action. Sipuleucel-T was cleared by the European Medicines Agency 2 years later, but other national agencies were not approached. It was priced at $US93,000 for a course of treatment, and this high price combined with the company's late securement of reimbursement for the vaccine by the US Centers for Medicare and Medicaid Services (CMS) resulted in another year's delay in accessing the market. Despite a positive recommendation by the National Comprehensive Cancer Network, sipuleucel-T's complex administration, high price, and uncertainty about the reimbursement status deterred doctors from prescribing the product. Furthermore, the vaccine's supply was limited during the first year of launch due to limited manufacturing capacity. In addition, two oral metastatic prostate cancer drugs with similar survival benefits reached the US market 1 and 2 years after sipuleucel-T. Also, even though Dendreon's market capitalization topped $US7.5 billion following the FDA's approval of sipuleucel-T, this value degraded gradually until the firm's bankruptcy 5 years later. We conclude that the bankruptcy of Dendreon was largely due to the delay in securing FDA approval and CMS coverage, as well as the high cost that had to be incurred by providers up-front. Licensing sipuleucel-T to a pharmaceutical company more experienced in the market access pathway may have saved the company and the product.
李亚南; 高俨; 张艳; 史磊; 许君; 郑文明
转基因生物(Genetically modified organisms,GMOs)特别是转基因作物的商品化应用在世界范围内迅猛发展,在推动农业、医药和工业等领域的飞速发展的同时也逐步吸引越来越多公众注意力,生物安全问题成为突出的争论话题.转基因作物及其产品的快速准确检测成为社会发展的急切需求,转基因技术的多样化也要求检测策略和检测技术的不断改进.系统综述针对各种作物转基因技术和转基因产品的检测策略和技术,全面比较各种技术的特点和适用范围,并对目前面临的问题和发展趋势进行分析.
Create a translational medicine knowledge repository--research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons?
Littman, Bruce H; Marincola, Francesco M
Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development.
Create a translational medicine knowledge repository - Research downsizing, mergers and increased outsourcing have reduced the depth of in-house translational medicine expertise and institutional memory at many pharmaceutical and biotech companies: how will they avoid relearning old lessons?
Marincola Francesco M
Full Text Available Abstract Pharmaceutical industry consolidation and overall research downsizing threatens the ability of companies to benefit from their previous investments in translational research as key leaders with the most knowledge of the successful use of biomarkers and translational pharmacology models are laid off or accept their severance packages. Two recently published books may help to preserve this type of knowledge but much of this type of information is not in the public domain. Here we propose the creation of a translational medicine knowledge repository where companies can submit their translational research data and access similar data from other companies in a precompetitive environment. This searchable repository would become an invaluable resource for translational scientists and drug developers that could speed and reduce the cost of new drug development.
17年间,转基因作物在全球的种植面积逐渐扩大了100倍,截止2012年已经达到1.7亿公顷,产生了巨大的经济效益、社会效益和生态效益.我国转基因作物发展迅速,目前已有7种转基因植物获得生产应用安全证书,转基因棉花占全国棉花种植面积的80％.为保障转基因生物安全,我国已建立了完整的转基因生物安全管理体系,包括安全管理机构、政策、法规,转基因生物及其产品如环境安全评价、食品安全性评价及成份测定的技术标准.另一方面,我国转基因作物安全管理及安全评价体系仍然需要完善,本文针对现阶段存在的问题提出了改进及完善的建议.同时,本文分析了我国转基因作物舆情,列举了近来国内外所谓的转基因作物安全事件并揭示了事件的真实情况,提倡理性看待转基因作物的发展,为我国转基因研发与产业化营造积极的舆论氛围.%GM crops have been commercialized for 17 years all over the world,and brought great economic,social and ecological benefits to growers and the world.China has approved 7 GM crops for planting,among which Bt cotton accounts for 80％ of cotton planting area.In this article,we reviewed development and application of GM crop internationally and domestically.The policy on GM crops in China including regulations,guidelines,food and environmental safety assessment are also briefly introduced.Some existing problems and suggestions on China's biosafety management and regulator process are also described in this review.Finally,the authors advocate rational understanding of GM crops to create a positive atmosphere for public acceptance,which will benefit research,development and commercialization of GM crops in China.
Gericke, G.S.; Simonic, I.; Cloete, E.; Buckle, C. [Univ. of Pretoria (South Africa)] [and others
Increased chromosomal breakage was found in 12 patients with DSM-IV Tourette syndrome (TS) as compared with 10 non-TS control individuals with respect to untreated, modified RPM1-, and BrdU treated lymphocyte cultures (P < 0.001 in each category). A hypothesis is proposed that a major TS gene is probably connected to genetic instability, and associated chromosomal marker sites may be indicative of the localization of secondary genes whose altered expression could be responsible for associated comorbid conditions. This concept implies that genes influencing higher brain functions may be situated at or near highly recombigenic areas allowing enhanced amplification, duplication and recombination following chromosomal strand breakage. Further studies on a larger sample size are required to confirm the findings relating to chromosomal breakage and to analyze the possible implications for a paradigmatic shift in linkage strategy for complex disorders by focusing on areas at or near unstable chromosomal marker sites. 32 refs., 1 tab.
Biotech is following big pharma to India, where R&D costs are a fraction of those in the U.S. India itself is working hard to make it happen. Ultimately, this could reduce the price of biotech therapies. But what about India's reputation for disregarding intellectual property rights?
Ben-Menachem, Gil; Ferguson, Steven M; Balakrishnan, Krishna
Young, and mid size biotech companies can benefit hugely from the US National Institutes of Health (NIH), not least because of the agency's non-dilutive funding, guidance, and opportunities for collaboration. Increasingly, however, there is a fair bit of misunderstanding about what the NIH can and cannot do for a biotech entrepreneur.
Barko, Tim; Sadler, Troy D.
The educational video game Mission Biotech provides a virtual experience for students in learning biotechnology materials and tools. This study explores the use of Mission Biotech and the associated curriculum by three high school teachers and their students. All three classes demonstrated gains on a curriculum-aligned test of science content.…
Ben-Menachem, Gil; Ferguson, Steven M; Balakrishnan, Krishna
Young biotech startups can benefit hugely from the US National Institutes of Health (NIH), not least because of the agency's non-dilutive funding, guidance, and opportunities for collaboration. Increasingly, however, there is a fair bit of misunderstanding about what the NIH can and cannot do for a biotech entrepreneur. PMID:16475248
Silk, Kami J; Weiner, Judith; Parrott, Roxanne L
Genetically modified (GM) foods are currently a controversial topic about which the lay public in the United States knows little. Formative research has demonstrated that the lay public is uncertain and concerned about GM foods. This study (N = 858) extends focus group research by using the Theory of Reasoned Action (TRA) to examine attitudes and subjective norms related to GM foods as a theoretical strategy for audience segmentation. A hierarchical cluster analysis revealed four unique audiences based on their attitude and subjective norm toward GM foods (ambivalent-biotech, antibiotech, biotech-normer, and biotech individual). Results are discussed in terms of the theoretical and practical significance for audience segmentation.
Scientific Opinion on the safety and efficacy of vitamin D3 (cholecalciferol as a feed additive for pigs, piglets, bovines, ovines, calves, equines, chickens for fattening, turkeys, other poultry, fish and other animal species or categories, based on a dossier submitted by Fermenta Biotech Ltd
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP
Full Text Available The principal physiological role of vitamin D in all vertebrates is in calcium and phosphorus homeostasis. The classic clinical deficiency syndrome is rickets. The FEEDAP Panel notes that for turkeys for fattening, equines, bovines, ovines and pigs the maximum content for vitamin D3 in feed does not provide any margin of safety, and that, except for pigs, the maximum content is above the upper safe level, according to National Research Council data when animals were fed a supplemented diet for more than 60 days. No safety concern was identified for the use of vitamin D3 in chickens for fattening and fish. The FEEDAP Panel is not in a position to draw final conclusions on the safety of vitamin D for target animals but considers the current maximum contents temporarily acceptable pending a review of the recent scientific literature. Current nutritional surveys in 14 European countries showed that vitamin D intake is sufficiently below the upper safe limit. The FEEDAP Panel assumes that foodstuffs of animal origin were produced following current production practices, including vitamin D3 supplementation of feed and concludes that the use of vitamin D in animal nutrition at the currently authorised maximum dietary content has not and will not cause the tolerable upper intake level to be exceeded. Vitamin D3 should be considered as irritant to skin and eyes, and as a skin sensitiser. Inhaled vitamin D3 is highly toxic; exposure to dust is harmful. No risk to the environment resulting from the use of vitamin D3 in animal nutrition is expected. The vitamin D3 under application is regarded as an effective dietary source of the vitamin in animal nutrition.
侯全华; 蔡辉; 刘乃齐
Biotech companies increasingly seek certification for compliance with religious and dietary requirements in order to address new consumer markets. Technology plays a crucial role in such inspections alongside centuries old traditions and practices...
It’s the hottest area of biotech drug development, with more than 100 currently in development. If mAbs make life easier for patients with devastating diseases, demand will skyrocket. Payers want want proof of their value.
Päärt, Villu, 1972-
Soome biotehnoloogiafirma FIT Biotech on loobumas kavast katsetada Eesti teadlaste leiutatud vaktsiini ka siinsete HIV-positiivsete katserühmal, sest Eestis on levinud maailmas üliharuldane HI-viiruse G-alatüüp
Friendly policies for overseas investors to invest in China＇s biofuel sector have influenced partnerships between domestic and foreign companies to develop the alternative to fossil fuel. For example, Green Biologics （GBL）, a British biotech company, has
Eesti teadusfirmadest: biotehnoloogia ettevõtted Celecure AS, Protobios OÜ, Icosagen AS, Asper Biotech AS ja Solis BioDyne OÜ, geenitehnoloogia firma Genorama OÜ, keemiatehnoloogia ettevõte AS Cambrex Tallinn
Päärt, Villu, 1972-
Vt. ka Postimees : na russkom jazõke 5. apr., lk. 2. Tartu teadlaste leiutatud ning Soome biotehnoloogiafirma FIT Biotech arendatavat vaktsiini katsetatakse Lõuna-Aafrika Vabariigis 60 surmaviirusega nakatunud inimese peal. Lisa: Eestlaste HIV-vaktsiini senine lugu
Full Text Available || time of day=ZT10 || target=NR3C1 || antibody=Mix of GR Antibody (Santa Cruz Biotech, catalog...# sc-1004) and Glucocorticoid Receptor Antibody (Thermo Scientific, catalog# PA1-511A) http://
Belt, v.d. H.; Gremmen, B.
Opponents of biotechnology ofteninvoke the Precautionary Principle to advancetheir cause, whereas biotech enthusiasts preferto appeal to ``sound science.'' Publicauthorities are still groping for a usefuldefinition. A crucial issue in this debate isthe distribution of the burden of proof amongthe pa
Full Text Available z Biotech || antibody vendorid=sc-66882 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments. || controlid
Full Text Available Cruz Biotech || antibody vendorid=sc-764 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments. || control
Full Text Available a Cruz Biotech || antibody vendorid=sc-345 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments. || contro
Full Text Available Biotech || antibody vendorid=sc-7202 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments. || controlid=wg
Full Text Available name=Santa Cruz Biotech || antibody vendorid=sc-345 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments.
Full Text Available ta Cruz Biotech || antibody vendorid=sc-1703 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments. || cont
Full Text Available e=Santa Cruz Biotech || antibody vendorid=sc-1694 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments. ||
Full Text Available Biotech || antibody vendorid=sc-866 || control=std || control description=Standard input signal for most experiments.... || control=std || control description=Standard input signal for most experiments
Full Text Available rname=Santa Cruz Biotech || antibody vendorid=sc-1694 || control=std || control description=Standard input signal for most experiment...s. || control=std || control description=Standard input signal for most experiments
Full Text Available antibody vendorname=Santa Cruz Biotech || antibody vendorid=sc-1703 || control=UCDavis || control description=Input library was prepa...red at UC Davis. || control=UCDavis || control description=Input library was prepare
Carotenoids are a class of red, orange and yellow pigments widely distributed in nature. Biotech approach has been proved to be effective in successfully engineering of carotenoid content in food crops with better health and visual appearance....
Full Text Available | cell type=CD34+CD133+ hematopoietic progenitor cells (HPCs) || antibody=anti-GABP-alpha || antibody manufacturer=Santa Cruz Biotech...nology http://dbarchive.biosciencedbc.jp/kyushu-u/hg19/e
At the turn of 21 th century, breakthroughs have been made continuously in the biology technology. That gives a great help to the quick emergence of biotech industry. Some tendencies can be seen in the industry: 1) Biotech has become the research focus in many countries. 2)Biotech industry has been the emphasis of international high-tech and economic competition.3) Biology economy is becoming a new economic growth point after Internet.4)Biology security has become the key of the state security. The emergence of biotech industry will accelerate the formation of the 4th economy upsurge and will have great effect on the world economy and the development of human society.
US Fish and Wildlife Service, Department of the Interior — The official State census period for common terns was June 1-10. The survey was conducted on June 4 by Biologist Healey, Biotech Springfield, and Maintenance...
Shanghai Outdo Biotech Co.Ltd. (Outdo Biotech) is a leading company in human/animal Tissue Microarrays (TMA) and "Clinical-Type" Gene Chip (CTGC) in China. Our shareholders are Shanghai Biochip Co., Ltd. & National Engineering Center for Biochip at Shanghai, Shanghai Cancer institute and Eastern Liver and Bladder Hospital of Second Military Medical University. TMA is a mean of combining tens to hundreds of specimens of tissue, paraffin embedded or frozen, onto a single slide for analysis at once. Our constr...
Lee, Sang Yup; Jungbauer, Alois
The latest "Biotech Methods and Advances" special issue of Biotechnology Journal continues the BTJ tradition of featuring the latest breakthroughs in biotechnology. The special issue is edited by our Editors-in-Chief, Prof. Sang Yup Lee and Prof. Alois Jungbauer and covers a wide array of topics in biotechnology, including the perennial favorite workhorses of the biotech industry, Chinese hamster ovary (CHO) cell and Escherichia coli.
Biotech companies increasingly seek certification for compliance with religious and dietary requirements in order to address new consumer markets. Technology plays a crucial role in such inspections alongside centuries old traditions and practices......Biotech companies increasingly seek certification for compliance with religious and dietary requirements in order to address new consumer markets. Technology plays a crucial role in such inspections alongside centuries old traditions and practices...
Full Text Available The paper is aimed on the problematic of biotech crops planting (GM, transgenic crops. The main aim of this paper is to analyze the trends in the main biotech crops planting groups in the sense of their use for food and feed in the future. The selected groups of biotech crops analyzed in this article are soybeans, maize (corn, cotton and rapeseed (canola. The used methods are chain and basic indexes and regression analysis of times series/ trend data - for predicting on next four years (2012-2015. The trends are able to determine the necessity of implementation the biotech crops planting into the agricultural systems everywhere (also in EU and it is without the questions if the impact are mainly positive or negative. The dependence of world agricultural commodity market on the biotech crops is undeniable and the prediction acknowledges that the importance is increasing. Pieces of knowledge introduced in this paper resulted from solution of an institutional research intention MSM 6046070906 „Economics of resources of Czech agriculture and their efficient use in frame of multifunctional agri-food systems“.
Valentin, Finn; Dahlgren, Johan Henrich; Lund Jensen, Rasmus
instead the attention to the quality of their science, or the roles of boards, management, and collaborative networks etc. Using a unique comprehensive dataset on Danish and Swedish biotech start-ups in drug discovery this paper analyzes their research strategies. Adopting a Simonean point of departure we......Although biotech start-ups fail or succeed based on their research few attempts have been made to examine if and how they strategize in this core of their activity. Popular views on Dedicated Biotech Firms (DBFs) see the inherent uncertainty of research as defying notions of strategizing, directing...... that Shonhoovens classical argument that "strategy matters" is valid not only for the larger high-tech firms covered by her study, but also for small research-based start-ups operating at the very well springs of knowledge where science directly interacts with technologies. Even though a lot more research...
Gorm Hansen, Birgitte
. Drawing on interviews with the head of a research center in plant biology, this article argues that biology and biotech are symbionts. In order to be viable and productive, symbiosis needs to be carefully managed and given room for divergence within mutual dependence. This process does not take place...... as the negotiation of a preexisting science-industry boundary. Rather, viability is obtained through a strategy of circumventing the science-industry food chain and sequestering biotech components within the research center. Symbiosis allows academic scientists to do biology while at the same time demonstrating...
Gorm Hansen, Birgitte
. Drawing on interviews with the head of a research center in plant biology, this article argues that biology and biotech are "symbionts". In order to be viable and productive, symbiosis needs to be carefully managed and given room for divergence within mutual dependence. This process does not take place...... as the negotiation of a preexisting science-industry boundary. Rather, viability is obtained through a strategy of "circumventing" the science-industry food chain and "sequestering" biotech components within the research center. Symbiosis allows academic scientists to do biology while at the same time demonstrating...
Søberg, Peder Veng; Harryson, Sigvald
, which triggered unexpected reverse knowledge transfer with immediate impact on innovation performance in distribution equipment. By contrast, Biotech did not co-operate as closely with local universities as Packtech did. In spite of this, Biotech managed to some extent to live up to its objectives...... is that Windtech took a more open collaboration approach towards other local companies – typically R&D Centers of Western leading companies in relevant industries. This open recruiting policy provided the platform for locally created innovations with global innovation impact....
Viani, Rolando M; Araneta, Maria Rosario G; Spector, Stephen A
The objectives of this study were to evaluate the performance of parallel rapid HIV testing and the presence of HIV-associated risk factors in pregnant women with unknown HIV status in Baja California, Mexico. Pregnant women attending the delivery unit or the prenatal clinic at Tijuana General Hospital had blood drawn for parallel rapid HIV testing with Determine™ HIV-1/2 and Uni-Gold™ Recombigen(®) HIV. The parallel rapid HIV test performance was compared to the enzyme immunoassay (EIA) and western blot. From September 2007 to July 2008, 1,383 (94%) of 1,464 women in labor and 1,992 (96%) of 2,075 women in prenatal care were enrolled. The HIV seroprevalence among women screened during labor (19/1,383, 1.37%, 95% CI: 0.85-2.18%) was significantly higher compared to those seeking prenatal care (5/1,992, 0.25%, 95% CI: 0.09-0.62%; pwomen testing positive by parallel rapid HIV testing 24 had a positive confirmatory western blot and one (0.03%) was confirmed as false positive. Additionally, two (0.06%) women had parallel rapid HIV discordant testing results; both tested negative by western blot. All women who tested negative by rapid testing had negative results on pooled EIA antibody testing. The overall sensitivity, specificity, and positive and negative predictive values of parallel rapid HIV testing were 100%, 99.9%, 96%, and 100%, respectively. These findings document a very high acceptance rate and an excellent performance of the parallel rapid HIV testing strategy during pregnancy.
Full Text Available nology http://dbarchive.biosciencedbc.jp/kyushu-u/mm9/ea...IH3T3_MRTFB_LAT || cell line=NIH3T3 fibroblasts || genotype=normal || chip antibody=MRTF-B || chip antibody vendor=Santa Cruz Biotech
Full Text Available Serum response transcription factor || antibody vendorname=Santa Cruz Biotechnology || antibody vendorid=sc-335 || protocol...z Biotech || antibody vendorid=sc-335 || treatment=None || treatment description=No special treatment or protocol applies || protocol...=PCR1x || protocol description=1-cycle of PCR (Myers) ||
Full Text Available racting with HDAC1, N-coR, SMRT, and MeCP2 || antibody vendorname=Santa Cruz Biotechnology || antibody vendorid=sc-994 || protocol...orname=Santa Cruz Biotech || antibody vendorid=sc-994 || treatment=None || treatment description=No special treatment or protocol... applies || protocol=PCR1x || protocol description=1-cycle o
Full Text Available ntibody targetdescription=EP300(c-20) || antibody vendorname=Santa Cruz Biotechnology || antibody vendorid=sc-585 || protocol...rname=Santa Cruz Biotech || antibody vendorid=sc-585 || treatment=None || treatment description=No special treatment or protocol... applies || protocol=PCR1x || protocol description=1-cycle of PCR (Myers) || controlid=S
Full Text Available O-binding site (KBS) TCCTGCNA || antibody vendorname=Santa Cruz Biotechnology || antibody vendorid=sc-23871 || protocol...endorname=Santa Cruz Biotech || antibody vendorid=sc-23871 || treatment=None || treatment description=No special treatment or protoco...l applies || protocol=PCR1x || protocol description=1-cycle of PCR (Myers) || contr
Full Text Available 50kDa. Also designated TAF250. || antibody vendorname=Santa Cruz Biotechnology || antibody vendorid=sc-735 || protocol...Santa Cruz Biotech || antibody vendorid=sc-735 || treatment=None || treatment description=No special treatment or protocol... applies || protocol=PCR1x || protocol description=1-cycle of PCR (
”. In contrast to previous findings, however, the results show that large-volume applicants are more likely to be opposed. Because the boundaries of plant biotech patents are ill-defined, large patent portfolios do not promote cooperative behavior such as licensing or settlements. The analysis rejects...
Rossum, van T.; Kengen, S.W.M.; Oost, van der J.
The biotech industry is continuously seeking for new or improved biocatalysts. The success of these efforts is often hampered by the lack of an efficient screening assay. Thus, to be able to extend the number of enzymes available for industrial applications, high-throughput screening and selection m
Soome kontsern Vapo ostis ASi Tootsi Turvas enamusaktsiad. Soome ettevõte Fit Biotech ostis Tartu biotehnoloogiaettevõtte Quattromed ja Soome toiduainetetööstuse ettevõte Saarioinen Oy Eesti tütarfirma omandas üle 66-protsendilise osaluse valmistoidufirmas Meleco AS
Rozental, Väinu, 1957-
Geenivaramu lepingusüsteem mängib geenianalüüsi tegemisel suured trumbid kätte geenivaramu eestvedajate Jaanus Pikani ja Andres Metspalu osalusega Tartus geenianalüüsiga tegelevale AS-ile Asper Biotech
Eesti biotehnoloogiafirma Icosagen hakkab koos Soome ettevõtte FIT Biotech Oy'ga välja töötama Ebola viiruse vastast vaktsiini, arendustöös osaleb professor Andres Meritsa juhtimisel ka Tartu Ülikooli Tehnoloogiainstituudi rakendusviroloogia labor. Vestlusest Tartu Ülikooli biomeditsiinitehnoloogia professori Mart Ustaviga
Talviste, Kaire, 1979-
Molekulaarbioloog Mart Ustavi tööst bioloogiliste ravimite väljatöötamisel. HIV1/AIDS vaktsiini väljatöötamisest FIT Biotech Oy Eesti filiaalis a-tel 2000-2011. M. Ustavi biotehnoloogia firma Icosagen Grupp tehnoloogilistest arendustest
Jõgi, Aime, 1958-
Eesti biotehnoloogiafirma Icosagen hakkab koos Soome ettevõtte FIT Biotech Oy'ga välja töötama Ebola viiruse vastast vaktsiini, arendustöös osaleb ka Tartu Ülikooli Tehnoloogiainstituudi rakendusviroloogia labor
The search for an AIDS (acquired immune deficiency syndrome) vaccine is truly a global effort, with university laboratories, biotech firms, pharmaceutical companies, nonprofit research organizations, hospitals, and clinics all working together to develop an effective vaccine as quickly as possible. The International AIDS Vaccine Initiative (IAVI)…
Full Text Available Cruz Biotech || antibody vendorid=sc-197 || control=Control_50bp || control description=This data represents a control being compare...on=Immortal cells || control=Control_50bp || control description=This data represents a control being compare
Joshi, Kirti; Mehra, Kavita; Govil, Suman; Singh, Nitu
Among the developing countries, India is one of those that recognises the importance of biotechnology. The trajectory of different policies being formulated over time is proof that the government is progressing towards achieving self-sufficiency. However, to cater to the ever-growing biotech industry, skilled manpower is required. This article…
by Bio-Tech, Inc., the New Mexico Lung Association, and the Maria Teresa Restaurant was also most helpful. We are also indebted to individuals who...pH was somehow better regulated than was blood pH. Kellogg introduced us to the White Mountain Laboratory, east of the Sierras , which was built in
Eastwood, Jennifer L.; Sadler, Troy D.
Research in education suggests that computer games can serve as powerful learning environments, however, teachers perceive many obstacles to using games as teaching tools. In this study, we examine three science teachers' implementation and perceptions of a curriculum unit incorporating the game, Mission Biotech (MBt) and a set of supporting…
Curran, Kassie L; Festa, Adam R; Goddard, Scott D; Harrigan, George G; Taylor, Mary L
Monsanto Co. has developed two sweet corn hybrids, MON 88017 and MON 89034, that contain biotechnology-derived (biotech) traits designed to enhance sustainability and improve agronomic practices. MON 88017 confers benefits of glyphosate tolerance and protection against corn rootworm. MON 89034 provides protection against European corn borer and other lepidopteran insect pests. The purpose of this assessment was to compare the kernel compositions of MON 88017 and MON 89034 sweet corn with that of a conventional control that has a genetic background similar to the biotech sweet corn but does not express the biotechnology-derived traits. The sweet corn samples were grown at five replicated sites in the United States during the 2010 growing season and the conventional hybrid and 17 reference hybrids were grown concurrently to provide an estimate of natural variability for all assessed components. The compositional analysis included proximates, fibers, amino acids, sugars, vitamins, minerals, and selected metabolites. Results highlighted that MON 88017 and MON 89034 sweet corns were compositionally equivalent to the conventional control and that levels of the components essential to the desired properties of sweet corn, such as sugars and vitamins, were more affected by growing environment than the biotech traits. In summary, the benefits of biotech traits can be incorporated into sweet corn with no adverse effects on nutritional quality.
Since the late 1990s, when massive backlash against genetically modified organisms emerged worldwide, the mainstream political economic powers, i.e., the US government and transnational biotech companies, have been actively and deliberately engaged in the discourse of biotechnology for the poor to c
Full Text Available eric_male || labversion=baseAlignCounts.pl v 1,p-value cutoff: 0.01,fseq v 1.84, iff_generic...ta Cruz Biotech || antibody vendorid=sc-764 || controlid=generic_male || labversion=align_on_cluster_bwa.pl ...astic disease || antibody vendorname=Santa Cruz Biotechnology || antibody vendorid=sc-764 || controlid=gen
Päärt, Villu, 1972-
Ülemaailmses HIV- andmebaasis on registreerimisel HI-viiruse alatüüp, mida on seni avastatud ainult Eestis. Mosaiik-HIV on segu peamiselt Aafrikas esinevast viiruse vormist ning Ukrainas levinud tüübist, selgub biotehnoloogiafirma FIT Biotech uuringust. Kommenteerib Tartu Ülikooli tehnoloogiainstituudi direktor Mart Ustav
Graul, A I; Cruces, E; Stringer, M
Nearly 100 new drugs and biologics, including important new line extensions, were approved or launched for the first time globally in 2015. These products are covered in depth in part I of our annual review of the pharma and biotech industry.
Besides characteristic high target affinity, biological peptides often exhibit higher than expected stability. Clearly natural selective pressure has optimised these biomolecules beyond what can be anticipated solely on the basis of their chemical nature. This concept is gradually finding its way into the pharma and biotech industry, as illustrated by a rise in medicinal peptide patent applications and developmental work.
OMTA, SWF; BOUTER, LM; VANENGELEN, JML
In this paper management control is related to innovative and industrial performance in 14 non-biotech pharmaceutical companies. The study consisted of questionnaires, sent to the heads of the different research departments of European research laboratories of leading pharmaceutical companies, combi
Biotech engineering of agronomic traits requires an array of highly specific and tightly regulated promoters in flower or other tissues. In this study, we isolated and characterized two tobacco AP1-like promoters (termed NtAP1La and NtAP1Lb1) in transgenic plants using GUS reporter and tissue-speci...
This paper reports on work in progress. We present work on domain specific verbs and their role as relations in domain ontologies. The domain ontology which is in focus for our research is modeled in cooperation with the Danish biotech company Novo Nordic. Two of the main purposes of domain...
American Association of Community Colleges (NJ1), 2004
This edition of "TECHcitement" contains the following articles: (1) ATE Program Leads to Student Success; (2) Doing Whatever It Takes for Aquaculture; (3) The Bridge to Biotech; (4) Girls See What They Can Do With Technology at Camp; (5) Students Advancing Solutions to Business Problems; (6) CREATE Recreates Technical Education in California; (7)…
quantum dots," Nat Biotech, vol. 22, pp. 969-976, 2004.  D. A. Hall, J. Ptacek, and M. Snyder, "Protein microarray technology," Mechanisms of... Shankar , and R. Mutharasan, "A review of fiber-optic biosensors," Sensors and Actuators B: Chemical, vol. 125, pp. 688-703, 2007.  G. Proll, L
bioplastic -producing "Knallgas" bacterium Ralstonia eutropha HI6. Nature Biotechnology. 73. Pohlmann, A., W. F. Fricke, F. Reinecke, B. Kusian, H...2006. Genome sequence of the bioplastic -producing "Knallgas" bacterium Ralstonia eutropha HI6. Nature Biotech. 74. Pruesse, E., C. Quast, K. Knittel
Kinchy, Abby J.; Kleinman, Daniel Lee; Autry, Robyn
This study challenges the assumption that abstract "globalization" forces are driving transformations in the relationships between states and markets. Employing three cases of policy debate regarding the regulation of agricultural biotechnology (ag-biotech), we examine the role of discourse in the formation of neoliberal regulatory schemes. We…
Kossmann, J.; Jakobsen, Iver; Nielsen, K.K.;
In 2003 the Plant Research Department (PRD) at Risø National Laboratory was involved in establishing the consortium Plant Biotech Denmark, which is unifying most of the Danish Plant Biotechnology activities. Within the consortium, PRD has the uniqueopportunity to be the only life science department...
denitrifying biotech propellants & explosives aliphatic nitro- products compounds BIOMATERIALS " Fibers Cloned synthesis fibers - Solid state synthesis - High... solid state synthesis " Elastomers • Producers identified * Production optimization * Gaskets, coatings ° Polymer characterization * Material...optimization " Cloned synthesis - Solid state synthesis • Adhesives * Cloned variants - Cloned synthesis * General use adhesive Product variants -Variants
Liang, C.; Dijk, van J.P.; Scholtens, I.M.J.; Staats, M.; Prins, T.W.; Voorhuijzen, M.M.; Silva, A.M.; Maisonnave Arisi, A.C.; Dunnen, den J.T.; Kok, E.J.
The growing number of biotech crops with novel genetic elements increasingly complicates the detection of genetically modified organisms (GMOs) in food and feed samples using conventional screening methods. Unauthorized GMOs (UGMOs) in food and feed are currently identified through combining GMO ele
Upadrasta A; Madempudi RS
Aditya Upadrasta, Ratna Sudha Madempudi Centre for Research and Development, Unique Biotech Limited, Alexandria Knowledge Park, Shamirpet, Hyderabad, India Abstract: Gut microbiota play a significant role in host metabolic processes, and recent metagenomic surveys have revealed that they are involved in host immune modulation and influence host development and physiology (organ development). Initially, probiotics are identified as potential therapeutics to treat gastrointestinal disorders an...
Arakawa and Gins are concerned with the bio-tech creatures we have become – or perhaps the ones we have always been. They see us as creatures-witharchitecture, architecture being for them, and along with language, one of the most basic forms of technique. Their ‘architectural body’ is constitutive o
Twardowski, Tomasz; Małyska, Aleksandra
The EU has a complicated regulatory framework, and this is slowing down the approval process of new genetically modified (GM) crops. Currently, labeling of GM organisms (GMOs) is mandatory in all Member States. However, the USA, in which GMO labeling is not mandatory, continues to lead the production of biotech crops, biopharmaceuticals, biomaterials, and bioenergy.
This thesis aimed to explore eukaryotic cellular processes upon the virulent attack of low doses of a well-known pore forming toxin (staphylococcal α-hemolysin (αHL)) and to develop a new biotech application using the same protein.
This report presents a picture of European opinion on farm animal cloning. In the report, both agricultural and biomedical applications of farm animal cloning are considered. With the arrival of Dolly, animal cloning became an integral part of the biotech debate, but this debate did not isolate...
This chapter is an investigation into the internationalization of innovation in the Danish food-related biotech industry. The process of the internationalization of innovation in food and ingredients into new markets has followed a similar path: first, the companies enter new markets with their p...
Contract research organizations have quietly and quickly become a force in drug development and clinical trial recruitment. In supplanting academia as the primary route to market, they have the kind of business plan and agility that only a biotech could love.
to the Pacific theater, b) growing boldness of Russia , c) continued development of North Korea’s nuclear/missile programs d) Iranian nuclear...pdf; Biotechnology : www.governor.state.tx.us/files/ecodev/Biotech_Report.pdf 10 The installations in the state are vital to national security and
....nytimes.com/2013/01/29/business/battle-in-states-on-generic-copies-of-biotech-drugs.html?_r=0 . \\7\\ See... explained, raises ethical concerns associated with unnecessary human testing.'' Fed. Trade Comm'n, Emerging...), available at http://step.berkeley.edu/Journal_Club/paper2_110309.pdf . Indeed, `` mall changes in...
Full Text Available IH3T3_MRTFA_LAT || cell line=NIH3T3 fibroblasts || genotype=normal || chip antibody=MRTF-A || chip antibody vendor=Santa Cruz Biotech...nology http://dbarchive.biosciencedbc.jp/kyushu-u/mm9/ea
... for termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug... each package. The pills were in blister packs on which was written ``Omega Biotech LTD.'' Mr. Freeman... Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability...
... termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... blister packs on which was written ``Omega Biotech LTD.'' Mr. Foyle and his co-defendant, David Freeman... the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in...
Full Text Available treatment description=1 h with 0.02% Dimethyl sufloxide (DMSO) (Myers) || controlid=SL1882 || labexpid=SL208...uz Biotech || antibody vendorid=sc-6553 || treatment=DMSO_0.02pct || treatment description=1 h with 0.02% DMSO (Myers...one 15-cycle round of PCR (Myers) || controlid=SL1882 || labexpid=SL1880 || repli
Gretton, Linda Burak
The current pharmaceutical industry, whose origins date from the early 20th century, and the biotechnology industry, which emerged in the 1980s both have foundations built on the modern scientific method and share a mission to develop new drugs for humans and animals. At the same time, they are also made distinct by size (small biotechs versus…
@@ A new city is in the making on the eastern outskirts of Guangzhou.In lieu of the average citizen,the city will be home to thousands of biotech engineers or new energy researchers.It will be a green city.It will be a hi-tech city.It will be a city of the future.
Root-knot nematodes (RKNs) infect many annual and perennial crops and are the most devastating soil-born pests in vineyards. To develop a biotech-based solution for controlling RKNs in grapes, we evaluated the efficacy of plant-derived RNA interference (RNAi) silencing of a conserved RKN effector ge...
To develop a biotech-based solution for controlling Root-knot nematodes (RKNs) in grapes, we evaluated the efficacy of plant-derived RNA interference (RNAi) silencing of a conserved RKN effector gene, 16D10, for nematode resistance in transgenic grape hairy roots. Two hairpin-based silencing constru...
Full Text Available nsferase that promotes transcription. CBP is recruited by a variety of transcription factors to promoters and enhancers... histone acetyl transferase that promotes transcription. CBP is recruited by a variety of transcription factors to promoters and enha...ncers. || antibody vendorname=Santa Cruz Biotech || antibody vendorid=sc369 || trea
This report presents a picture of European opinion on farm animal cloning. In the report, both agricultural and biomedical applications of farm animal cloning are considered. With the arrival of Dolly, animal cloning became an integral part of the biotech debate, but this debate did not isolate...... animal cloning as a single issue....
died prematurely, all with bladder/kidney infections that we were unable to effectively treat with antibiotic . We replaced 2 of these but the third...080 or #B/\\F377. Aliquot and store at -70°C or colder. Streptavidin HRP. Supplied by Southern Biotech# 7100-05. Store at 2-8°C. Bovine Serum Albumin
The synergy between nanotech, biotech and optics is spawning the emerging field of nanobiophotonics.Optics already hurdle the diffraction barrier for imaging with nanoscopic resolutions as celebrated by the Nobel Prize 2014 in Chemistry. However, scientifi c hypothesis testing demands tools, not ...
Jones, Mark Peter
The author presents an historical account of scientific work conducted at a commercial biotech firm in San Diego called Hybritech. It tells of disruptions in research programs following the acquisition of the company by the pharmaceutical giant Eli Lilly in 1986. The story centers on responses to an organizational challenge that research managers…
discussion of research trends. KEYWORDS: Advanced Materials, Biotechnology / Biotech, Carbon Nanotubes / CNT, Consumer Electronics, Displays...Education, Electronics / Semiconductors, Energy / Power / Natural Resources, Government S&T Policy / Funding, Manufacturing, Modeling / Simulation, MEMS...area of high-cold region in the world. Rapid changes in the components of the cryosphere have profound influences on the energy balance, atmospheric
B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)
textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss ima
Full Text Available nologies http://dbarchive.biosciencedbc.jp/kyushu-u/mm9/...riment type=PPARG ChIP-seq || strain=N/A || tissue=NA || chip antibody=anti-PPAR? antibody || chip antibody vendor=Santa Cruz Biotech
邓心安; 封颖; 曾海燕
生命科学与生物技术的发展推动了"生物经济"概念的形成与生物经济时代的来临,进而导致农业、健康医疗、环保、工业制造等产业的生产与消费方式正在发生深刻变革.分别从生物经济对未来农业、健康医疗、环保及制造业的影响进行分析,提出了生物经济成长(GREW)战略.作为一个战略体系,GREW战略包括相互交叉、相互依存与影响的四个子战略:新型农业(Green biotech based)战略、健康医疗(Red biotech based)战略、绿色环保(Grey or Environmental biotech based)战略,以及绿色制造业(White biotech based)战略.GREW战略的及时提出与逐步形成,对于生物产业发展规划及政策制定具有高度前瞻性意义和指导作用.
Biotech,electron,nano technology and coginitive science are seen as four mainstreams as well as the leading trend of the development in future science and technology and the relaged industries.Biotech industry is in the red globally but the most popular field,enjoying the largest amount of investment among the four above industries,which possibly indicates high technology's advantage.China biotech industry starts up is 1980s and cover a number of fields like agriculture.medication and food.Though lage in start and far lagged behind US in its industry scale,it is growing considerable.From 1985 to 2000,its sales has increased by 75.9 times with annual growth of 33.58%.In 2000,China biotech industry has reached over RMB 20 billion yuan porduct.Gene engineering pharmacy industry is ,in particular,growing remarkably.In 1996,the sales of gene engineering medicine and bacterin was RMB 220 million yuan and in 2000.it has to RMB 2.28 billion.With a year-on-year growth of 79.42%.And its annual growth rate has since then always maintained above 20%.
Weiss, Johanna V
The intent of this project was to expand Northern Virginia Community College's capability to offer training to support the Biotechnology Industry in the northern Virginia region. The general goal of this project was to create a College Biotechnology Program; specific goals of the project were to a) design curricula/courses to prepare students to become entry-level lab technicians, b) redesign and equip lab space to better suit the needs of the program, c) develop partnerships with the local industry through outreach and the formation on an advisory board, d) recruit students into the program, and e) provide instructional support for local high school teachers. At the end of the grant period, NOVA has successfully created two new curricula in biotechnology: an Associate of Applied Science (A.A.S.) in Biotechnology (initiated in Fall 2008) and a Career Studies Certificate for Biotechnology Lab Technicians (to be initiated in Fall 2010). These curricula were designed with advice from an external advisory committee which is comprised of representatives from industry, transfer institutions and high school administrators. To date, almost all courses have been designed and piloted; the equipment needed for the courses and the initial supplies were paid for by the grant as was the re-modeling of some lab space to be used for the biotech courses. In order to market the program, the NOVA Biotech Program has also established relationships with the local high schools. Presentations were given at several local high schools and on-site workshops were held for high school students and teachers. As a result, close to 1000 students have attended program open houses, presentations within the high schools, or workshops held in the summer. Over 100 teachers have received information and/or training in biotechnology. These outreach efforts as well as high quality curricula have started to attract a number of students to the program – for example, there are currently 70 students
Full Text Available Background: Non-cold chain-dependent HIV rapid testing has been adopted in many resource-constrained nations as a strategy for reaching out to populations. HIV rapid test kits (RTKs have the advantage of ease of use, low operational cost and short turnaround times. Before 2005, different RTKs had been used in Nigeria without formal evaluation. Between 2005 and 2007, a study was conducted to formally evaluate a number of RTKs and construct HIV testing algorithms. Objectives: The objectives of this study were to assess and select HIV RTKs and develop national testing algorithms. Method: Nine RTKs were evaluated using 528 well-characterised plasma samples. These comprised 198 HIV-positive specimens (37.5% and 330 HIV-negative specimens (62.5%, collected nationally. Sensitivity and specificity were calculated with 95% confidence intervals for all nine RTKs singly and for serial and parallel combinations of six RTKs; and relative costs were estimated. Results: Six of the nine RTKs met the selection criteria, including minimum sensitivity and specificity (both ≥ 99.0% requirements. There were no significant differences in sensitivities or specificities of RTKs in the serial and parallel algorithms, but the cost of RTKs in parallel algorithms was twice that in serial algorithms. Consequently, three serial algorithms, comprising four test kits (BundiTM, DetermineTM, Stat-Pak® and Uni-GoldTM with 100.0% sensitivity and 99.1% – 100.0% specificity, were recommended and adopted as national interim testing algorithms in 2007. Conclusion: This evaluation provides the first evidence for reliable combinations of RTKs for HIV testing in Nigeria. However, these RTKs need further evaluation in the field (Phase II to re-validate their performance.
Young, Jamey D
Identifying host cell metabolic phenotypes that promote high recombinant protein titer is a major goal of the biotech industry. (13)C metabolic flux analysis (MFA) provides a rigorous approach to quantify these metabolic phenotypes by applying isotope tracers to map the flow of carbon through intracellular metabolic pathways. Recent advances in tracer theory and measurements are enabling more information to be extracted from (13)C labeling experiments. Sustained development of publicly available software tools and standardization of experimental workflows is simultaneously encouraging increased adoption of (13)C MFA within the biotech research community. A number of recent (13)C MFA studies have identified increased citric acid cycle and pentose phosphate pathway fluxes as consistent markers of high recombinant protein expression, both in mammalian and microbial hosts. Further work is needed to determine whether redirecting flux into these pathways can effectively enhance protein titers while maintaining acceptable glycan profiles.
Although the global area of biotech crops continues to climb for the tenth consecutive year at a sustainable double-digit growth rate, the acceptance of biotech products from agriculture in Europe is still low. There is a gap between science and perception. It is a strong belief that the public turning against science and against GM food has been encouraged by the negative activities of NGO groups. Scientists have to overcome the purely risk-based discussion, and the benefits of plant biotechnology have to be made literally visible. GM food should be available, the benefits should be tangible and the consumer should have fun with such novel food. The gap could be reduced if genetically modified plants and the products thereof were regulated in the same way as classical products.
From the point of macroscopical ecosystem,matching with the application of biotech the biology agrochemicals-especially focusing on the biology antisetics.pesticides and microorganism fertilizers which are used in farm crops and their seeding are developed.At the same time.combining with the construction of the large scale seeding cultivating center and the planning of the ecosystem farm,a natural organic pest-free agricultural environment is constructed.From the aspects of technology ,fund,knowledge and management,the competition capability of agriculture products is developed to the best.Besides the visible products such as biology agrochemicals ,microorganism fertilizers,seeding,farm corps,etc.,the "microorganism organism agriculture method" is configured to provide peasants with the usage system of biotech products,the blue print of "green agriculture"is gradually constructed ,the competiton capability is enhanced and finally,high rewards are out.
Bairamashvili, Dmitrij I; Rabinovich, Mikhail L
Trends in the Russian pharmaceutical biotechnology and related fields representing the major sector of domestic biotech are reviewed through the prism of the world biopharmaceuticals market. A special emphasis is placed on biogenerics and follow-on biologics. The revival of national pharmbiotech is seen in close cooperation between private companies and the state, academia and industry. One of the first positive steps toward promoting development of domestic biopharmaceuticals is the Federal Program of subsidized supply of expensive pharmaceuticals (Dopolnitel'- noe Lekarstvennoe Obespechenie). The program allows the Russian government to purchases expensive drugs to be provided free of cost to certain preferential categories of individuals. As an example, production of recombinant human insulin by the largest Russian fundamental biotechnological institute, Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry under the trademark Insuran (Insulin produced by the Russian Academy of Science) is reviewed. Some prospects and problems of Russian biotech research related to medical area are briefly discussed.
Mary Luz Yaya-Lancheros
Full Text Available Intellectual property rights have led to stimulating innovation in different fields such as biotechnology. Patents, plant variety protection, industrial secrets and material transfer agreements are legal terms individually and/or collectively protecting materials or processes deemed necessary for agricultural-biotech product development. Such terms may often accumulate to such an extent that this hinders a product’s development and commercial release. Some current initiatives are aimed at facilitating access to basic technology for agricultural-biotech product development, including public organisation cooperation networks, requests for special licences for humanitarian programmes and open access projects. These may be good short-and medium-term alternatives for carrying out biotechnological research in countries like Colombia.
This paper examines the "biotechnology problem" in the history of molecular biology, namely the alleged reinvention of a basic academic discipline looking for the logic of life, into a typical technoscientific enterprise, closely related to agriculture, medicine, and the construction of markets. The dominant STS model sees the roots of this shift in a radical change of the regime of knowledge production. The paper argues that this scheme needs to be historicized to take into account the past in our biotech present. Looking at the development of breast cancer genetic testing and GMOs as examples of mounting issues of intellectual property, risk and regulation, the paper also argues that historians of biology should pay closer attention to the political, the economical and the legal changes of the last thirty years. Solving the biotech problem requires new categories. The notion of "way of regulating" is given as an example of such notions linking the local and the global.
Guilherme Fowler de Avila Monteiro
Full Text Available This paper examines the governance of property rights on genetically modified (GM soybean seeds. Specifically, the article undertakes a comparative analysis on the collection of royalties in GM soybean seeds in the U.S. and Brazil. For each country, the authors describe the regulatory framework governing the protection of biotechnology innovations in agriculture and investigate the mechanisms of royalty collection in GM soybean seeds. The paper also offers econometric evidence linking the capture of value on biotech innovations and the protection mechanisms deployed by biotech firms. The results suggest that, subject to the institutional environment, firms may choose to transact a GM attribute separated from the seed, building specialized governance structures framed around the genetic attribute and not around the seed as a whole.
Daniel Weinacker; Claudia Rabert; Andrea B. Zepeda; Figueroa, Carolina A.; Adalberto Pessoa; Farías,Jorge G.
Since the 1970s, the establishment and development of the biotech industry has improved exponentially, allowing the commercial production of biopharmaceutical proteins. Nowadays, new recombinant protein production is considered a multibillion-dollar market, in which about 25% of commercial pharmaceuticals are biopharmaceuticals. But to achieve a competitive production process is not an easy task. Any production process has to be highly productive, efficient and economic. Despite that the perf...
Benjamin Rymzo; Nathan Dowden; Regina Salvat; Tom Lee
The overview: In recent years, the South Korean economy has evolved from light goods, to heavy industry, to high tech and biotech. Along the way, the country has built a thoroughly modern legal and regulatory framework, an arguably world class educational infrastructure, and an unusually productive level of public-private partnership activity. How did it get here?: Migrating from a heavy manufacturing economy in the aftermath of the Korean War, South Korea began turning its attention to bioph...
Vt. ka Linnaleht : Tallinn : na russkom jazõke 28. sept., lk. 4. Biotehnoloogiaettevõte Asper Biotech alustas Valgamaal kogutud DNA-proovide analüüsimist kahe kõige enam levinud päriliku vähi - rinnavähi ja jämesoolevähi - suhtes spetsiaalselt selle uuringu jaoks Eesti biokeskuses väljatöötatud ja maailmas unikaalse geenikiibi abil
With the increasing amounts of clinical data required for drug regulatory approval and the fierce competition for patients in the Western countries, the cost of clinical trials continues to rise considerably. This study suggests that outsourcing clinical trials to China is an effective strategy to reduce cost and cycle time of drug development. China offers a high market potential and strong research capacity that can provide long term benefits to pharmaceutical and biotech companies. An inte...
Ashish Arora; Alfonso Gambardella; Laura Magazzini; Fabio Pammolli
This paper compares the innovation performance of established pharmaceutical firms and biotech companies, controlling for differences in the scale and scope of research. We develop a structural model to analyze more than 3,000 drug research and development projects advanced to preclinical and clinical trials in the United States between 1980 and 1994. Key to our approach is careful attention to the issue of selection. Firms choose which compounds to advance into clinical trials. This choice d...
Biotech industry is characterized by unique elements as the companies operate in high risk environment attempting to accomplish scientific developments trough lengthy and expensive R&D cycles while facing insufficient funding. Most companies develop new drugs while not generating any revenue, however, the need for funding is critical at each stage of the new drug development process. The overall purpose of this study is to describe the challenges in new drug development and identify main sour...
into it. What he did was import a toxin from another much less grievous Bacillus strain, some hemolysin from Bacillus cereus , so it is called...toxins that begin circulating through the body, causing bacteremia , septicemia, and death. But the time frame is very unique. The time frame - 22...biotech decides to do some genetic engineering with Bacillus anthrax in a Russian laboratory, to his credit it is a published article. And what does
potential of Iraqi fermenters and other bioprocess equipment. pathogens and toxins is dual-use and widely available on the international market. One...take place naturally. Thanks to advances in biotech- nology, including improved fermentation equip- ment as well as genetic engineering techniques...signatures could be concealed or masked by legitimate activities such as biopesticide R&D or use. Production and storage of components for BW munitions
crops, we can use fermentation and chemistry to make hundreds of products including: • Alcohols, such as ethanol, glycols, and sorbitol. Ethanol is...biotech Plant Pesticides http://www.epa.gov/pesticides/ biopesticides Extramural Research and Development http://www.epa.gov/AthensR/extrmural/index.html...C2H5OH: a colorless liquid that is the product of fermentation used in alcoholic beverages, industrial processes, and as a fuel additive. Also known as
Health Risk Assessment of Women in Submarines (Phase III): Two Generation Developmental and Reproductive Safety Evaluation of Major Submarine Atmosphere Components (CO, CO2, and O2) in Rats (Rattus norvegicus)
flow monitors was connected to a four- channel power supply (Model THPS-400-115, Teledyne- Hastings Instruments, Pittsburgh, PA). The inlet air flow...connected to a four- channel power supply (Model THPS-400-115, Teledyne-Hastings Instruments, Pittsburgh PA) and manually adjusted to the appropriate...Stimulating Hormone and Luteinizing Hormone (Shibayagi Co. Ltd, Ishihara, Japan), and for vitamin D (Cusabio Biotech Co., Ltd, Newark, DE), or with a Multi
Letters. 4, 1501-1506. Mehta K, Linderman JJ, 2006: Model-based analysis and design of microchannel reactor for tissue engineering. Biotech. Bioeng. 94...system to enable robust incorporation of cells in 3-D environments using microchannels incorporating porous membranes and hydrogels, portable, long...in the reactor were quantified in real time using fluorescence intensity and lifetime imaging of an oxygen sensitive dye (Sud, et al., 2006). In
Relenza could continue to be sold and used, whereas hospitals were instructed to destroy any unused Peramivir. 17 75 Fed. Reg. 20441-20480, April...for Biodefense Biotechs,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, vol. 8, no. 4 (2010), pp. 365-372. 58 U.S...Flexible Defenses Roundtable Meeting: Promoting the Strategic Innovation of Medical Countermeasures,” Biosecurity and Bioterrorism: Biodefense Strategy
Quantum dots (QDs) have received more and more attention as a novel example of nanomaterials. Due to their unique fluorescent characteristics,quantum dots have been successfully applied in biotech-nology and medicine applications. Recently,the toxicity and the potential environmental effects of QDs have become a research hotspot. In this paper,toxicological effects of QDs are reviewed,and the prospects and research directions are given based on the analysis of this research field.
fermentation in the cyanobacterium Arthrospira ( Spirulina ) maxima CS-328. Appl. Environ. Microbiol., 77: 7185-7194. 5. Zhang, S. and Bryant, D. A...Biotech. Biofuels. 7: 154. 13. Zhang, S. and Bryant, D. A. 2014. Learning new tricks from an old cycle: the TCA cycle of cyanobacteria, algae and...energy conservation during fermentation in the cyanobacterium Arthrospira ( Spirulina ) maxima CS-328. Appl. Environ. Microbiol., 77: 7185-7194. 5
Ratcliffe, L T
Small biotech companies have been an important source of innovation, pipelines, and new products for the pharmaceutical industry, and are primarily financed by venture capital (VC). The significant changes happening within the VC industry have broad implications for these small companies. This includes a shift to financing later-stage programs with increasing interest in orphan or specialty indications. Nontraditional sources of capital and innovative risk-sharing structures can enable early-stage companies.
In the past five years, the climate for commercial biotechnology in Germany has improved significantly and has resulted in an increase in the number of biotechnology companies. On examination of the underlying factors of the evolution of the biotechnology industry in Germany, and against the background of the current situation, it is predicted that many German biotech companies will have to change their business models to focus on product development rather than on platform technologies.
Empirical research shows that European governments and retailers are unlikely to be directly punished by taxpayers and consumers if they move away from their anti-GMO positions and policies. However, it is ultimately not the weak attitudes of taxpayers and consumers that matter to governments and retailers but the strong attitudes of the noisy anti-biotech movement. (Image: Highway signs: ©maxmitzu - Fotolia.com; woman and balance: ©lassedesignen - Fotolia.com).
I. Menéndez I
Full Text Available Transmission Electron Microscopy (TEM is a valuable tool for the biotech industry. This paper summarizes some of the contributions of MET in the characterization of the recombinant antigens are part of vaccines or vaccine candidates obtained in the CIGB. It mentions the use of complementary techniques MET (Negative staining, and immunoelectron that enhance visualization and ultrastructural characterization of the recombinant proteins obtained by Genetic Engineering.
Schneider, B.W. (Bernd)
Industrial biotechnology, also known as white biotechnology, is considered to be a revolutionary biotechnology field beside red and green biotechnology. After red (medicine) and green (agriculture), white biotechnology is now gaining momentum. With numerous applications e.g. in biocatalysis and fermentation technology, white biotech companies are able to produce – often from biomass out of agricultural products - biobased chemicals (like vitamins, amino acids or enzymes for textile finishing ...
Dornburg, V.; Hermann, B.G.; Patel, M.K.
Three scenario projections for future market potentials of biobased bulk chemicals produced by means of white biotechnology are developed for Europe (EU-25) until the year 2050, and potential nonrenewable energy savings, greenhouse gas emission reduction, and land use consequences are analyzed. These scenarios assume benign, moderate, and disadvantageous conditions for biobased chemicals. The scenario analysis yields a broad range of values for the possible market development of white biotech...
Knowledge about the crop biology of economic crops in Africa is needed for regulators to accurately review dossiers and conduct comprehensive environmental risk assessments (ERAs). This information allows regulators to decide whether biotech crops present a risk to biodiversity, since crossing between domesticated crops and their wild relatives could affect the adaptations of the wild species. The criteria that should be used in the evaluation of African crops for ERA include growth habit, ce...
Knowledge about the crop biology of economic crops in Africa is needed for regulators to accurately review dossiers and conduct comprehensive environmental risk assessments (ERA). This information allows regulators to decide whether biotech crops present a risk to biodiversity, since crossing between domesticated crops and their wild relatives could affect the adaptations of the wild species. The criteria that should be used in the evaluation of African crops for environmental risk assessmen...
SantaCruz Biotec), against ER protein. Methodology was established on individual sections cut from paraffin blocks, and was then applied to tissue arrays...cell transfections anti-GFP-peptide antibody ( SantaCruz Biotechnology, Santa for flow cytometry. This minimized the possibility that DNA Cruz, CA) and... SantaCruz BioTech- influence results. nology) was used as secondary antibody and detection was by chemi-luminescence using the Pierce ’super-signal’ sys- 2.2
Engell-Noerregaard, Lotte; Kvistborg, Pia; Zocca, Mai-Britt
Background: We evaluated the clinical and immunological effects of dendritic cell (DC) vaccination of patients with NSCLC. Autologous DCs were pulsed with a MAGE containing allogeneic melanoma cell lysate (MelCancerVac®, Dandrit Biotech, Copenhagen, Denmark). Imiquimod cream, proleukin......-layed effect of DC vaccination after completion of the treatment. A prospective randomized phase-IIb or -III is needed to further evaluate the use of MelCancerVac® vaccine treatment in patients with progressive NSCLC....
An introductory and short explanation is summarized here for following five papers from the U.S.A., Germany, India, China, and Japan. Main topics include the reason of attention to biopharmaceutical industry, the global trend of commercialization of life science, the characteristics of advanced countries as the U.S.A. and Europe and of emerging countries as India and China, and Japan's trend of number of biotech start-ups, business areas, and venture capital.
Kim, ChangKug; Park, DongSuk; Seol, YoungJoo; Hahn, JangHo
The National Agricultural Biotechnology Information Center (NABIC) constructed an agricultural biology-based infrastructure and developed a Web based relational database for agricultural plants with biotechnology information. The NABIC has concentrated on functional genomics of major agricultural plants, building an integrated biotechnology database for agro-biotech information that focuses on genomics of major agricultural resources. This genome database provides annotated genome information from 1,039,823 records mapped to rice, Arabidopsis, and Chinese cabbage. PMID:21887015
Woollett, G R
Innovation is assumed to be a good thing in health care, just as it is elsewhere, and to be crucial to the availability of greater choices for consumers. But what is it? Very little definition is provided when the term is used. This report discusses the following aspects of biotech innovation: innovation in medicinal products, innovation in manufacturing processes, and innovation in regulatory science (both oversight and licensure).
to meet future demands. However, improving crop production through the use of genetics offers a sustainable alternative. Companies such as Monsanto ...Nations Population Division, World Population Prospects, September 20, 2007, http://esa.un.org/unpp/. 25 Monsanto Company, “ Monsanto ~ Our Products...papers.cfm?abstract_id=1321054 28 Monsanto Company, "Conversations About Plant Biotechnology," April 25, 2009, http://www.monsanto.com/biotech-gmo/asp
2011, Cientifica also concluded that the United States had fallen behind both Russia and China in nanotechnology R&D funding on a purchasing power...especially in combination with information technology, biotechnology , and the cognitive sciences, may deliver revolutionary advances, including... Biotechnology , Vol. 1, No. 3, Fall 2005, http://www.nsf.gov/crssprgm/nano/ reports/mcr_ind_biotech_interview.pdf. 23 Fifteen agencies received funding in
Claudia Gragnoli1,21Center for Biotechnology and Department of Biology, College of Science and Technology, Temple University, Philadelphia, PA, USA; 2Molecular Biology Laboratory, Bios Biotech Multi-Diagnostic Health Center, Rome, ItalyAbstract: Depression, type 2 diabetes (T2D), and metabolic syndrome (MetS) are often comorbid. Depression per se increases the risk for T2D by 60%. This risk is not accounted for by the use of antidepressant therapy. Stress causes hyperactivation of the hypotha...
Raastrup Kristensen, Anders; Pedersen, Michael
as part of an individuation process, neither reducible to the sphere of work nor of life. Qualitative data gathered at a global biotech firm has demonstrated how problems related to work–life balance, such as working while ill and working from home, illustrate ways employees become individuated....... The article ends by discussing the contribution and relevance of Simondon’s thinking to current theories of work–life balance in relation to research methodology and ethics....
Full Text Available | antibody vendorid=sc-268 || treatment description=1 h with 0.02% Dimethyl sufloxide (DMSO) (Myers) || cont... Cruz Biotech || antibody vendorid=sc-268 || treatment=DMSO_0.02pct || treatment description=1 h with 0.02% DMSO (Myers...ation by probe-in sonicator, one 15-cycle round of PCR (Myers) || controlid=SL1881 || labexpid=SL2636 || rep
Full Text Available treatment description=1 h with 100 nM Dexamethasone (Myers) || protocol description=a 25-cycle round of PCR ...and an additional 15-cycle round of PCR after gel size selection (Myers) || contr...ta Cruz Biotech || antibody vendorid=sc-1004 || treatment=DEX_100nM || treatment description=1 h with 100 nM DEX (Myers...) || protocol=PCR2x || protocol description=2-cycles of PCR (Myers) || controlid=SL247 || labexpi
Mayorca-Guiliani A; Erler JT
Alejandro Mayorca-Guiliani, Janine T Erler Biotech Research and Innovation Centre, University of Copenhagen, Copenhagen, Denmark Abstract: The extracellular matrix (ECM) is the physical scaffold where cells are organized into tissues and organs. The ECM may be modified during cancer to allow and promote proliferation, invasion, and metastasis. The family of lysyl oxidase (LOX) enzymes cross-links collagens and elastin and, therefore, is a central player in ECM deposition and maturation. Exte...
Khramtsov, Andrey; Evdokimov, Ivan; Lodygin, Aleksey; Budkevich, Roman
The information available on high technology in food industry is systematized. Different approaches to the development and integration of scientific knowledge are discussed. According to the European Institute for Food Processing (EU-IFP), there are three possible areas where a breakthrough in food science can occur: biotechnology (BIOTECH), nanotechnology (NANO), and information and communication technology (ICT). A transition is expected of high technology in food industry to convergent tec...
In the modern healthcare and medical sectors corporate bio-pharmaceutical firms continue to scale down their\\ud in-house research and development (R&D) activities in favour of outsourcing the services to bio-tech ventures.\\ud These small but, entrepreneurial research-oriented organisations have increased dramatically. They are\\ud predominantly owned by bio-entrepreneurs who are extensively experienced scientists. In the science-based\\ud industry they operate in, innovation “ecosystems” consis...
Introduction: The Genetically Modified (GM) food, which is one of the fruit of the modern biotechnology, is closely related to people's lives. GM food, specifically, GM crops, also known as biotech food, are produced from genetically modified organisms (GMO), which use genetic engineering techniques to introduce, recombine and modify DNA. The safety of GM food still do not have final conclusion at present. Although GM food has been introduced into China for over 15 years, many of the surveys ...
LI HongCheng; ZHOU QunFang; LIU Wei; YAN Bing; ZHAO Yibing; JIANG GuiBin
Quantum dots (QDs) have Received more and more attention as a novel example of nanomaterials. Due to their unique fluorescent characteristics, quantum dots have been successfully applied in biotech-nology and medicine applications. Recently, the toxicity and the potential environmental effects of QDs have become a research hotspot. In this paper, toxicological effects of QDs are reviewed, and the prospects and research directions are given based on the analysis of this research field.
Harris, Rebecca C
This article reviews biotechnology legislation in the 50 states for 11 policy areas spanning 1990-2010, an era of immense growth in biotechnology, genetic knowledge, and significant policy development. Policies regarding health insurance, life insurance, long-term care insurance, DNA data bank collection, biotech research protection, biotech promotion and support, employment discrimination, genetic counselor licensing, human cloning, and genetic privacy each represent major policy responses arising from biotechnology and coinciding with key areas of state regulation (insurance, criminal justice, economic development, labor law, health and safety, privacy, and property rights). This analysis seeks to answer three questions regarding biotechnology legislation at the state level: who is acting (policy adoption), when is policy adopted (policy timing), and what is policy doing (policy content). Theoretical concerns examine state ideology (conservative or liberal), policy type (economic or moral), and the role of external events (federal law, news events, etc.) on state policy adoption. Findings suggest ideological patterns in adoption, timing, and content of biotech policy. Findings also suggest economic policies tend to be more uniform in content than moral policies, and findings also document a clear link between federal policy development, external events, and state policy response.
Full Text Available The SudBiotech project is targeting PhD and Masters Programmes in Universities and Excellence Research Centres located in developing countries. It proposes an integrative and multidisciplinary approach under the form of a one-week discovery and training itinerary. SudBiotech is aimed at addressing various different fields of Plant Biotechnology, under the specific socioeconomic context of scientific communities from these countries. Our main goal is to train students, research staff, deciders, professionals and journalists to the basic knowledge underlying applications of plant biotechnologies, in order to both update the amount of knowledge which is requested at Master’s level and to acquire a solid body of information which is indispensable for any decision making, in a field of research which is often the target of political, social and media-related pressure. The team of Professors involved in the project shares a strong experience in teaching and training in overseas French Speaking Universities (AUPELF-UREF projects in Marocco, Tunisia, Togo, Côte d’Ivoire, TEMPUS Programme in Lebanon, AUF-Actions de Recherche en Réseau in Benin. The team is composed of senior scientists acting in various complementary fields, namely: Biochemistry/Physiology (A. Nato, Plant Breeding/Molecular Biology (Y. Henry, Tropical Agriculture/Epigenetics (A. Rival. Thanks to these complementarities, SudBiotech is able to propose a training itinerary which is diversified and integrated, covering areas from the plant cell and its original potentialities to the most recent industrial applications of plant biotechnologies (GMOs, their public acceptance in developing and emerging nations and their applicability to tropical plant commodities. The training offer is amplified and enriched through the active role of local research and training staff, who are encouraged to actively participate in the SudBiotech project under various forms including lectures, field visits
Philipp J.P. Garbade
Full Text Available The present paper aims at answering the question how cluster organization functions are implemented in a high‐tech, a medium to high‐tech and a low to medium‐tech cluster. Data were collected by semi‐structured interviews from three clusters in the Netherlands, an agri‐food cluster (as an example of a low to medium‐tech cluster, a green biotech cluster (medium to high‐tech and a high‐tech cluster. Concerning the cluster organization functions a number of similarities were found. For all three clusters it can be concluded that the network support function is considered to be very important. Sector independence can further be found concerning the innovation process support function, specifically regarding the promotion of the region as an attractive living and working area for highly qualified employees. The results also show anumber of clear differences among the investigated clusters. Only in the low‐to‐medium tech agri‐food cluster there was a clear need for internationalization support for SMEs to reach foreign markets. Only in the green biotech cluster the demand articulation was focused on the region where the cluster is based, which stands in contrast to the highly international orientation of the member companies. Only in the high‐tech innovation cluster technology road mapping was extensively used. This powerful tool, developed to align the innovation process at the company and sector level, impacted further on the execution of the demand articulation/ network formation support functions, and could also be helpful for the green biotech and the agri‐food clusters. Throughout the paper different cluster categorization schemes are besides the tech level are applied and give insights on their limitations and how to possibly deal with them in inter sectorial cluster comparison research.
Pallati, P K; Puri, V; Mittal, S K
An 89-year old female presented to us with symptoms of gastric outlet obstruction which appeared to be secondary to gastric volvulus on preoperative work-up. On laparoscopy the stomach was found to be incarcerated in a right-sided Morgagni hernia with surrounding adhesions. The hernia was reduced after dissecting the adhesions and the diaphragmatic defect was repaired using a biologic mesh onlay patch (Surgisis GOLD, Cook Biotech Inc.). Her postoperative recovery was uneventful and she was doing well at three months follow-up.
Bonde, Mads; Makransky, G.; Wandall, J.
constrained by safety concerns. Combining gamification elements with simulations may provide an opportunity for great gains in learning effectiveness and motivation of biotech students. An advanced laboratory simulation platform based on mathematical algorithms supporting open-ended investigations...... was developed and combined with gamification elements such as an immersive 3D universe, storytelling, conversations with fictional characters and a scoring system. Two gamified laboratory simulations were tested: a crime-scene lab and a genetic engineering lab (http://www.labster.com/biolabs/). A study testing...
Uldbjerg, Niels; Singh, Ripudaman; Christensen, Rikke;
CONTROL ID: 2520273 ABSTRACT FINAL ID: OC06.03 TITLE: Cell based Non-invasive Prenatal Testing (NIPT) AUTHORS (FIRST NAME, LAST NAME): Niels Uldbjerg2, Ripudaman Singh4, Rikke Christensen3, Palle Schelde4, Ida Vogel1, Else Marie Vestergaard3, Lotte Hatt4, Steen Kølvrå4 INSTITUTIONS (ALL): 1....... Department of Clinical Genetics, Aarhus University Hospital, Aarhus N, none, Denmark. 2. Obstetrics and Gynecology, Aarhus University Hospital Skejby, Aarhus, Denmark. 3. Clinical Genetics, Aarhus University Hospital, Aarhus, Denmark. 4. Arcedi Biotech Aps, Aarhus, Denmark. ABSTRACT BODY: Objectives: NIPT...
Full Text Available In this case we present a business decision-making situation in which the CEO of an Argentine Ag Biotech company, Bioceres, has to decide the best way to commercialize a new drought-tolerant transgenic technology. The company was founded by twenty three farmers, who shared a common dream that Argentina could become a benchmark in the development of Ag biotechnology. The case has strategic and financial implications, as well as decision-making situation involving a joint venture with an American biotechnology company. It also introduces to discussion the business models of Ag biotechnology companies in developing countries.
In vitro diagnostics (IVD) has huge potential. Primary drivers in the global market are the patient's awareness of infectious diseases, the introduction of advanced molecular and tissue diagnostic tests for patient-stratified and targeted anti-cancer therapy and, last but not least, the growing geriatric population. Rapid progress in device miniaturization and information technology (IT) offers new possibilities in decentralized testing. Grand View Research Inc. expects the global market for IVD to reach US $ 74.3 billion by 2020. Hence the launch in 2015 by the NTN Swiss Biotech - together with the driving forces of Biotechnet Switzerland - of the 'Thematic Platform in vitro Diagnostics'.
The 10th Workshop on Recent Issues in Bioanalysis (WRIB) held in Orlando, USA, in April 2016. It drew close to 500 professionals representing large pharmas, biotechs, CROs and multiple regulatory agencies from around the world, working on both small- and large-molecule bioanalysis. This year, bioanalysis and bioanalysis zone were proud to support the WRIB Poster Awards and we feature profiles of the authors of the winning posters. Go to www.bioanalysis-zone.com to see the winning posters in full. Winning posters.
Uckun, F M; Frankel, A
The Third International Symposium on Immunotoxins was held on June 19-21, 1992 in Orlando, Florida. This symposium was sponsored by NATO, NIH, Pierce Chemical Company, Walt Disney Cancer Institute at Florida Hospital, Duke Comprehensive Cancer Center, Xoma, Immunogen, Seragen, Bristol-Myers Squibb, Chiron, Ortho Biotech, Upjohn, Merck Sharp & Dohme Research Laboratories, Abbot Laboratories, Lilly Research Laboratories, and Evans & Sutherland. The Pierce Immunotoxin Award which recognizes outstanding contributions to immunotoxin research and development, was presented to Drs David FitzGerald, Fatih Uckun, David Eisenberg, and Ira Wool, for their contributions to the immunotoxin field.
Qiu, Yuan‐Zheng; Yin, Wei‐Dong
Abstract Sinovac Biotech started to develop prototype pandemic influenza H5N1 vaccines in March 2004. On 2 April 2008, Sinovac’s inactivated, aluminium‐adjuvanted, whole‐virion prototype pandemic influenza A (H5N1) vaccine (PanFlu™) was granted production licensure by the China regulatory authority State Food and Drug Administration. The whole‐virion H5N1 vaccine was manufactured in embryonated hens’ eggs using the reassortant strain NIBRG‐14 (A/Vietnam/1194/2004‐A/PR/8/34) as vaccine virus....
Tosello, Guido; Calaon, Matteo; Nørregaard, J.
The strategic research centre PolyNano aims at becoming the Danish competence centre for production-ready fabrication of polymer, nano-scale lab-on-a-chip (LoC) devices. In order to provide a competitive edge for Danish biotech companies launching LoC products by removal of the technology barrier...... between lab-scale proof-of-principle and high-volume low-cost production of LoCs, the PolyNano project will develop a readily accessible fabrication platform for those companies aiming at developing and manufacturing their LoCs design....
Chinese labs begin R&D for Big Pharma and other biotech companies It came down to three countries for Bridge Pharmaceuticals' new animal testing lab: India, Singapore and China. In the process India fell out of the equation. "India doesn't have primates or dogs," said Glenn Rice, the Menlo Park, California-based company's president and CEO. India is a great place for small molecule manufacturing but not for toxicology testing on animals because the right breeders are not available there, Rice
Steve Reed believes the organization he has founded has the potential to radically increase the developing world's access to vaccines for neglected diseases. The efforts of the Seattle-based Infectious Disease Research Institute (IDRI), which operates as a not-for-profit biotech company, may start to pay off during the H1N1 'swine' flu pandemic. IDRI developed an adjuvant to boost the effectiveness and supplies of flu vaccines and is making the technology available to vaccine manufacturers in developing nations. Charlotte Schubert talks to Reed about how IDRI, a 90-person operation with a $19 million annual budget, could have such a big impact.
Knowles, Richard Graham
The research and development process for novel drugs to treat inflammatory diseases is described, and several current issues and debates relevant to this are raised: the decline in productivity, attrition, challenges and trends in developing anti-inflammatory drugs, the poor clinical predictivity of experimental models of inflammatory diseases, heterogeneity within inflammatory diseases, 'improving on the Beatles' in treating inflammation, and the relationships between big pharma and biotechs. The pharmaceutical research and development community is responding to these challenges in multiple ways which it is hoped will lead to the discovery and development of a new generation of anti-inflammatory medicines.
Full Text Available This article reviews major micro- and nanolithography techniques and their applications from commercial micro devices to emerging applications in nanoscale science and engineering. Micro- and nanolithography has been the key technology in manufacturing of integrated circuits and microchips in the semiconductor industry. Such a technology is also sparking a magnificent transformation of nanotechnology. The lithography techniques including photolithography, electron beam lithography, focused ion beam lithography, soft lithography, nanoimprint lithography and scanning probe lithography are discussed. Furthermore, their applications are reviewed and summarized into four major areas: electronics and microsystems, medical and biotech, optics and photonics, and environment and energy harvesting.
Wang, Liangsu; Plump, Andrew; Ringel, Michael
The pharmaceutical industry continues to face fundamental challenges because of issues with research and development (R&D) productivity and rising customer expectations. To lower R&D costs, move beyond me-too therapies, and create more transformative portfolios, pharmaceutical companies are actively capitalizing on external innovation through precompetitive collaboration with academia, cultivation of biotech start-ups, and proactive licensing and acquisitions. Here, we review the varying innovation strategies used by pharmaceutical companies, compare and contrast these models, and identify the trends in external innovation. We also discuss factors that influence these external innovation models and propose a preliminary set of metrics that could be used as leading indicators of success.
supported in part by this award: Ph.D. SUNY Stony Brook: Zhou Zhou Ph.D. SUNY Stony Brook: Peng Wang Ph.D. SUNY Stony Brook: Qiu- zhe Xie Ph.D. SUNY...Stolarzewicz Ph.D. SUNY Stony Brook: Pei Wang Continuing in the PhD program at SUNY Stony Brook Junyong Lee Hee Nam Lim Daniel C. Elliot Matthew E...IBS) in Waltham, MA. Intelligent Biosystems is a biotech company that is focused on efficient gene sequencing. Peng Wang is employed by Ren
Jørgensen, Heidi; Vintergaard, Christian
isprovided, that the relation between a company's strategy, structure and processesin fact have a considerable influence on its pattern of network behaviour. Threecase studies from the Danish biotech industry exemplify and illustrate how acompany's strategy is directly correlated with how it manages its...... of networkbehaviour, knowing how to manage this relation becomes essential, especiallyduring the development of new strategies.......Logically it seems that companies pursuing different business strategies wouldalso manage their relationships with other firms accordingly. Nevertheless, due tothe lack of research in the field of network strategies, this link still remainsinadequately examined. Based on the well-known framework...
Lévová, Tereza; Hauschild, Michael Zwicky
use also depends on the local sensitivity to freshwater extraction, and the change in the quality from water intake to discharge of the usedwater. A methodology is presented catering to these characteristics of the water use issue and demonstrated on an industrial case study from the biotech industry.......Use of freshwater gives rise to important environmental impacts to consider in the sustainability analysis of an industry or a product. Water use impacts are highly dependent on the local or regional conditions, and apart from the quantity that is extracted and used, the impact of the freshwater...
Innovation in medicine requires unique partnerships between academic research, biotech or pharmaceutical companies, and health-care providers. While innovation in medicine has greatly increased over the past 100 years, innovation in wound care has been slow, despite the fact that chronic wounds are a global health challenge where there is a need for technical, process and social innovation. While novel partnerships between research and the health-care system have been created, we still have much to learn about wound care and the wound-healing processes.
Andersen, Bente Hessellund; Jørgensen, Michael Søgaard
and a measure to reduce climate impact and nuisances from slurry, while NGOs fear slurry-based biogas is used as argument for increased animal husbandry. A biotech company develops enzymes for processing of biomass for second generation biofuels, which has obtained some support, while others see this as merely...... and the environmental impacts of using bioenergy: Energy companies convert coal fired power plants into imported biomass to sustain the role of these power plants in the transition towards renewable energy, while some NGOs claim that this practice will not reduce emissions. Farmers see slurry as a source for biogas...
Andrei Ştefan Săbău
Full Text Available How can one describe the components of an innovative region? What characterizes a region as being innovative? This paper presents the close relationship between innovation and regional development in an empirical analysis of the Öresund Region (the south-western part of Scandinavia: Sweden and Denmark, arguing the role of the universities, public institutions and R&D companies in placing the Öresund Region on the map as a world-leading player in providing biotech and medical technology.
Biotech may have less to fear from Rifkin than from its own inclination to dismiss the fact that the evolution of ethics and patent laws applying to patenting genes has been haphazard. Perhaps it is time for the biotechnology industry to get behind the establishment of an effective forum for opening much-needed dialogue. Perhaps a Senate proposal to establish a bioethics commission, which reportedly has bogged down in partisan politics, is just such a venue for the government and private sector to begin to hash out the ethical and legal dilemmas that are indisputably at the heart of the biotechnology industry, and its future success.
Chantelot, Emmanuel; Suojanen, Christian
This article reviews the current economic crisis as it impacts upon European biopharma SMEs and their ability to secure investment and funding. In particular it presents an analysis of a broader, pre-crisis structural problem in Europe related to the lack of institutional investors for Europe's life sciences venture capital funds and the impact this has both on the funds available for investment by VCs into Europe's biotech companies, and the effect on the type and stage of biopharma companies able to raise money. This article also presents an overview of an on-going stakeholder dialogue to address these issues and the proposals raised so far for possible solutions.
Full Text Available The world of renewable energies is in fast evolution and arouses political and public interests, especially as an opportunity to boost environmental sustainability by mitigation of greenhouse gas emissions. This work aims at examining the possibilities related to the development of biorefineries, where biomass conversion processes to produce biofuels, electricity and biochemicals are integrated. Particular interest is given to the production processes of biodiesel, bioethanol and biogas, for which present world situation, problems, and perspectives are drawn. Potential areas for agronomic and biotech researches are also discussed. Producing biomass for biorefinery processing will eventually lead to maximize yields, in the non food agriculture.
In considering new directions for low gravity research with particular regard to broadening the number and types of industrial involvements, it is noted that transport phenomena play a vital role in diverse processes in the chemical, pharmaceutical, food, and biotech industries. Relatively little attention has been given to the role of gravity in such processes. Accordingly, numerous industrial processes and phenomena are identified which involve gravity and/or surface tension forces. Phase separations and mixing are examples that will be significantly different in low gravity conditions. A basis is presented for expanding the scope of the low gravity research program and the potential benefits of such research is indicated.
Full Text Available anta Cruz Biotechnology || antibody vendorid=sc-5916 || treatment description=1 h with 100 nM Dexamethasone (Myers...) || protocol description=one 15-cycle round of PCR (Myers) || controlid=SL474 || labexpid=SL1204,SL10...anta Cruz Biotech || antibody vendorid=sc-5916 || treatment=DEX_100nM || treatment description=1 h with 100 nM DEX (Myers...) || protocol=PCR1x || protocol description=1-cycle of PCR (Myers) || controlid=SL474 || labexp
Full Text Available e=Santa Cruz Biotechnology || antibody vendorid=sc-5916 || treatment description=1 h with 0.02% Ethanol (Myers...) || protocol description=one 15-cycle round of PCR (Myers) || controlid=SL475 || labexpid=SL1205,SL1078 |... Cruz Biotech || antibody vendorid=sc-5916 || treatment=EtOH_0.02pct || treatment description=1 h with 0.02% EtOH (Myers...) || protocol=PCR1x || protocol description=1-cycle of PCR (Myers) || controlid=SL475 || labexpi
Sanseau, Philippe; Chabot-Fletcher, Marie; Browne, Michael J
The 1990s and early years of this century have seen a series of large-scale mergers and acquisitions in the Pharmaceutical and Biotech arena. These activities each required integration at multiple levels. One of the most important activities is the integration of the R&D pipelines of the participants. We outline the combined portfolio and bioinformatic strategy that was used, and detail the lessons learned for the longer term, from the GlaxoWellcome-SmithKline-Beecham merger in 2000. To date, this has been the largest merger of two equally sized Pharma R&D organisations.
With the recent outbreak of large mergers and acquisitions and the looming pipeline crisis among large pharmaceutical companies, this meeting aimed to bring together senior officers from the business development and licensing sectors of top biotech and pharma companies, to discuss all aspects of licensing with a focus on remaining competitive. Along with in-depth analyses and theories delivered by representatives from investment banks, consultancy firms and academia, the conference presented delegates with interesting viewpoints and practical advice on partnering strategies, and issues surrounding licensing.
Daly, M J; Guignard, B; Nendaz, M
Drugs are the third largest source of expenditure under Switzerland's compulsory basic health insurance. Generics, the price of which should be at least 30 per cent less than the cost of the original drugs, can potentially allow substantial savings. Their approval requires bioequivalence studies and their use is safe, although some factors may influence patients' and physicians' acceptance. The increased substitution of biosimilar drugs for more expensive biotech drugs should allow further cost savings. In an attempt to extend the monopoly granted by the original drug patent, some pharmaceutical companies implement "evergreening" strategies including small modifications of the original substance for which the clinical benefit is not always demonstrated.
Prajapati P M.
Full Text Available A nanorobot is a tiny machine designed to perform a specific tasks repeatedly and with precision at nanoscale dimensions. Nanorobotics will have a diameter of about 0.5 to 3 microns and will be constructed out of parts with dimensions in the range of 1 to 100 nanometres. Nanorobotics has strong potential to revolutionize healthcare, to treat disease in future. It opens up new ways for vast, abundant research work. Nanotechnology will change health care and human life more profoundly than other developments. Consequently they will change the shape of the industry, broadening the product development and marketing interactions between Pharma, Biotech, Diagnostic and Healthcare industries.
Patrick Quercia,1,2 Madeleine Quercia,3 Léonard J Feiss,3 François Allaert4 1Department of Ophthalmology, University Hospital, 2INSERM U1093, University Bourgogne Franche-Comté, Dijon, 3Office of Ophthalmology, Beaune, 4CEN Biotech, Dijon, France Abstract: In this study, we looked for the presence of vertical heterophoria (VH) in 42 dyslexic children (22 males and 20 females) aged 118.5±12.9 months who were compared with a control group o...
Full Text Available The 2010 Beltwide Cotton Conferences provided a new vision of the consequences of about 15 years of widespread and uncoordinated cropping of transgenic cotton in the United States. Insect-resistant and/or herbicide-tolerant cotton varieties modified parasite complexes, namely those of insects and weeds damaging cotton crops. The Conferences have revealed that the adaptation solutions so far proposed make illusory the expectations at the launch of transgenic cotton, in terms of effective pest control, cost reduction, and antagonism between chemical and biotech methods. The USA case points out that the technical and economic sustainability of transgenic varieties must lie in a systemic and coordinated approach.
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Full Text Available nosis=Fibrocystic Disease 61955386,94.5,36.1,18987 GSM935400: Harvard ChipSeq MCF10A-Er-Src 4OHTAM 1uM 36hr E2F4 Harvard... Control source_name=MCF10A-Er-Src || biomaterial_provider=Struhl laboratory || lab=Harvard || l...antibody vendorname=Santa Cruz Biotech || antibody vendorid=sc-866 || control=Harvard_Control || control des...cription=input library was prepared at Harvard. || control=Harvard_Control || control description=input library was prepared at Harva...ab description=Struhl - Harvard University || datatype=ChipSeq || datatype descri
Full Text Available gnosis=Fibrocystic Disease 36921541,91.0,24.5,48136 GSM935399: Harvard ChipSeq MCF10A-Er-Src 4OHTAM 1uM 12hr STAT3 Harvard... Control source_name=MCF10A-Er-Src || biomaterial_provider=Struhl laboratory || lab=Harvard ||... lab description=Struhl - Harvard University || datatype=ChipSeq || datatype desc...esses such as cell growth and apoptosis. || antibody vendorname=Santa Cruz Biotech || antibody vendorid=sc-482 || control=Harvard..._Control || control description=input library was prepared at Harvard. || control=Harvard
Full Text Available osis=Fibrocystic Disease 50667127,93.3,23.9,80828 GSM935438: Harvard ChipSeq MCF10A-Er-Src EtOH 0.01pct c-Fos Harvard... Control source_name=MCF10A-Er-Src || biomaterial_provider=Struhl laboratory || lab=Harvard || lab description=Struhl - Harv...me=Santa Cruz Biotech || antibody vendorid=sc-7202 || control=Harvard_Control || control description=input l...ibrary was prepared at Harvard. || control=Harvard_Control || control description...=input library was prepared at Harvard. || controlid=wgEncodeEH002871 || replicate=1 http://dbarchive.biosci
Full Text Available osis=Fibrocystic Disease 66690540,98.1,24.9,110111 GSM935398: Harvard ChipSeq MCF10A-Er-Src 4OHTAM 1uM 12hr c-Fos Harvard... Control source_name=MCF10A-Er-Src || biomaterial_provider=Struhl laboratory || lab=Harvard || ...lab description=Struhl - Harvard University || datatype=ChipSeq || datatype descr... is a leucine-zipper. || antibody vendorname=Santa Cruz Biotech || antibody vendorid=sc-7202 || control=Harvard..._Control || control description=input library was prepared at Harvard. || control=Harvard
Full Text Available osis=Fibrocystic Disease 60050220,94.5,18.5,85444 GSM935396: Harvard ChipSeq MCF10A-Er-Src 4OHTAM 1uM 36hr c-Fos Harvard... Control source_name=MCF10A-Er-Src || biomaterial_provider=Struhl laboratory || lab=Harvard || l...is a leucine-zipper. || antibody vendorname=Santa Cruz Biotech || antibody vendorid=sc-7202 || control=Harvard..._Control || control description=input library was prepared at Harvard. || control=Harvard..._Control || control description=input library was prepared at Harvard. || controlid=wgEncodeEH0028
Full Text Available osis=Fibrocystic Disease 64692659,93.8,19.3,37417 GSM935491: Harvard ChipSeq MCF10A-Er-Src 4OHTAM 1uM 4hr c-Myc Harvard... Control source_name=MCF10A-Er-Src || biomaterial_provider=Struhl laboratory || lab=Harvard || la...ntibody vendorname=Santa Cruz Biotech || antibody vendorid=sc-764 || control=Harvard_Control || control desc...ription=input library was prepared at Harvard. || control=Harvard_Control || cont...rol description=input library was prepared at Harvard. || controlid=wgEncodeEH002871 || replicate=1 http://d
Full Text Available A 16-year-old girl presented with left fourth metatarsal shortening causing significant psychological distress. She underwent lengthening scarf osteotomy held with an Omnitech® screw (Biotech International, France with the addition of two 1 cm cancellous cubes (RTI Biologics, United States. A lengthening z-plasty of the extensor tendons and skin were also performed. At 6 weeks the patient was fully weight bearing and at one-year follow up, the patient was satisfied and discharged. A modified technique of lengthening scarf osteotomy is described for congenital brachymatatarsia. This technique allows one stage lengthening through a single incision with graft incorporation by 6 weeks.
印度的Bharat Biotech International公司将被获准使用Novavax公司的病毒样质粒（VLP）疫苗技术为印度和其他南亚市场研发流行性感冒疫苗。Bharat将为所有临床前和临床研究提供资金，帮助开发生产程序并负责所有的商业活动。
In modern biotech production, a massive number of diverse measurements, with a broad diversity in information content and quality, is stored in data historians. The potential of this enormous amount of data is currently under-employed in process optimization efforts. This is a result of the deman......In modern biotech production, a massive number of diverse measurements, with a broad diversity in information content and quality, is stored in data historians. The potential of this enormous amount of data is currently under-employed in process optimization efforts. This is a result...... and difficulties related to ‘recycling’ of historical data from a full-scale manufacturing of industrial enzymes. First, the crucial and tedious step of retrieving the data from the systems is presented. The prerequisites that need to be comprehended are discussed, such as sensors accuracy and reliability, aspects...... related to the actual measuring frequency and non-equidistance retaining strategies in data storage. Different regimes of data extraction can be employed, and some might introduce undesirable artifacts in the final analysis results (POSTER II1). Several signal processing techniques are also briefly...
Full Text Available Maize is an important food and feed crop in many countries. It is also one of the most important target crops for the application of biotechnology. Currently, there are more biotech traits available on the market in maize than in any other crop. Generation of transgenic events is a crucial step in the development of biotech traits. For commercial applications, a high throughput transformation system producing a large number of high quality events in an elite genetic background is highly desirable. There has been tremendous progress in Agrobacterium-mediated maize transformation since the publication of the Ishida et al. (1996 paper and the technology has been widely adopted for transgenic event production by many labs around the world. We will review general efforts in establishing efficient maize transformation technologies useful for transgenic event production in trait research and development. The review will also discuss transformation systems used for generating commercial maize trait events currently on the market. As the number of traits is increasing steadily and two or more modes of action are used to control key pests, new tools are needed to efficiently transform vectors containing multiple trait genes. We will review general guidelines for assembling binary vectors for commercial transformation. Approaches to increase transformation efficiency and gene expression of large gene stack vectors will be discussed. Finally, recent studies of targeted genome modification and transgene insertion using different site-directed nuclease technologies will be reviewed.
Fernanda Daniela Serralvo
Full Text Available Introduction: The efficacy and safety in treatment with oral anticoagulants are dependent on the monitoring of the effect of anticoagulants by the prothrombin time (PT. The system INR (International Normalized Ratio was developed to minimize the variability in the PT, mainly because of the thromboplastin reagent used. Objective: Compare the results of INR employing six thromboplastins and plasmas of patients using oral anticoagulants. Materials and Methods: For this study, 96 patients using oral anticoagulants and that had TP collected for monitoring anticoagulants were selected randomly. INR values were determined using six commercially available thromboplastin brands. Results and Discussion: Of the 96 patients, 29 were with the INR between 2 and 3 when used reagents Dade-Behring®, Human do Brasil® and Diagnostica Stago®. Regardless of the range of INR, the results obtained with the reagent Labtest® were statistically different from the Dade-Behring®, from Diagnostica Stago®, Trinity Biotech and Bios Diagnostica®. With INR between 2 and 3 only differences were observed between the results of brands and Bios Diagnostica® Labtest®. With INR above 3, the results of Labtest® were different from the Dade-Behring®, from Diagnostica Stago®, Trinity Biotech® and Bios Diagnostica®. Conclusion: Despite the establishment of INR, there are still significant differences in INR results depending on the thromboplastin brand used, which can interfere with the therapeutic approach in relation to oral anticoagulants.
Evens, Ronald; Kaitin, Kenneth
For more than three decades the field of biotechnology has had an extraordinary impact on science, health care, law, the regulatory environment, and business. During this time more than 260 novel biotechnology products were approved for over 230 indications. Global sales of these products exceeded $175 billion in 2013 and have helped sustain a vibrant life sciences sector that includes more than 4,600 biotech companies worldwide. In this article we examine the evolution of biotechnology during the past three decades and the profound impact that it has had on health care through four interrelated and interdependent tracks: innovations in science, government activity, business development, and patient care. The future impact of biotechnology is promising, as long as the public and private sectors continue to foster policies and provide funds that lead to scientific breakthroughs; governments continue to offer incentives for private-sector biotech innovation; industry develops business models for cost-effective research and development; and all stakeholders establish policies to ensure that the therapeutic advances that mitigate or cure medical conditions that currently have inadequate or no available therapies are accessible to the public at a reasonable cost.
Chen, Haidan; Gottweis, Herbert
The paper looks in detail at patients that were treated at one of the most discussed companies operating in the field of untried stem cell treatments, Beike Biotech of Shenzhen, China. Our data show that patients who had been treated at Beike Biotech view themselves as proactively pursuing treatment choices that are not available in their home countries. These patients typically come from a broad variety of countries: China, the United Kingdom, the United States, South Africa and Australia. Among the patients we interviewed there seemed to be both an awareness of the general risks involved in such experimental treatments and a readiness to accept those risks weighed against the possible benefits. We interpret this evidence as possibly reflecting the emergence of risk-taking patients as 'consumers' of medical options as well as the drive of patients to seek treatment options in the global arena, rather than being hindered by the ethical and regulatory constraints of their home countries. Further, we found that these patients tend to operate in more or less stable networks and groups in which they interact and cooperate closely and develop opinions and assessments of available treatment options for their ailments. These patients also perform a multiple role as patients, research subjects, and research funders because they are required to pay their way into treatment and research activities. This new social dynamics of patienthood has important implications for the ethical governance of stem cell treatments.
Wofford, Jay; Menter, Alan
Ustekinumab is a fully human monoclonal antibody directed against the p40 subunit shared by interleukin 12 and interleukin 23, two naturally occurring protein regulators that play an important role in immune-mediated inflammatory diseases, including psoriatic arthritis (PsA). In September of 2009, the US FDA approved ustekinumab for the treatment of adult patients with moderate to severe plaque psoriasis. Beginning in November of 2009, Janssen Biotech (formerly Centocor Biotech), the developer of ustekinumab, initiated clinical trials to investigate the efficacy of ustekinumab in the treatment of other inflammatory disorders, including PsA. Phase II and Phase III studies showed both a good safety profile and significant efficacy for ustekinumab in the treatment of PsA, leading to the drug's approval in both Europe and the USA. In an immunotherapy market currently dominated by anti-TNF-α drugs for the treatment of PsA, ustekinumab offers an alternative option for patients with PsA, including those unresponsive to methotrexate and the TNF-α inhibitory agents currently approved for this potentially debilitating disease.
Khush Gurdev S
Full Text Available Abstract The major scientific advances of the last century featured the identification of the structure of DNA, the development of molecular biology and the technology to exploit these advances. These breakthroughs gave us new tools for crop improvement, including molecular marker-aided selection (MAS and genetic modification (GM. MAS improves the efficiency of breeding programs, and GM allows us to accomplish breeding objectives not possible through conventional breeding approaches. MAS is not controversial and is now routinely used in crop improvement programs. However, the international debate about the application of genetic manipulation to crop improvement has slowed the adoption of GM crops in developing as well as in European countries. Since GM crops were first introduced to global agriculture in 1996, Clive James has published annual reports on the global status of commercialized GM crops as well as special reports on individual GM crops for The International Service for the Acquisition of Agri-biotech Applications (ISAAA. His 34th report, Global Status of Commercialized Biotech/ GM crops: 2011  is essential reading for those who are concerned about world food security.
Philipp J.P. Garbade
Full Text Available Policy makers are becoming increasingly aware of the fact that R&D intensive SMEs play a pivotal role in providing sustainable economic growth by maintaining a high rate of innovation. To compensate for their financial vulnerability, these SMEs increasingly conduct innovation in alliances. This paper aims to explore the impact of different alliance characteristics on the performance of Dutch biotechnology SMEs. The conceptual model was tested using a sample of 18 biotech SMEs reporting about 40 alliances. The main findings indicate that alliance performance is positively related to the level of complementarity, the cognitive distance and tacit knowledge transfer by the human resources exchanges. Policy makers are recommended to support innovation alliances by providing the infrastructure in which alliances can flourish, e.g. through stimulating the foundation of cluster organizations that can function as innovation brokers. These cluster organizations can provide network formation, demand articulation, internationalization and innovation process support to their member companies and can act as a go-between among alliance partners. As part of the innovation process support activities, they can organize special workshops for biotech SMEs on how to successfully behave in an innovation alliance.
Viejo, Marcos; Santamaría, María E; Rodríguez, José L; Valledor, Luis; Meijón, Mónica; Pérez, Marta; Pascual, Jesús; Hasbún, Rodrigo; Fernández Fraga, Mario; Berdasco, María; Toorop, Peter E; Cañal, María J; Rodríguez Fernández, Roberto
During development of multicellular organisms, cells become differentiated by modulating different programs of gene expression. Cells have their own epigenetic signature which reflects genotype, developmental history, and environmental influences, and it is ultimately reflected in the phenotype of the cells and the organism. However, in normal development or disease situations, such as adaptation to climate change or during in vitro culture, some cells undergo major epigenetic reprogramming involving the removal of epigenetic marks in the nuclei followed by the establishment of a different new set of marks. Compared with animal cells, biotech-mediated achievements are reduced in plants despite the presence of cell polypotency. In forestry, any sustainable developments using biotech tools remain restricted to the lab, without progressing to the field for application. Such barriers in the translation between development and implementation need to be addressed by organizations that have the power to integrate these two fields. However, a lack of understanding of gene regulation is also to blame for this barrier. In recent years, great progress has been made in unraveling the control of gene expression. These advances are discussed in this chapter, including the possibility of applying this knowledge in forestry practice.
Anthony, Vivienne M; Ferroni, Marco
Agricultural biotechnology holds much potential to contribute towards crop productivity gains and crop improvement for smallholder farmers in developing countries. Over 14 million smallholder farmers are already benefiting from biotech crops such as cotton and maize in China, India and other Asian, African and Central/South American countries. Molecular breeding can accelerate crop improvement timescales and enable greater use of diversity of gene sources. Little impact has been realized to date with fruits and vegetables because of development timescales for molecular breeding and development and regulatory costs and political considerations facing biotech crops in many countries. Constraints to the development and adoption of technology-based solutions to reduce yield gaps need to be overcome. Full integration with broader commercial considerations such as farmer access to seed distribution systems that facilitate dissemination of improved varieties and functioning markets for produce are critical for the benefits of agricultural biotechnology to be fully realized by smallholders. Public-private partnerships offer opportunities to catalyze new approaches and investment while accelerating integrated research and development and commercial supply chain-based solutions.
Based on the data released by the International Service for the Acquisition of Agri-biotech Applications(ISAAA), the paper ifrst gives a statistical analysis on the global genetically modiifed (GM) crops planted in 1996-2014 in terms of planted acres, countries, varieties, characteristics and economic beneifts , then summarizes the development status of global genetically modiifed crops, and ifnally gives some suggestions on the development of corresponding GM crops in China.%本文以国际农业生物技术应用服务组织（International Service for the Acquisition of Agri-biotech Applications，ISAAA）公布的相关数据为基础，对1996－2014年全球转基因农作物种植的面积、国家、品种、特性以及经济效益等进行统计分析，总结全球转基因作物种植的发展态势，并提出中国发展转基因作物的建议。
Bade, Pratap D; Kotu, Susmitha P; Rathore, Anurag S
Production of biotech therapeutics in Escherichia coli involves protein expression as insoluble inclusion bodies that need to be denatured and the resulting protein refolded into the native structure. In this paper, we apply a Quality by Design approach using Design of Experiments for optimization of the refolding process for a recombinant biotech therapeutic, granulocyte colony stimulating factor. First, risk analysis was performed to identify process parameters that require experimental examination. Next, the chosen parameters were examined using a fractional factorial screening design. Based on the results of this study, parameters that have significant effect on refold yield and product quality were identified and examined using a full factorial Design of Experiments for their interactions. The final model was statistically significant and delivered a refolding yield of 77%. Further, kinetics of refolding was evaluated under optimal conditions and was found to be of first order with a rate constant of 0.132/min. Design space was established for the three parameters for a given permissible range of yield, protein concentration, and purity. The primary objective of this paper is to provide a roadmap for implementing Quality by Design for development of a protein refolding step.
The objective of this work is to elucidate various essential drugs in the Brazil, Russia, India, China and South Africa (BRICS) countries. It discusses the opportunities and challenges of the existing biotech infrastructure and the production of drugs and vaccines in member states of the BRICS. This research is based on a systematic literature review between the years 2000 and 2014 of documents retrieved from the databases Embase, PubMed/Medline, Global Health, and Google Scholar, and the websites of relevant international organizations, research institutions and philanthropic organizations. Findings vary from one member state to another. These include useful comparison between the BRICS countries in terms of pharmaceuticals expenditure versus total health expenditure, local manufacturing of drugs/vaccines using technology and know-how transferred from developed countries, and biotech entrepreneurial collaborations under the umbrella of the BRICS region. This study concludes by providing recommendations to support more of inter collaborations among the BRICS countries as well as between BRICS and many developing countries to shrink drug production costs. In addition, this collaboration would also culminate in reaching out to poor countries that are not able to provide their communities and patients with cost-effective essential medicines.
In the early 1980s several prominent scientists left the hallowed halls of respected universities seeking to exploit the revolution occurring in biology in an environment devoid of the bureaucratic and political confines of academia. The emergence of the biotechnology industry has been marked by both spectacular failures and success stories. Genentech was founded in 1976 by biochemist Herbert Boyer and venture capitalist Robert Swanson and went public in 1980. In 1995 Genentech merged with Roche Holdings Ltd., of Basel Switzerland. Distinguished from other biotech companies by the varied array of products it has brought to market, Genentech has also developed a unique corporate culture embodying many traditional academic values. Just as Genentech went public in 1980, Arthur D. Levinson, PhD, finished a post-doctoral appointment in Michael Bishop's lab at the University of California, San Francisco. Despite the disapproval of colleagues, he joined the fledgling company as a senior scientist. Working his way though the ranks, Levinson became Vice President of Research Technology in 1989 and was named President and CEO in 1995. Interviewed at the sprawling corporate headquarters in South San Francisco, Levinson reflected on the process of high risk science, the benefits of the private sector, and the changing relationship between biotech companies and the academic world.
Teng, Paul P S
Of the 102 million hectares that made up the global area of biotech crops in 2006, less than 8% (7.6 million ha) were in Asia. Three biotech crops are currently planted in significant areas in four Asian countries with government regulatory approval; namely, cotton, corn (maize), and canola. However, the amount of GM crop material imported into the Asian region for processing into food and animal feed is very substantial, and almost every country imports GM food. The issues which concern Asian scientists, regulators, and the lay public resemble those of other regions - biosafety, food safety, ethics and social justice, competitiveness, and the "EU" trade question. Most Asian countries now have regulatory systems for approving the commercialization of GM crops, and for approving food safety of GM crops. In Asia, because of the varied cultures, issues concerning the use of genes derived from animals arouse much emotion for religious and diet choice reasons. Because many Asian producers and farmers are small-scale, there is also concern about technology dependency and to whom the benefits accrue. All consumers surveyed have expressed concern about potential allergenic and long-term toxic effects, neither of which is grounded on scientific facts. Because of Asia's growing demand for high volumes of quality food, it is likely that GM crops will become an increasing feature of our diet.
胡继银; 陈俊兴; 李柄华; 唐奕; 刘家龙
SIRAJ, derived from SIRAJ-A(CMS line) and SIRAJ-R(restorer line) , both of which are developed by the RB Biotech Sdn. Bhd. , Malaysia, is a new hybrid rice variety for tropical areas. It is characteristic of fine grain quality, high yield, strong disease resistance and suitable maturity for the tropics. In March, 2010, it was certified and released to commercial production in Malaysia and became the first hybrid rice variety registered local-ly in Malaysia. In the paper, the breeding procedure, main characteristics and techniques for high-yielding cultiva-tion and hybrid seed production of SIRAJ were related in detail.%SIRAJ是马来西亚RB Biotech Sdn.Bhd.用自育的三系不育系SIRAJ -A与恢复系SIRAJ -R配组育成的热带杂交水稻新组合,具有米质优、产量高、抗性较强、熟期适宜、适合热带栽培等特点,2010年3月通过马来西亚国家审定,为马来西亚第1个通过审定的杂交水稻组合.介绍了其选育过程、主要特征特性及栽培、制种技术要点.
Learning communities and their strategies for enrolling cohort groups of students in a common set of classes organized around a theme or linked with residence life have come to light over the past twenty years. However, living-learning communities (LLC) and their role in retention, engagement, and intellectual development for engineering and science students have yet to be fully explored. What aspects of a LLC are most beneficial to science and engineering students? What are the learning needs of engineering and science students that are best met with LLCs? These questions were the basis for assessment of a new LLC program developed at Washington State University specifically to increase retention, academic achievement, and engagement of engineering and science students. A first-year semester-long pilot LLC program was developed at Washington State University specifically for entering engineering majors. The program was expanded the following year to include biotech science majors. The first LLC had 55 self-selected engineering participants. Students were housed in the same residence hall, registered for three common classes, and participated in a non-credit bearing weekly peer-facilitated study group. The second year 81 students self-selected into the program; 59 engineering and 22 biotech majors. Students were housed in a common residence hall and registered for three common classes. Students participated in a two-credit freshman seminar class instead of the once-weekly study group used the previous year. Results indicate students were engaged with peers and in college activities, had mixed academic improvement, and engineering students were retained at higher rates in their major when compared to non-participating peers and biotech participants. Second year LLC students had higher grade averages than comparison peers despite lower incoming preparedness. Higher engagement levels were confirmed by triangulation with national survey comparisons, observations, focus
Patrick Buerger; Caroline Hauxwell; David Murray
Nucleopolyhedrovirus (NPV) has become an integral part of integrated pest management (IPM) in many Australian agricultural and horticultural crops. This is the culmination of years of work conducted by researchers at the Queensland Department of Primary Industries and Fisheries (QDPI&F) and Ag Biotech Australia Pty Ltd. In the early 1970's researchers at QDPI&F identified and isolated a virus in Helicoverpa armigera populations in the field. This NPV was extensively studied and shown to be highly specific to Helicoverpa and Heliothis species. Further work showed that when used appropriately the virus could be used effectively to manage these insects in crops such as sorghum, cotton, chickpea and sweet corn. A similar virus was first commercially produced in the USA in the 1970's. This product, Elcar(R), was introduced into Australia in the late 1970's by Shell Chemicals with limited success. A major factor contributing to the poor adoption of Elcar was the concurrent enormous success of the synthetic pyrethroids. The importance of integrated pest management was probably also not widely accepted at that time. Gradual development of insect resistance to synthetic pyrethroids and other synthetic insecticides in Australia and the increased awareness of the importance of IPM meant that researchers once again turned their attentions to environmentally friendly pest management tools such NPV and beneficial insects. In the 1990's a company called Rhone-Poulenc registered an NPV for use in Australian sorghum, chickpea and cotton. This product, Gemstar(R), was imported from the USA. In 2000 Ag Biotech Australia established an in-vivo production facility in Australia to produce commercial volumes of a product similar to the imported product. This product was branded, ViVUS(R), and was first registered and sold commercially in Australia in 2003. The initial production of ViVUS used a virus identical to the American product but replicating it in an Australian Helicoverpa
T. M. Manjunath
Full Text Available In 2009, transgenic crops were grown on 134 million hectares in 25 countries, including India, in six continents by about 14million farmers, marking an 80-fold increase in the area since their first commercialization on 1.7 m ha in the USA and fiveother countries in 1996. The dominant transgenic traits were herbicide tolerance and insect resistance, deployed either alone orboth stacked in the same plant. A recent survey of the global impact of biotech crops estimated that in 2008 alone, the totalcrop production gain globally for the 4 principal biotech crops - maize, soybean, cotton and canola - was 29.6 million metrictons while the net economic benefit to the biotech farmers was US$ 9.2 billion. The cumulative benefits for the period 1996-2008 were yield gains of 167 million tons and economic returns of US$ 51.9 billion. In India, the area planted with Bt-cottonincreased significantly from year to year since its introduction in 2002 and reached 8.4 million hectares in 2009. The overallbenefits from Bt-cotton included an yield increase of up to 63% due to effective control of bollworms, pesticide reduction by50%, net profit to farmers up to Rs.10,000/hectare and turned India from an importer to a major exporter of cotton. Theseindicate that biotechnology has made significant contributions to higher productivity, lower costs of production and increasedeconomic benefits and that it has enormous potential for the future with new traits, events and crops. Over 60 countries,including India, are engaged in research on about 55 crop species to incorporate transgenes to bestow various traits such asresistance to pests, diseases or herbicides; tolerance to environmental stresses like drought, cold or salinity; enhanced cropyields, nutrition or shelf-life, etc. However, unreasonable opposition to biotechnology and undue delays in regulatoryapprovals are some of the major challenges that need to be addressed so as to make full use of this technology which
吴梧桐; 王友同; 吴文俊
根据最新信息资料，评价了生物技术产业在国民经济发展中的重要地位，重点介绍了生物技术产业市场发展状况，对于了解国内外生物技术发展动态与客观决策具有参考价值。%Based on a thorough review，authors analized and categorized thetrend for the development on biotech-drugs and biopharmaceuticals market，also evaluated the importance of biotechnology in the national economic of China and illustrated their opinion on the direction of development on biopharmaceutical market and biophar maceutical industry in China.
TENG XiaoKun; XIAO HuaSheng
DNA microarray and next-generation DNA sequencing technologies are important tools for high-throughput genome research, in revealing both the structural and functional characteristics of genomes. In the past decade the DNA microarray technologies have been widely applied in the studies of functional genomics, systems biology and pharmacogenomics. The next-generation DNA sequenc-ing method was first introduced by the 454 Company in 2003, immediately followed by the establish-ment of the Solexa and Solid techniques by other biotech companies. Though it has not been long since the first emergence of this technology, with the fast and impressive improvement, the application of this technology has extended to almost all fields of genomics research, as a rival challenging the existing DNA microarray technology. This paper briefly reviews the working principles of these two technologies as well as their application and perspectives in genome research.
Scupola, Ada; Steinfield, Charles; Lopez-Nicolas, Carolina
This study explores how some uses of ICTs, as well as having social capital and other means of access to knowledge resources, are related to company performance in a knowledge-intensive business cluster. Data were collected through a survey of companies in the Medicon Valley biotech region located...... in Denmark and Southern Sweden. Responding companies included established producers of biotechnology-related products as well as small biotechnology start-up firms emphasizing research and development. The results suggest that when ICT use was aimed at accessing and enhancing human and intellectual capital...... to information and opportunity predicted company performance, particularly for small start-up companies. The pattern of results complements prior work that establishes the importance of social capital in regional business clusters by demonstrating how certain ICT uses complement personal relationships to enhance...
Steinfield, Charles; Scupola, Ada; López-Nicolás, Carolina
This study explores how some kinds of ICT uses, as well as social capital and other means of access to knowledge resources, are related to company performance in a knowledge-intensive business cluster. Data were collected through a survey of companies in the Medicon Valley biotech region located...... in Denmark and Southern Sweden. Responding companies included established producers of biotechnology-related products as well as small biotechnology start-up firms emphasizing research and development. The results suggest that when ICT use was aimed at accessing and enhancing human and intellectual capital...... to information and opportunity predicted company performance, particularly for small start-up companies. The pattern of results complements prior work that establishes the importance of social capital in regional business clusters by demonstrating how ICT use complements personal relationships to enhance...
DNA microarray and next-generation DNA sequencing technologies are important tools for high-throughput genome research,in revealing both the structural and functional characteristics of genomes.In the past decade the DNA microarray technologies have been widely applied in the studies of functional genomics,systems biology and pharmacogenomics.The next-generation DNA sequencing method was first introduced by the 454 Company in 2003,immediately followed by the establishment of the Solexa and Solid techniques by other biotech companies.Though it has not been long since the first emergence of this technology,with the fast and impressive improvement,the application of this technology has extended to almost all fields of genomics research,as a rival challenging the existing DNA microarray technology.This paper briefly reviews the working principles of these two technologies as well as their application and perspectives in genome research.
Lund, Christian Have
GALACTURONOSYLTRANSFERASE1 (GAUT1) and GAUT7 has beesn identified and is essential for pectin biosynthesis. Interestingly, GAUT1 has been shown to be proteolytic processed from its transmembrane anchor domain and its catalytic domain is retained by GAUT7, thus ensuring biosynthesis of HG in the Golgi apparatus. Many...... methods exist in identifying protein-protein interaction (PPI) but many of these are developed for other organisms than plants and are most applicable for PPI detection in other organelles than the Golgi apparatus where pectin biosynthesis occurs. In this work, different PPI detection methods are examined...... for their ability to detect PPI inside the Golgi lumen. The first method tested was the commercially available splitubiquitin system from Dualsystems Biotech AG. This was applied to test binary interactions between proteins involved in HG and Rhamnogalacturonan I (RG-I) biosynthesis (see Manuscript II...
Tacket, Carol O; Levine, Myron M
Typhoid fever remains an important public health problem in many parts of the world. Despite the availability of oral Ty21a (Vivotif; Berna Biotech) and parenteral Vi polysaccharide vaccine (Typhim Vi; Aventis Pasteur), improved typhoid fever vaccines have been sought. These include a series of vaccine candidates developed at the Center for Vaccine Development, University of Maryland, based on attenuation of Salmonella enterica serovar Typhi by deletions in the aroC, aroD, and htrA genes. These vaccine candidates, designated "CVD 908," "CVD 908-htrA," and "CVD 909," have been developed and tested in volunteers with variable success. This review summarizes the clinical data that directed the logical progression of this vaccine development strategy.
Patois, E; Capelle, M A H; Gurny, R; Arvinte, T
The stability of different seasonal influenza vaccines was investigated by spectroscopy and microscopy methods before and after the following stress-conditions: (i) 2 and 4 weeks storage at 25°C, (ii) 1 day storage at 37°C and (iii) one freeze-thaw cycle. The subunit vaccine Influvac (Solvay Pharma) and the split vaccine Mutagrip (Sanofi Pasteur) were affected by all stresses. The split vaccine Fluarix (GlaxoSmithKline) was affected only by storage at 25°C. The virosomal vaccine Inflexal V (Berna Biotech) was stable after the temperature stresses but aggregated after one freeze-thaw cycle. This study provides new insights into commercial vaccines of low antigen concentration and highlights the importance of using multiple techniques to assess vaccine stability.
Privalle, Laura S; Chen, Jingwen; Clapper, Gina; Hunst, Penny; Spiegelhalter, Frank; Zhong, Cathy X
"Genetically modified" (GM) or "biotech" crops have been the most rapidly adopted agricultural technology in recent years. The development of a GM crop encompasses trait identification, gene isolation, plant cell transformation, plant regeneration, efficacy evaluation, commercial event identification, safety evaluation, and finally commercial authorization. This is a lengthy, complex, and resource-intensive process. Crops produced through biotechnology are the most highly studied food or food component consumed. Before commercialization, these products are shown to be as safe as conventional crops with respect to feed, food, and the environment. This paper describes this global process and the various analytical tests that must accompany the product during the course of development, throughout its market life, and beyond.
Galis, Vasilis; Tzokas, Spyros; Tympas, Aristotle
Against what the dominant rhetoric of globalization would led us to assume, we live in a world that is overwhelmed by the presence of borders. Erasing some borders, so as to allow for easier and increased flow of commodities, was frequently coupled by the introduction of additional borders, to di...... against superior EU and Greek detection and ‘push-back’ technology....... has focused on their reinforcement through the deployment of all kinds of state-of-the-art policing technology, from ICT to biotech. Our research makes a notice of this literature but seeks to approach the technological borders of the EU through the study, also, of the technology that migrants used...... displaced bodies and disabling socio-material barriers. In this sense, dis/ability cannot be detached from the performative role of policing technology. Instead, however, of staying at something like the technology of a patrolling EU police helicopter with electronic eyes, we want to study how this state...
This presentation will fill the total picture of this conference between fisheries and aquaculture, blue biotech and bioconservation, by considering the optimal processing technology of marine resources from the raw material until the seafood reaches the plate of the consumer. The situation today...... must be performed such that total traceability and authenticity of the final products can be presented on demand. The most important aspects to be considered within seafood technology today are safety, healthy products and high eating quality. Safety can be divided into microbiological safety...... and not presenting any safety risk per se. Seafood is healthy due to the omega-3 fatty acids and the nutritional value of vitamins, peptides and proteins. The processing technology must however be performed such that these valuable features are not lost during production. The same applies to the eating quality. Any...
Kinch, Michael S
Since the 1970s, biotechnology has been a key innovator in drug development. An analysis of FDA-approved therapeutics demonstrates pharmaceutical companies outpace biotechs in terms of new approvals but biotechnology companies are now responsible for earlier-stage activities (patents, INDs or clinical development). The number of biotechnology organizations that contributed to an FDA approval began declining in the 2000s and is at a level not seen since the 1980s. Whereas early biotechnology companies had a decade from first approval until acquisition, the average acquisition of a biotechnology company now occurs months before their first FDA approval. The number of hybrid organizations that arise when pharmaceutical companies acquire biotechnology is likewise declining, raising questions about the sustainability of biotechnology.
Monsores, Natan; Lopes, Cecilia; Bezerra, Edilnete Maria Bessa; Silva, Natasha Lunara
Therapeutic tourism is a recent phenomenon in public health and has had repercussions among people with disabilities. Virtual social networks have enabled people to organize themselves to discover ways and means of seeking unconventional treatments in China. In this context, foreign biotech companies have offered experimental cell treatment therapies. In this work, netnography (conducting ethnographic research online) was conducted on the blogs of 58 people who organized campaigns to carry out treatment in China. In the analysis it was found that the main motivation for mobilization of resources and people in order to submit a disabled child to a treatment with stem cells without scientific proof is the rhetoric of hope promoted by stem cell laboratories. The conclusion drawn is that due to the ethical, legal and health implications, debate on the subject should be broadened in order to protect vulnerable individuals against inadvertent exposure to health risks due to treatments without proven control or rigor.
This article deals with the key technologies in straw ensilage mechanized production.Experiments were made in this field.The results indicate that this project can meet the equipment technology targets and the requirement of product quality.It is pragmatic and advanced in biotech and mechanized processing technology.%介绍秸秆青贮机械化生产项目的关键技术,对秸秆青贮产成品进行机械化设备性能试验、生产试验与产成品饲用,分析试验结果,证实该项目能够同时满足设备技术指标和产成品质量要求,其生物处理技术和机械加工技术具有实用性、科学性和先进性。
Full Text Available Nanotechnology is on its way to make a big impact in Biotech, Pharmaceutical and Medical diagnostics sciences. Nanotechnology holds a tremendous potential when it applied in the fields of drug delivery. In this review it has been discussed how nanotechnology can implemented to design formulations which can effectively carry drug molecule to the targeted cell organelles. Introduction of certain functional groups or addition of surface active agents may alter the characteristics of the carrier molecule, thus increasing the sensitivity to site selection of the carrier. It has been predicted that in the near future, nanoparticles with the ability of carrying multiple drug molecules, will be designed. They can maintain the delivery of drugs at specific time interval.
Minssen, Timo; Nilsson, David
invigorated U.S. debate on patent eligibility, referring inter alia to the 2010 U.S. Supreme Court decision in Bilski v. Kappos and the pending certiorari in Prometheus v. Mayo (1). Before this background, Part I recited the complex procedural history of AMP v. USPTO (2) and summarized the underpinnings...... and so-called "Beauregard"- claims, but also for biotech-claims directed to personalized medicine, biological correlations and compounds containing biological information. As far as possible, this part will also incorporate new developments that can be expected in the coming months, such as the pending...... certiorari decision in AMP v. USPTO and the pending Supreme Court decision in Prometheus v. Mayo. Part IV, which is to be published in issue 4, will finally offer a broader discussion of the recent US patent-eligibility developments from an innovation policy perspective including brief references to recent...
Yildiz-Ozturk, Ece; Yesil-Celiktas, Ozlem
Biomicrofluidics is an emerging field at the cross roads of microfluidics and life sciences which requires intensive research efforts in terms of introducing appropriate designs, production techniques, and analysis. The ultimate goal is to deliver innovative and cost-effective microfluidic devices to biotech, biomedical, and pharmaceutical industries. Therefore, creating an in-depth understanding of the transport phenomena of cells and biomolecules becomes vital and concurrently poses significant challenges. The present article outlines the recent advancements in diffusion phenomena of cells and biomolecules by highlighting transport principles from an engineering perspective, cell responses in microfluidic devices with emphases on diffusion- and flow-based microfluidic gradient platforms, macroscopic and microscopic approaches for investigating the diffusion phenomena of biomolecules, microfluidic platforms for the delivery of these molecules, as well as the state of the art in biological applications of mammalian cell responses and diffusion of biomolecules.
Jahangir Yadollahi Fars
Full Text Available Biotechnology industry has a special place among novel industries. The majority of biotech companies are start-ups or small companies that have been working for several years yet are not profitable. Evidences showed that firms and researchers have problems in turning academic findings to commercial revenue and there is problem in commercialization process and choosing method of the exploitation academic opportunities or choosing proper commercialization strategy in this industry. In this study, firstly, the local determinants of commercialization strategy in 41 Iranian young biotechnology companies were identified through interview and then a questionnaire was prepared integrating these determinants and the rest of them exist in literature and was distributed among a larger sample in order to obtain the integrity. Finally, after analyzing the questionnaires, the local determinants of commercialization strategies for Iranian researcher in biotechnology sector were identified.
On the 15-17th of May 2013, about 120 scientists, postdoctoral fellows and professors representing renowned academic institutes and senior scientists and executives from small biotechs, contract research organizations (CROs) and Big Pharma companies, gathered at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland for the 4th international conference on Modern Vaccines and Adjuvants Formulation. Despite this relative small number, the speakers and attendees covered together a very broad field of expertise. Indeed, experts in microbiology, immunology, biochemistry, formulation, virus and nanoparticle characterization, vaccine production, quality control as well as regulatory professionals attended the conference and were able to present their works and discuss new developments within the field of vaccine and adjuvant development, characterization and approval process. This broad diversity was a highpoint of the conference and allowed for a stimulating environment and underlined the complexity of the challenges that the field currently faces in order to develop better or completely new vaccines and adjuvants.
Madsen, Henning; Neergaard, Helle
It has long been recognised that social capital in the shape of network relationships plays a significant role in the internationalisation process of a business. This research seeks to further the discussion of how social capital influences the early internationalization of new technology...... no international activities. Based on statistical analysis it elucidates the relationship among a number of factors related to social capital which may influence the internationalization process. These factors include the number and types of contacts as well as how these contacts are utilized. The results indicate......-based ventures. It is based on survey data provided by 98 entrepreneurs and in-depth interviews with the founders of 24 ventures in the Danish IT/communication and biotech/medico industries. The paper focuses on contrasting new ventures already operating on the international scene with those that have...
Full Text Available As diseases continue to spread around the globe, pharmaceutical and biotech companies continue to search for new and better drugs to treat them. Most of these companies have realised that useful compounds for these purposes may be found in the natural resources that indigenous and local communities use. And yet, even though the importance of these biological resources to global health and economic livelihood is well recognised, the legal ownership and control of this traditional knowledge is still very controversial. This article undertakes a comparative analysis of American and European, as well as international legal regulations on patent law and traditional knowledge. Key questions include: What is traditional knowledge? How have the national patent laws of these countries treated the protection of plant variety and plant genetic resources? What are the existing international standards for patents, and what implications do they have for protecting traditional knowledge? And finally, what protection systems are emerging for the future?
This paper explores how Front End Innovation (FEI) is supported among companies of different nationality within the context of Pharmaceutical R&D. The present study is carried out in order to contribute to the development of a clearer understanding of active facilitation of innovation management...... and front end innovation in theory and practice. I aim to show how different aspects of company size, type and nationality affect the way innovation management and FEI is supported within organizations. This is examined through an in-depth case study of the Danish pharmaceutical company, H. Lundbeck A....../S, and a comparative study including seven European and American Biotech and Pharmaceutical companies. The findings from the study reveal a number of similarities and differences in innovation management and FEI support among the different companies and present propositions of important aspects to consider...
Joshi, Swati; Satyanarayana, Tulasi
The discovery of a novel enzyme from a microbial source takes anywhere between months to years, and therefore, there has been an immense interest in modifying the existing microbial enzymes to suit the present day needs of the industry. The redesigning of industrially useful enzymes for improving their performance has become a challenge because bioinformatics databases have been revealing new facts on a day-to-day basis. Modification of the existing enzymes has become a trend for fine tuning of biocatalysts in the biotech industry. Hydrolases are employed in pharmaceutical, biofuel, detergent, food and feed industries that significantly contribute to the global annual revenue, and therefore, the emphasis has been on engineering them. Although a large data is accumulating on making alterations in microbial enzymes, there is a lack of definite information on redesigning industrial enzymes. This review focuses on the recent developments in improving the characteristics of various biotechnologically important enzymes.
Coumou, Hilde; van der Werf Kulichova, Z.; Wehrmann, C.
making is dependent on their view of the way science and decision making relate to each other. The respondents who are currently active in policy making seem to be driven by commitment to the public good. However, many respondents feel social pressure from environmental NGOs to withdraw from engagement......Policy making regarding application of agricultural biotechnology has been controversial. This study investigates what determines the motivation of European biotech scientists to actively participate in policy making. To do this, a conceptual framework was developed based on the Theory of Planned...... in GMO policy making. Furthermore, the respondents judge themselves more competent to take an informing role than a participating role. Finally, many of the scientists feel that encouragement by their own research institute or some science-policy organization increases their ability to involve in policy...
Full Text Available Knowledge about the crop biology of economic crops in Africa is needed for regulators to accurately review dossiers and conduct comprehensive environmental risk assessments (ERA. This information allows regulators to decide whether biotech crops present a risk to biodiversity, since crossing between domesticated crops and their wild relatives could affect the adaptations of the wild species. The criteria that should be used in the evaluation of African crops for environmental risk assessment (ERA include: growth habit, centre of origin, centre of genetic diversity, proximity of wild relatives, inter-fertility, mode of pollen dispersal, length of pollen viability, mating system, invasiveness, weediness, mode of propagation, mode of seed dispersal and length of seed dormancy. In this paper, we discuss the crops being genetic engineered in Africa and describe the crop biology of those with native relatives.
Kwiatek, K; Mazur, M; Sieradzki, Z
Progress, which is brought by new advances in modern molecular biology, allowed interference in the genome of live organisms and gene manipulation. Introducing new genes to the recipient organism enables to give them new features, absent before. Continuous increase in the area of the biotech crops triggers continuous discussion about safety of genetically modified (GM) crops, including food and feed derived from them. Important issue connected with cultivation of genetically modified crops is a horizontal gene transfer and a bacterial antibiotic resistance. Discussion about safety of GM crops concerns also food allergies caused by eating genetically modified food. The problem of genetic modifications of GM crops used for livestock feeding is widely discussed, taking into account Polish feed law.
S. M. Shulga
Full Text Available Energy and environmental crisis facing the world force us to reconsider the effectiveness or find an alternative use of renewable natural resources, especially organic «waste» by using environmentally friendly technologies. Microbial conversion of renewable resources of biosphere to produce useful products, including biofuels, currently is an actual biotech problem. Anaerobic bacteria of Clostridiaceae family are known as butanol producers, but unfortunately, the microbiological synthesis is currently not economical one. In order to make cost-effective aceton-butanol-ethanol fermentation, solventproducing strains using available cheap raw materials, such as agricultural waste or plant biomass, are required. Opportunities and ways to obtaine economic and ecological processing of lignocellulosic wastes for biobutanol creation are described in the review .
Krzywonos, Małgorzata; Cibis, Edmund; Lasik, Małgorzata; Nowak, Jacek; Miśkiewicz, Tadeusz
The aim of the study was to ascertain the extent to which temperature influences the utilisation of main carbon sources (reducing substances determined before and after hydrolysis, glycerol and organic acids) by a mixed culture of thermo- and mesophilic bacteria of the genus Bacillus in the course of aerobic batch biodegradation of potato stillage, a high-strength distillery effluent (COD=51.88 g O(2)/l). The experiments were performed at 20, 30, 35, 40, 45, 50, 55, 60 and 63 degrees C, at pH 7, in a 5l working volume stirred-tank bioreactor (Biostat B, B. Braun Biotech International) with a stirrer speed of 550 rpm and aeration at 1.6 vvm. Particular consideration was given to the following issues: (1) the sequence in which the main carbon sources in the stillage were assimilated and (2) the extent of their assimilation achieved under these conditions.
Full Text Available The financial sector is living a profound crisis in order to keep pace with the continuous technological breakthroughs that come out daily, while other sectors seem to be historically more growth-by-innovation-based (e.g., the pharma/biotech sector. This work focuses on an interdisciplinary approach to innovation, and on insights that the banking sector can draw from the pharmaceutical one. Hence, a unique dataset has been built, and it collects information on the most relevant players for both the fields. Different indicators have been created as well in order to empirically test whether the financial industry is actually less innovative with respect to the pharmaceutical one, and to understand the best growing strategy for the banking industry. The results confirm that there is an innovation gap between the two industries, as well as identify the corporate venture capital as the best mean to drive business growth through innovation.
Geoff Burnstock's remarkable insight and tenacity has established the area of purinergic research as a bona fide target for drug discovery. While efforts in P1 receptor-based medicinal chemistry and biology efforts over the past 25 years have not reached the level of success that the pharmaceutical industry investment may have anticipated, the P2 area, with knowledge of the selective localization of members of the P2X and P2Y family members and data from transgenic knockouts, has identified several potential therapeutic areas of major promise including cystic fibrosis, chronic bronchitis, male contraception and neurodegeneration. In addition, interest in the potential of purinergic therapeutics has extended outside the major pharmaceutical companies to the 'biotech industry' resulting in an environment where the inherent risks of 'first in field' in a therapeutic area may be more appropriately nurtured.
Binnie, Ian; Park-Thompson, Vanessa
In June 2013, the U.S. Supreme Court rendered a controversial ruling that naturally occurring DNA segments are "products of nature" and therefore not patentable subject matter. At this intersection between science and law, in litigation of crucial importance to patients, science, and multibillion-dollar biotech enterprises, the appellate judges sidestepped genetics and engaged in a war of metaphors from diamonds to chocolate chip cookies. This case is not an outlier. Apprehensive judges and juries in both Canada and the United States find many convenient excuses to avoid coming to grips with the underlying science in patent cases. But this is simply not acceptable. Legal rulings must be, and must seem to be, well grounded, as a matter of both law and science. The legitimacy of court decisions in the eyes of the stakeholders and the broader public depends on it.
Read, E K; Shah, R B; Riley, B S; Park, J T; Brorson, K A; Rathore, A S
Implementing real-time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: "variability is managed by the process" and "product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions." The first part of the paper presented an overview of PAT concepts and applications in the areas of upstream and downstream processing. In this second part, we present principles and case studies to illustrate implementation of PAT for drug product manufacturing, rapid microbiology, and chemometrics. We further present our thoughts on how PAT will be applied to biotech processes going forward. The role of PAT as an enabling component of the Quality by Design framework is highlighted. Integration of PAT with the principles stated in the ICH Q8, Q9, and Q10 guidance documents is also discussed.
Beukel, Karin; Valentin, Finn
Patent strategies are endogenous to firm appropriability. However, to what extent does firm’s R&D teams’ engagement with patent experts influence the value of patents? We estimate the relationship between firm’s R&D use of patent functions on patent value in Biotech firms. Controlling...... for characteristics of scientific team, firm effects, and other patent value indicators, we find that having a firm specific (in-house) internal patent function is a driver of patent value. In addition, we find that the way in which patent functions create patent value differs dependent on whether the firm has...... internal patent function or not. In-house patent functions create value through narrow patents, whereas, firms with no in-house patent function create valuable patents by the use of broader scoped patents. Our results point to a strong effect of firm specific patent functions, but also explain how firms...
Burke, Paul F.; Reitzig, Markus
The increasing number of patent applications worldwide and the extension of patenting to the areas of software and business methods have triggered a debate on "patent quality". While patent quality may have various dimensions, this paper argues that consistency in the decision making on the side...... of the patent office is one important dimension, particularly in new patenting areas (emerging technologies). In order to understand whether patent offices appear capable of providing consistent assessments of a patent's technological quality in such novel industries from the beginning, we study the concordance...... of the European Patent Office's (EPO's) granting and opoposition decisions for individual patents. We use the historical example of biotech patens filed between 1978 until 1986, the early stage of the industry. Our results indicate that the EPO shows systematically different assessments of technological quality...
Murphy, Amanda; Stramiello, Michael; Lewis, Stacy; Irving, Tom
This review introduces patents and trade secrets, the two mechanisms that U.S. law provides inventors to protect their inventions. These mechanisms are mutually exclusive: One demands disclosure and the other calls for concealment. Many biotechnology innovators opt for patents, which grant legal, time-limited monopolies to eligible inventions.To obtain a patent in the United States, an invention must be useful to the public and made or altered by the hand of man. It must then clear the hurdles of novelty and nonobviousness. If an invention can do that, obtaining a patent becomes a matter of form: Who qualifies as an inventor? Does the application demonstrate possession, stake a clear claim to the protection sought, and enable "ordinary" colleagues to replicate it? Has the inventor purposely withheld anything? This review addresses each of these hurdles as they apply to biotech inventions.
Tidwell, J Lille; Liotta, Lance A
Patents are designed to protect and encourage creativity and innovation. Patenting a biomedical discovery can be a requirement before a pharmaceutical company or biotech entity will invest in the lengthy and costly clinical testing necessary to achieve patient benefit. Although scientists and clinicians are well versed in research publication requirements, patent descriptions and claims are formatted in a manner quite different from a research paper. Patents require (a) a series of logical statements clearly delineating the boundaries of the novel aspects of the invention and (b) sufficient disclosure of the invention so that it can be reproduced by others. Patents are granted only for inventions that meet three conditions: novelty, nonobviousness, and usefulness. This chapter provides basic guidelines and definitions of technology transfer: inventions, inventorship, and patent filing, which are summarized using a question and answer format.
Global pharmaceutical and biotechnology companies have been building increasingly on the skills and services offered by Indian biotech companies through strategic collaborative partnerships and alliances to fuel their in-house discovery and development pipelines. With the exception of generic press releases, however, very little has been published on the process and progress of drug discovery itself, such as the targets or modes of action involved, nor on the scientific output of such collaborations, and therefore on new chemical entities coming out of India through research collaborations. This Essay provides an analytical review of recent patents, patent applications, and peer-reviewed publications of major research alliances. It aims at highlighting their scientific output as well as the considerable bandwidth of targets and therapeutic areas involved.
Isabelle M. Carbonell
Full Text Available This paper examines the ethics of big data in agriculture, focusing on the power asymmetry between farmers and large agribusinesses like Monsanto. Following the recent purchase of Climate Corp., Monsanto is currently the most prominent biotech agribusiness to buy into big data. With wireless sensors on tractors monitoring or dictating every decision a farmer makes, Monsanto can now aggregate large quantities of previously proprietary farming data, enabling a privileged position with unique insights on a field-by-field basis into a third or more of the US farmland. This power asymmetry may be rebalanced through open-sourced data, and publicly-funded data analytic tools which rival Climate Corp. in complexity and innovation for use in the public domain.
Full Text Available Since the 1970s, the establishment and development of the biotech industry has improved exponentially, allowing the commercial production of biopharmaceutical proteins. Nowadays, new recombinant protein production is considered a multibillion-dollar market, in which about 25% of commercial pharmaceuticals are biopharmaceuticals. But to achieve a competitive production process is not an easy task. Any production process has to be highly productive, efficient and economic. Despite that the perfect host is still not discovered, several research groups have chosen Pichia pastoris as expression system for the production of their protein because of its many features. The attempt of this review is to embrace several research lines that have adopted Pichia pastoris as their expression system to produce a protein on an industrial scale in the health care industry.
Meredith G Schafer
Full Text Available Concerns regarding the commercial release of genetically engineered (GE crops include naturalization, introgression to sexually compatible relatives and the transfer of beneficial traits to native and weedy species through hybridization. To date there have been few documented reports of escape leading some researchers to question the environmental risks of biotech products. In this study we conducted a systematic roadside survey of canola (Brassica napus populations growing outside of cultivation in North Dakota, USA, the dominant canola growing region in the U.S. We document the presence of two escaped, transgenic genotypes, as well as non-GE canola, and provide evidence of novel combinations of transgenic forms in the wild. Our results demonstrate that feral populations are large and widespread. Moreover, flowering times of escaped populations, as well as the fertile condition of the majority of collections suggest that these populations are established and persistent outside of cultivation.
Murthy, Hosakatte Niranjana; Georgiev, Milen I; Park, So-Young; Dandin, Vijayalaxmi S; Paek, Kee-Yoeup
Plant cell, tissue and organ cultures (PCTOC) have become an increasingly attractive alternative for the production of various high molecular weight molecules which are used as flavourings, fragrances, colouring agents and food additives. Although PCTOC products are cultivated in vitro in a contamination free environment, the raw material produced from PCTOC may contain many components apart from the target compound. In some cases, PCTOC raw materials may also carry toxins, which may be naturally occurring or accumulated during the culture process. Assessment of the safety of PCTOC products is, therefore, a priority of the biotech industries involved in their production. The safety assessment involves the evaluation of starting material, production process and the end product. Before commercialisation, PCTOC products should be evaluated for their chemical and biological properties, as well as for their toxicity. In this review, measures and general criteria for biosafety evaluation of PCTOC products are addressed and thoroughly discussed.
Gjerdrum Pedersen, Esben Rahbek; Hove Henriksen, Morten; Frier, Claus
Purpose – The objective of the paper is to describe and discuss how the biotech company Novozymes integrates stakeholder thinking into everyday sustainability practices. Design/methodology/approach – The paper is based on first-hand experiences as well as secondary information from Novozymes......' stakeholder-oriented sustainability activities. Findings – The paper illustrates how a company is striving to transform the general stakeholder principles into concrete, manageable actions. Moreover, the paper describes some of the needs, challenges, and paradoxes experienced by an organisation that is trying...... to make sense of stakeholder thinking. Originality/value – The contribution of this paper is to provide a detailed analysis of how various stakeholder relations management methods can be used in practice to integrate sustainability in an organisation....
Genomics has brought biology, medicine, agriculture, psychology, anthropology, and even philosophy to a new threshold. In this new context, the question about "what is human in humans" may end up being answered by geneticists, specialists of technoscience, and owners of biotech companies. The author defends, in this article, the idea that humanity is at risk in our age of genetic engineering, biotechnologies, and market-geared genetic research; he also argues that the values at the very core of our postgenomic era bring to its peak the science-based ideology that has developed since the time of Galileo, Newton, Descartes, and Harvey; finally, it shows that the bioindustry has invented a new genomythology that goes against the scientific evidence produced by the research in human sciences in which life is interpreted as a language.
In recent years, the number of biotech enterprises in Europe has grown spectacularly, largely fueled by the increasing number of entrepreneurial initiatives from Europe's leading research institutes. The place held on the economic market by these enterprises, is a question that market analysts have been asking themselves since their rapid growth and, more particularly, their over valuation which, at times, has led to the crash of their shares on the stock markets. To be sure, this article does not claim to go into an in-depth financial analysis to explain the details of certain "shipwrecks". Rather, it just would like to provide some useful indications for all those having embarked, or desirous of doing so, in the creation of biomedical enterprises.
Gisler, Monika; Woodard, Ryan
We present a detailed synthesis of the development of the Human Genome Project (HGP) from 1986 to 2003 in order to test the "social bubble" hypothesis that strong social interactions between enthusiastic supporters of the HGP weaved a network of reinforcing feedbacks that led to a widespread endorsement and extraordinary commitment by those involved in the project, beyond what would be rationalized by a standard cost-benefit analysis in the presence of extraordinary uncertainties and risks. The vigorous competition and race between the initially public project and several private initiatives is argued to support the social bubble hypothesis. We also present quantitative analyses of the concomitant financial bubble concentrated on the biotech sector. Confirmation of this hypothesis is offered by the present consensus that it will take decades to exploit the fruits of the HGP, via a slow and arduous process aiming at disentangling the extraordinary complexity of the human complex body. The HGP has ushered other...
Araci, Ismail Emre; Pop, Paul; Chakrabarty, Krishnendu
in the deployment of microfluidic biochips is their low reliability and lack of test techniques to screen defective devices before they are used for biochemical analysis. Defective chips lead to repetition of experiments, which is undesirable due to high reagent cost and limited availability of samples. This paper......Microfluidic biochips are replacing the conventional biochemical analyzers by integrating all the necessary functions for biochemical analysis using microfluidics. Biochips are used in many application areas, such as, in vitro diagnostics, drug discovery, biotech and ecology. The focus...... of this paper is on continuous-flow biochips, where the basic building block is a microvalve. By combining these microvalves, more complex units such as mixers, switches, multiplexers can be built, hence the name of the technology, “microfluidic Very Large-Scale Integration” (mVLSI). A roadblock...
Jørgensen, Michael Søgaard; Andersen, Bente Hessellund
for processing of biomass for biofuels. The alignment with the private car regime is strong, because biofuel enables continuation of fuel-driven vehicles as dominating transportation mode. Danish farmers see manure as important source for biogas while arguing for reduction of climate impact and nuisances from...... a prominent role in several Danish climate and energy plans, alongside with wind and solar energy, and energy savings. There are major controversies about targets for bioenergy with respect to acceptable types, sources and amounts of biomass. Strong path dependency is identified. Energy companies in Denmark...... convert coal fired power plants to biomass in order to sustain the role of these power plants. Their increasing use of imported wood pellets is criticized for increasing greenhouse gas emissions because of fast logging of years of forest growth. A Danish biotech company is developing enzymes...
Andersen, Bente Hessellund; Jørgensen, Michael Søgaard
and the environmental impacts of using bioenergy: Energy companies convert coal fired power plants into imported biomass to sustain the role of these power plants in the transition towards renewable energy, while some NGOs claim that this practice will not reduce emissions. Farmers see slurry as a source for biogas...... and a measure to reduce climate impact and nuisances from slurry, while NGOs fear slurry-based biogas is used as argument for increased animal husbandry. A biotech company develops enzymes for processing of biomass for second generation biofuels, which has obtained some support, while others see this as merely......Danish bioenergy controversies are analysed from a sustainable transition perspective and as a case on industrialized societies’ use of bioenergy as part of the transition away from an energy system built on fossil energy. The analyses are based on the concept of Arena of Development for analyses...
Brazelton, Vincent A; Zarecor, Scott; Wright, David A; Wang, Yuan; Liu, Jie; Chen, Keting; Yang, Bing; Lawrence-Dill, Carolyn J
ABSTRACT Targeted genome editing is now possible in nearly any organism and is widely acknowledged as a biotech game-changer. Among available gene editing techniques, the CRISPR-Cas9 system is the current favorite because it has been shown to work in many species, does not necessarily result in the addition of foreign DNA at the target site, and follows a set of simple design rules for target selection. Use of the CRISPR-Cas9 system is facilitated by the availability of an array of CRISPR design tools that vary in design specifications and parameter choices, available genomes, graphical visualization, and downstream analysis functionality. To help researchers choose a tool that best suits their specific research needs, we review the functionality of various CRISPR design tools including our own, the CRISPR Genome Analysis Tool (CGAT; http://cropbioengineering.iastate.edu/cgat). PMID:26745836
Full Text Available This study examines the moderating role of technology uncertainty on the relationship between team contextual factors of top management support and T-shaped skills with innovation speed. For the purpose of this study, the data were collected from 227 new products from 147 biotechnology firms in Malaysia. The overall results confirmed the moderating effect of technology uncertainty on the relationship between T-shaped skills, as well as top management support with innovation speed. The results further confirmed that under the high technology uncertainty, this effect is higher in comparison to the low and medium uncertainty. This indicates that the effect of top management support and T-shaped skills on innovation speed improves when technology uncertainty increases. On the practical side, the report equips biotech firms with valuable insights to develop effective strategies.
In recent years numerous calls have been made to enhance the social responsibility of biotechnology from both social scientists (e.g. Nowotny et. al. 2001) and political institutions (e.g. Royal Society 2004; U.S. Congress 2003; EEA 2002). The demands vary in form and content: From state incentives...... pressure on the biotech research organizations that find themselves in a jumble of demands to engage themselves with society. Mccarthy and Kelty, for instance, quote a nano-technologist for saying that he is afraid of “too much responsibility” (2010: 407). Based on a laboratory ethnography, this paper...... general public’ or ‘the troops’. The other lab has many diffuse ‘side-activities’ with bio-hackers, government and policy groups, but partly seems to engage in order to stay ahead of policy-makers and protect their core activity, which they find to be ‘basic research’. The paper finally argues...
Full Text Available Microbial alkaline protease has become an important industrial and commercial biotech product in the recent years and exerts major applications in food, textile, detergent, and pharmaceutical industries. By immobilization of microbes in different entrapment matrices, the enzyme produced can be more stable, pure, continuous, and can be reused which in turn modulates the enzyme production in an economical manner. There have been reports in support of calcium alginate and corn cab as excellent matrices for immobilization of Bacillus subtilis and Bacillus licheniformis, respectively. This study has been carried out using calcium alginate, κ-carrageenan, agar-agar, polyacrylamide gel, and gelatin which emphasizes not only on enzyme activity of immobilized whole cells by different entrapment matrices but also on their efficiency with respect to their reusability as first attempt. Gelatin was found to be the best matrix among all with highest enzyme activity (517 U/ml at 24 h incubation point and also showed efficiency when reused.
V. M. Mokrosnop
Full Text Available Microalgae are able to accumulate considerable amounts of tocopherols (up to 4 mg/g dry weight. The content of α-tocopherol to plant oils is low, whereas microalgae contain up to 97% of the tocochromanols that provides high bioactivity. The data about the content of tocopherols in eukaryotic microalgae Dunaliella tertiolecta, Nannochloropsis oculata, Isochrysis galbana, Euglena gracilis, Tetraselmis suecica, Diacronema vlkianum, as well as in the cyanobacterium Spirulina platensis are given in the paper. The largest amounts of tocopherols are synthesized by Euglena gracilis cells at mixotrophic cultivation. The level of tocopherols in microalgae depends on cultivation conditions. Two-stage biotech cultivation techniques, limiting nutrition in some biogenic elements, the introduction of exogenous carbon sources are used to increase the yield of tocopherol from microalgae. The approaches to the genetic transformation of plants leading to higher content of active vitamin E are rewieved as well.
Full Text Available The wave of biotechnology promises has struck not only the developed countries but the developing countries as well. The scientific community in Indonesia is aware of the opportunities and is eager to take an active part in this particular endeavour. Meanwhile resources are required to welcoming the biotechnology era. The need of trained manpower, appropriate infrastructure and equipment, operational and maintenance costs requires serious consideration if a unit or a laboratory is expected to be functional in biotechnology. There is a good opportunity of applying biotechnology in the field of agriculture and industry considering the availability of biological resources in Indonesia. This paper outlines what have been done so far, the difficulties encountered and the efforts made to strengthening biotechnology research in Indonesia.
Schmidt, Mark E; Siemers, Eric; Snyder, Peter J; Potter, William Z; Cole, Patricia; Soares, Holly
The Industry Scientific Advisory Board (ISAB) consists of representatives from the private companies and nonprofit foundations participating as sponsors of Alzheimer's Disease Neuroimaging Initiative (ADNI). Currently 21 companies are represented including pharmaceutical, imaging, and biotech concerns, and two foundations including the Alzheimer's Association. ISAB members meet regularly by teleconference or face-to-face at ADNI meetings and participate in the ADNI Core groups, all administered and organized by the Foundation for the National Institutes of Health. ISAB 'deliverables' include dissemination of information to sponsors, assisting in scientific review of protocols and results, initiation and consideration of "add-on" studies and analyses, and generation of consensus positions on industry priorities and concerns. Although positioned as an advisory body, ISAB also actively contributes to the ADNI mission of identifying biomarkers of disease progression.
The topics of regional innovation systems (RIS) and cross-border regions attract increasing attention, but few studies combine the themes. Further, the existing empirical studies of cross-border innovation and knowledge creation analyse one case at one point in time, thus, making it difficult...... to assess the progress of integration in the regions, as well as the effect of cross-border innovation policies. Consequently, important questions are left unanswered, including the central research question of this paper: does the sudden removal of significant physical barriers directly impacts...... collaboration activity in cross-border innovation systems? This paper examines regional integration in the Oresund Region over time. It deals with a specific part of the RIS, as it analyses research collaboration between actors from the Danish and Swedish sides, with a specific emphasis on the biotech industry...
Machado, Henrique; Sonnenschein, Eva; Melchiorsen, Jette;
of bioactive compounds leading to successful applications in pharmaceutical and biotech industries. Marine bacteria have so far not been exploited to the same extent; however, they are believed to harbor a multitude of novel bioactive chemistry. To explore this potential, genomes of 21 marine Alpha......- and Gammaproteobacteria collected during the Galathea 3 expedition were sequenced and mined for natural product encoding gene clusters. Results: Independently of genome size, bacteria of all tested genera carried a large number of clusters encoding different potential bioactivities, especially within the Vibrionaceae...... and Pseudoalteromonadaceae families. A very high potential was identified in pigmented pseudoalteromonads with up to 20 clusters in a single strain, mostly NRPSs and NRPS-PKS hybrids. Furthermore, regulatory elements in bioactivity-related pathways including chitin metabolism, quorum sensing and iron scavenging systems were...
Full Text Available Abstract Background Concerns have recently been raised about the negative effects of patents on innovation. In this study, the effects of patents on innovations in the Korean biotech SMEs (small and medium-sized entrepreneurs were examined using survey data and statistical analysis. Results The survey results of this study provided some evidence that restricted access problems have occurred even though their frequency was not high. Statistical analysis revealed that difficulties in accessing patented research tools were not negatively correlated with the level of innovation performance and attitudes toward the patent system. Conclusion On the basis of the results of this investigation in combination with those of previous studies, we concluded that although restricted access problems have occurred, this has not yet deterred innovation in Korea. However, potential problems do exist, and the effects of restricted access should be constantly scrutinized.
Full Text Available The potential rewards are well worth the effort. Estimates in the US put the number of patients on transplant waiting lists at over 75,000. Recent figures from the United Network for Organ Sharing indicate that around 5% of these die while waiting for a transplant organ to become available. Interest and investment levels are high—the US National Institute of Standards and Technology's Advanced Technology Program has poured millions of dollars into tissue engineering product development and the National Institute of Health set up a working group last year. Several biotech companies have sprung up to meet demand, such as Organogenesis and Advanced Tissue Sciences (ATS. Gail Naughton, president of ATS, was named the 2000 National Inventor of the Year for her pioneering work in this field.
Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan
Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceutical companies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceutical companies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma.
Virtual screening (VS) is an efficient hit-finding tool. Its distinctive strength is that it allows one to screen compound libraries that are not available in the lab. Moreover, structure-based (SB) VS also enables an understanding of how the hit compounds bind the protein target, thus laying ground work for the rational hit-to-lead progression. SBVS requires a very limited experimental effort and is particularly well suited for academic labs and small biotech companies that, unlike pharmaceutical companies, do not have physical access to quality small-molecule libraries. Here, we describe SBVS of commercial compound libraries for Mer kinase inhibitors. The screening protocol relies on the docking algorithm Glide complemented by a post-docking filter based on structural protein-ligand interaction fingerprints (SPLIF).
This study examines how radical front end innovation can be actively facilitated through selected and targeted HR practices and bundles of HR practices. The empirical field is an explorative case study of front end innovation and HR practices in the pharmaceutical industry, with an in-depth case...... study of the Danish pharmaceutical company, H. Lundbeck A/S, and explorative studies of seven European and American pharmaceutical and biotech companies. The study aims to show how companies can apply HR practices in ways that actively supports the development of radical front end innovation. The value...... added and the contribution of this article to the existing FEI and HR literature therefore lies in the exploration and mapping of how radical front end innovation is and can be facilitated through targeted HR practices; and in identifying the unique opportunities and challenges of innovation...
Song Biao(宋彪); Chen Xiangsheng(陈祥生); Yin Yueping(尹跃平); Yao Xu(姚煦); Li Wengzhong(李文忠)
Objectives: To compare the efficiency of four commercial ELISA kits in detecting type-specific HSV-2 IgG antibodies. Materials and Methods: A total of 125 subjects, including 105 with genital ulcers, and 20 controls without any history of STDs were recruited from the STD clinic for detection of type-specific HSV-2 IgG antibody with different kits. Four kinds of commercially available ELISA kits, including Quida HSV2 IgG ELISA (Aifulang Biochem Co. Ltd., Hangzhou), TORCH-HSV2 IgG (Jingmei Biotech Co. Ltd., Shanghai), CaptiaTM HSV2 IgG (Trinity biotech, USA ) and HerpeSelect TM 2 ELISA IgG (Focus technologies, USA) were used for evaluation. Western Blot assay was performed as a gold standard.Results: Compared to Western Blot results, the sensitivity and specificity of the kits (Quida HSV2, TORCHHSV2, CaptiaTM HSV2 and HerpeSelectTM 2) were 13.1% and 98.4%, 7.5% and 100%, 100% and 11.1%,87.7 % and 96.7 %, respectively. The positive predictive value (PV) and negative PV of the four kits were 88.9%and 54.3%, 100% and 55.5%, 55.6% and 100%, 96.2%and 89.2%, respectively. The areas under the ROC curve of three kits (Quida HSV2, CaptiaTM HSV2 andHerpeSelectTM 2) were 0.885 (0.822～0.948), 0.825 (0.747- 0.902), 0.974 (0.950 - 0.998), respectively Conclusion: The performance of HerpeSelectTM 2 is the best among the four kits. The results also indicate that the commercially available kits for detection of type-specific HSV2 antibody should be re-evaluated in terms of their validity.
Chromatography process development in the quality by design paradigm I: Establishing a high-throughput process development platform as a tool for estimating "characterization space" for an ion exchange chromatography step.
Bhambure, R; Rathore, A S
This article describes the development of a high-throughput process development (HTPD) platform for developing chromatography steps. An assessment of the platform as a tool for establishing the "characterization space" for an ion exchange chromatography step has been performed by using design of experiments. Case studies involving use of a biotech therapeutic, granulocyte colony-stimulating factor have been used to demonstrate the performance of the platform. We discuss the various challenges that arise when working at such small volumes along with the solutions that we propose to alleviate these challenges to make the HTPD data suitable for empirical modeling. Further, we have also validated the scalability of this platform by comparing the results from the HTPD platform (2 and 6 μL resin volumes) against those obtained at the traditional laboratory scale (resin volume, 0.5 mL). We find that after integration of the proposed correction factors, the HTPD platform is capable of performing the process optimization studies at 170-fold higher productivity. The platform is capable of providing semi-quantitative assessment of the effects of the various input parameters under consideration. We think that platform such as the one presented is an excellent tool for examining the "characterization space" and reducing the extensive experimentation at the traditional lab scale that is otherwise required for establishing the "design space." Thus, this platform will specifically aid in successful implementation of quality by design in biotech process development. This is especially significant in view of the constraints with respect to time and resources that the biopharma industry faces today.
Maghari, Behrokh Mohajer; Ardekani, Ali M
Biotechnology is providing us with a wide range of options for how we can use agricultural and commercial forestry lands. The cultivation of genetically modified (GM) crops on millions of hectares of lands and their injection into our food chain is a huge global genetic experiment involving all living beings. Considering the fast pace of new advances in production of genetically modified crops, consumers, farmers and policymakers worldwide are challenged to reach a consensus on a clear vision for the future of world food supply. The current food biotechnology debate illustrates the serious conflict between two groups: 1) Agri-biotech investors and their affiliated scientists who consider agricultural biotechnology as a solution to food shortage, the scarcity of environmental resources and weeds and pests infestations; and 2) independent scientists, environmentalists, farmers and consumers who warn that genetically modified food introduces new risks to food security, the environment and human health such as loss of biodiversity; the emergence of superweeds and superpests; the increase of antibiotic resistance, food allergies and other unintended effects. This article reviews major viewpoints which are currently debated in the food biotechnology sector in the world. It also lays the ground-work for deep debate on benefits and risks of Biotech-crops for human health, ecosystems and biodiversity. In this context, although some regulations exist, there is a need for continuous vigilance for all countries involved in producing genetically engineered food to follow the international scientific bio-safety testing guidelines containing reliable pre-release experiments and post-release track of transgenic plants to protect public health and avoid future environmental harm.
Guilherme Fowler de Avila Monteiro
Full Text Available This paper examines the governance of property rights on genetically modified (GM soybean seeds. Specifically, the article undertakes a comparative analysis on the collection of royalties in GM soybean seeds in the U.S. and Brazil. For each country, the authors describe the regulatory framework governing the protection of biotechnology innovations in agriculture and investigate the mechanisms of royalty collection in GM soybean seeds. The paper also offers econometric evidence linking the capture of value on biotech innovations and the protection mechanisms deployed by biotech firms. The results suggest that, subject to the institutional environment, firms may choose to transact a GM attribute separated from the seed, building specialized governance structures framed around the genetic attribute and not around the seed as a whole.Este artigo examina a governança de direitos de propriedade em sementes transgênicas de soja. Especificamente, o estudo empreende uma análise comparativa sobre a cobrança de royalties em sementes transgênicas de soja nos EUA e no Brasil. Para cada país, os autores descrevem a estrutura regulatória que rege a proteção de inovações biotecnológicas na agricultura e investigam os mecanismos de cobrança de royalties em sementes transgênicas de soja. O artigo também examina evidências econométricas que relacionam a captura de valor sobre inovações biotecnológicas e os mecanismos de proteção utilizados por firmas de biotecnologia. Os resultados sugerem que, com base no ambiente institucional, uma firma pode optar por transacionar um atributo transgênico separado da semente, estabelecendo estruturas especializadas de governança que se emolduram em torno do atributo e não da semente em si.
戴宝江; 孙青山; 王荣; 吴琳
生物技术及新医药产业是一个基于科技创新的高技术先导产业，21世纪以来已被世界许多国家和国内众多地区竞相列为重点扶持发展的新兴产业。南通作为我国首批对外开放的沿海城市之一，生物技术及新医药产业的发展，与泰州、连云港等兄弟市以及我市船舶制造等行业相比差距较大，要奋起直追，推动该市生物技术及新医药产业的结构转型升级，力争发展成为新兴的支持产业。文章在广泛调研的基础上，分析了南通生物技术及新医药产业发展现状，并提出了相应的对策措施。%Biotechnology and new pharmaceutical industry is a leading high-tech innovation-based industries. Since the beginning of 21st century, this industry has been listed as one of the key emerging industries by many countries and regions. Nantong, one of the first coastal and open-up cities, is lagged behind Taizhou and Lianyungang in terms of biotech and new pharmaceutical industry. There is great gap between this very industry and ship manufacturing industry. To catch up, we need to accelerate the restructuring and upgrading of this industry, making it the emerging supporting industry. This paper analyzes the current situation of biotech and pharmaceutical industry and puts forth relevant countermeasures based on wide researches.
Full Text Available Filtration steps are ubiquitous in biotech processes due to the simplicity of operation, ease of scalability and the myriad of operations that they can be used for. Microfiltration, depth filtration, ultrafiltration and diafiltration are some of the most commonly used biotech unit operations. For clean feed streams, when fouling is minimal, scaling of these unit operations is performed linearly based on the filter area per unit volume of feed stream. However, for cases when considerable fouling occurs, such as the case of harvesting a therapeutic product expressed in Pichia pastoris, linear scaling may not be possible and current industrial practices involve use of 20–30% excess filter area over and above the calculated filter area to account for the uncertainty in scaling. In view of the fact that filters used for harvest are likely to have a very limited lifetime, this oversizing of the filters can add considerable cost of goods for the manufacturer. Modeling offers a way out of this conundrum. In this paper, we examine feasibility of using the various proposed models for filtration of a therapeutic product expressed in Pichia pastoris at constant pressure. It is observed that none of the individual models yield a satisfactory fit of the data, thus indicating that more than one fouling mechanism is at work. Filters with smaller pores were found to undergo fouling via complete pore blocking followed by cake filtration. On the other hand, filters with larger pores were found to undergo fouling via intermediate pore blocking followed by cake filtration. The proposed approach can be used for more accurate sizing of microfilters and depth filters.
Grütter, Markus G
The first protein crystallography group in Switzerland was installed at the Biozentrum of the University of Basel approximately 40 years ago. Since then protein crystallography has grown and matured remarkably and is now established in the molecular biology, biochemistry or biological medicine departments of most major Swiss Universities as well as in the pharmaceutical industry and in biotech startup companies. Swiss X-ray biocrystallography groups have made remarkable contributions from the beginning and have brought Switzerland to the forefront in biostructural research during the last 5 to 10 years. Switzerland has now a leading position in the areas of supramolecular complexes, membrane proteins and structure-based drug design in pharmaceutical and biotech industries. Protein crystallography on the outer membrane protein ompF as well as the development of the lipidic cubic phase crystallization methodology has been pioneered at the Biozentrum. The latter found its somewhat late recognition through the recent explosion in structure determinations of the seven transmembrane helix G-coupled receptors. Highlights from Swiss structural biology groups in the field of supramolecular complexes include the structures of ribosomal particles, of the nucleosome and the pilus assembly complex of uropathogenic E. coli. On the membrane protein side advances in the field of ABC transporters and ion channels are world-recognized achievements of Swiss structural biology. Dedicated laboratories at many academic and industrial institutions, their current research programs, the availability of excellent infrastructure and the continuing efforts to build new facilities such as the SwissFEL indicate an even brighter future for structural biology in Switzerland.
Lauer, I; Bonnewitz, B; Meunier, A; Beverini, M
Proteases are commonly used in the biscuit and cracker industry as processing aids. They cause moderate hydrolysis of gluten proteins and improve dough rheology to better control product texture and crunchiness. Commercial bacterial proteases are derived from Bacillus fermentation broth. As filtration and ultrafiltration are carried out as the only recovery steps, these preparations contain also alpha-amylase and beta-glucanase as the main side activities. The aim of this study is to purify and characterize the Bacillus subtilis metalloprotease from a commercial preparation, in order to study separately the impact of the protease activity with regards to its functionality on biscuit properties. Purification was achieved by means of affinity chromatography on Cibacron Blue and HIC as a polishing step. Affinity appeared to be the most appropriate matrix for large scale purification while ion exchange chromatography was inefficient in terms of recovery yields. The crude product was first loaded on a Hi Trap Blue column (34 microm, Pharmacia Biotech); elution was carried out with a gradient of NaCl in the presence of 1 mM ZnCl2. This step was only efficient in the presence of Zn cations, because this salt promoted both protease stabilization resulting in high recovery yields and also complexation of amylase units into dimers resulting in amylase retention on the column and a better separation of the 3 activities. Beta-glucanase was mostly non retained on the column and a part was coeluted with the protease. This protease fraction was then loaded on a Resource Phe column (15 microm, Pharmacia Biotech) in a last step of polishing. Elution was carried out with a linear gradient of 100-0% ammonium sulfate 1.3 M; protease was eluted at the beginning of the gradient and well separated from amylase and glucanase trace impurities. The homogeneity of the purified protease was confirmed by SDS-PAGE, which showed that its MW was about 38. pH and temperature optima were also
Features of the local immunity state of upper respiratory tract mucosa in children – pupil-orphans of children’s home and effectiveness of seasonal prophylaxis of ARVI using multicomponent herbal preparation
Full Text Available A total of 116 children from children’s homes at the age from 3 to 17 years during clinical well-being were inspected. The question on possibility of immunological examination of organized groups of children and the need of seasonal prophylaxis of ARVI using multicomponent herbal preparation hase been submitted with the city department of health, city department of education, with heads of children's homes as official guardians of children, being in full compliance with the requirements of the biotic committee, considering ICH GCP guidelines and Helsinki Declaration on Bioethics, taking into account the rights of a child. The evaluation of the local immunity system in all children from orphanages during clinical well-being by non-invasive methods was done twice - before and after seasonal prophylaxis of ARVI. Standardized microbiological examination of nose and throat mucosa was used; the content of antimicrobial lactoferrin protein (test system Human Lactoferrin, Hycult ® biotech, NTV, "BioKhimMak», α-defensins 1-3 (test system Human HNP 1-3, Hycult ® biotech, NTV, "BioKhimMak" with asses¬sment of SIgA concentration (test system "Vector - BEST", Russia in secretion of oropharyngeal cavity was determined. The presence of significant changes in the system of local immunity in the upper respiratory tract mucosa in children (101 humans with frequent episodes of ARVI due to α-defensins 1-3 reduction and deficit of secretory immunoglobulin A concentrations in oropharyngeal secretions was shown. In 83.3% of cases this occurred in combination with dysbiosis of throat and nasal mucous membranes, the effect of dysbiosis on the local immunity state was confirmed by a correlation analysis. The efficacy of multicomponent herbal preparation in scheme of seasonal ARVI prevention in children was 88%, being proved by the formation of eubiosis of nose and throat mucous membranes in 78% of cases in combination with a significant increase of lactoferrin
Comparison of two methods for purification of plantaricin ST31, a bacteriocin produced by Lactobacillus plantarum ST31 Comparação de dois métodos de purificação da plantaricina ST31, a bacteriocina produzida por Lactobacillus plantarum ST31
Svetoslav D. Todorov
Full Text Available Two methods of purification of the plantaricin ST31, a bacteriocin produced by Lactobacillus plantarum ST31 are used in this study - the method of ammonium sulfate precipitation, Sep-pack C18 cartridge and reverse-phase HPLC chromatography on C18 Nucleosil column, and the method of direct purification by cation exchange SP Sepharose Fast Flow column Amersham (Pharmacia Biotech. The purity of the products from the two experimental protocols are examined for their molecular weight, aminoacid composition and sequence. Comparison of results show that the plantaricins purified with the two methods are identical. Both methods may be used to purify plantaricin ST31. Comparison of the yield in the purification protocols is 0.8% in the HPLC experimental protocol and 5.9% in the cation-exchange chromatography method.Dois métodos de purificação de plantaricin ST31, uma bacteriocina produzida por Lactobacillus plantarum ST31 foram usados neste estudo - o método de precipitação pelo sulfato de amônia usando cartucho Sep-pack C18 para a filtração e HPLC de fase reversa em coluna de C18 Nucleosil, e o método de purificação direta por troca catiônica SP Sepharose "Fast Flow column Amersham" (Pharmacia Biotech. A pureza dos produtos obtidos pelos dois protocolos foi examinada através da determinação dos pesos moleculares, composição e seqüência dos aminoácidos. A comparação destes resultados revelou que, em termos da pureza dos produtos, não havia diferenças entre os dois métodos de purificação podendo-se, portanto, utilizar qualquer um dos protocolos de purificação testados. No entanto, o rendimento da purificação pelo método da troca catiônica foi de 5.9% enquanto o do método HPLC foi de 0.8%.
Casas, Joseph; Glaser, J. A.; Copenhaver, Ken
Farmers in 25 countries on six continents are using plant biotechnology to solve difficult crop production challenges and conserve the environment. In fact, 13.3 million farmers, which include 90 percent of the farming in developing countries, choose to plant biotech crops. Over the past decade, farmers increased area planted in genetically modified (GM) crops by more than 10 percent each year, thus increasing their farm income by more than 44 billion US dollars (1996-2007), and achieved economic, environmental and social benefits in crops such as soybeans, canola, corn and cotton. To date, total acres of biotech crops harvested exceed more than 2 billion with a proven 13-year history of safe use. Over the next decade, expanded adoption combined with current research on 57 crops in 63 countries will broaden the advantages of genetically modified foods for growers, consumers and the environment. Genetically modified (GM) crops with the ability to produce toxins lethal to specific insect pests are covering a larger percentage of the agricultural landscape every year. The United States department of Agriculture (USDA) estimated that 63 percent of corn and 65 percent of cotton contained these specific genetic traits in 2009. The toxins could protect billions of dollars of loss from insect damage for crops valued at greater than 165 billion US dollars in 2008. The stable and efficient production of these crops has taken on even more importance in recent years with their use, not only as a food source, but now also a source of fuel. It is in the best interest of the United States Environmental Protection Agency (USEPA) to ensure the continued efficacy of toxin producing GM crops as their use reduces pesticides harmful to humans and animals. However, population genetics models have indicated the risk of insect pests developing resistance to these toxins if a high percentage of acreage is grown in these crops. The USEPA is developing methods to monitor the agricultural
There has been growing concern about the phenomenon of science hype, the tendency to exaggerate the value or near-future application of research results. Although this is a problem that touches every area of biomedicine, the topic of genetics seems to be particularly prone to enthusiastic predictions. The world has been told for over two decades-by the media, researchers, politicians, and the biotech industry-that a genome-driven health care revolution is just around the corner. And while the revolution never seems to arrive, the hopeful rhetoric continues. It has been suggested that this unrelenting "genohype" is having a range of adverse social consequences, including misleading the public and hurting the long-term legitimacy of the field. While we need more good data on the nature and magnitude of these possible harms, few would argue with the proposition that sustained science hype is a bad thing. We all benefit from robust science and accurate public representations of biomedical research. But, to date, there has been very little consideration of the degree to which the scholarship on the related ethical, legal, and social issues has been hyped. Are the conclusions from ELSI scholarship also exaggerated?
Park, H. S.; Shah, R.; Shah, C.
From last decades, intensive research in the field of stem cells proliferation had been promoted due to the unique property of stem cells to self-renew themselves into multiples and has potential to replicate into an organ or tissues and so it's highly demanding though challenging. Bioreactor, a mechanical device, works as a womb for stem cell proliferation by providing nutritious environment for the proper growth of stem cells. Various factors affecting stem cells growth are the bioreactor mechanism, feeding of continuous nutrients, healthy environment, etc., but it always remains a challenge for controlling biological parameters. The present paper unveils the design of mechanical device commonly known as bioreactor in tissues engineering and biotech field, use for proliferation of stem cells and imparts the proper growing condition for stem cells. This high functional bioreactor provides automation mixing of cell culture and stem cells. This design operates in conjunction with mechanism of reciprocating motion. Compare to commercial bioreactors, this proposed design is more convenient, easy to operate and less maintenance is required as bioreactor culture bag is made of polyethylene which is single use purpose. Development of this bioengineering system will be beneficial for better growth and expansion of stem cell
Medicine is evolving every day in its operating procedures and the services offered to patients, emphasizing personalized medicine, safety and medical benefits. The individual patient is more than ever the hub of healthcare organization. Medical innovation is thus a public health priority. However it requires an accurate assessment of medical utility and risk-benefit ratios, and in-depth analysis of economic and organizational impacts. Ten years of experience in the Paris Biotech Santé company incubator has identified key actions for effective support of research projects and the success of innovative companies. Strong expertise is needed to prepare development plans, ensure compliance with regulatory requirements and obtain research funding. During its first decade, this incubator has created 87 innovative companies employing 1500 people, raised more than 90 million euros of funding, and reached a cumulative company value of 1200 million euros. Key factors of success have been identified, but an analysis of the causes of failure shows that operational adjustments are mandatory, particularly a strong commitment from medical experts, in order to promote access to new and useful products for patients while at the same time assessing their social impact.
Yamamoto, K; Wang, J; Yamamoto, S; Tobe, H
In murine osteoblastic MC3T3-E1 cells which produced prostaglandin E2 as a bone resorption factor, the cyclooxygenase-2 induction by tumor necrosis factor alpha (TNFalpha) was suppressed by dexamethasone with an IC(50) of 1 nM. Humulon isolated from hop extract for beer brewing was reported previously as an inhibitor of bone resorption [Tobe, H. et al. (1997) Biosci. Biotech. Biochem. 61, 158-159]. We showed that the compound suppressed the TNFalpha-dependent cyclooxygenase-2 induction with an IC(50) of as low as about 30 nM as demonstrated experimentally by catalytic activity assay, Northern blot analysis and promoter analysis. Reporter gene experiments suggested that humulon blocked the cyclooxygenase-2 expression mediated by NFkappaB and NF-IL6, but the intracellular glucocorticoid receptor was not involved. The catalytic activity of cyclooxygenase-2 was inhibited by humulon with an IC(50) of as high as 1.6 microM. These results showed that humulon suppressed cyclooxygenase-2 induction at the step of transcription.
Full Text Available This Research work is focused on the design, development and technological evolution of emerging fields of Nanotechnology and Conducting Polymer Electronics, Bio-Tech based Embedded Sensors and Smart Systems employing System-0n- Chip (SOC Core, as applied to Health Monitoring of Human and Complex Systems in Engineering and Medicine. With the Invention of Thin-Film Technology, it is now possible to fabricate Novel Conducting-Polymer based sensors and devices with built-in-flexible electronics resulting in high throughput devices and systems that are flexible, lighter, bio-compatible and economical also. The flexible and EmbeddedElectronics is a key enabler for a number of platform methodologies such as Designed Thin-Films, Smart Electronics and Sensor Devices. The integration of the Bio-Sensor with embedded electronics data conditioning and processing SOC and Wireless –Communication System may provide vast opportunities for Biological – Sensor Applications, especially for physiological monitoring of Leukocyte-Counts in blood sample or analyte for Leukemia Patients in the Society.
Ma, Haiching; Deacon, Sean; Horiuchi, Kurumi
Background Protein kinases represent one of the most promising groups of drug targets owing to their involvement in such pathological conditions as cancer, inflammatory diseases, neural disorders, and metabolism problems. In the last few years, numerous pharmaceutical and biotech companies have established kinase high-throughput screening (HTS) programs, and the reagent and service industries for kinase assay platforms, kits, and profiling services have begun to thrive. Objective The plethora of different assay formats available today poses a great challenge to scientists who want to select a technology that will be cost efficient, convenient to use, and have low false positive and false negative rates. Methods In the current review, we summarize the most commonly used kinase assay methods in the drug discovery process, present the advantages and disadvantages of each of these methods, and discuss the challenges of discovering kinase inhibitors by using these technologies. Conclusions The decision of selecting the assay formats for HTS or service platform for profiling should take into account not only the final goals of the screens but also the limitation of resources. PMID:19662101
Sylvia R. M. Broeders
Full Text Available Biotech crops are the fastest adopted crop technology in the history of modern agriculture. The commercialisation of GMO is in many countries strictly regulated laying down the need for traceability and labelling. To comply with these legislations, detection methods are needed. To date, GM events have been developed by the introduction of a transgenic insert (i.e., promoter, coding sequence, terminator into the plant genome and real-time PCR is the detection method of choice. However, new types of genetic elements will be used to construct new GMO and new crops will be transformed. Additionally, the presence of unauthorised GMO in food and feed samples might increase in the near future. To enable enforcement laboratories to continue detecting all GM events and to obtain an idea of the possible presence of unauthorised GMO in a food and feed sample, an intensive screening will become necessary. A pragmatic, cost-effective, and time-saving approach is presented here together with an overview of the evolution of the GMO and the upcoming needs.
The World Vaccine Congress Washington 2009 was held in Chantilly, VA USA April 2O -23rd. The Vaccine congress attracted over 400 participants from across the world, including leading vaccine manufacturers, biotechs, governmental agencies, NGOs, research and academic institutes, venture capital and legal firms, contract service and equipment manufacturers. The speakers covered a wide range of topics, including the role of government and regulatory agencies, funding availability, research and development, manufacturing, packaging and post vaccine evaluations. Past vaccine development efforts have historically focused on infectious diseases. With advancements in the field of immunology, molecular biology and vaccinology, the vaccine field has begun moving in new directions. "Taking aim at novel vaccines market" session chaired by Dr. Una Ryan, Chief Executive Officer of Waltham Technologies, was focused on traditional approaches to novel targets (nosocomial infections), novel approaches to traditional targets (flu and rabies), novel approaches to novel targets (Type 1 diabetes, multiple sclerosis and smoking) and vaccines for developing markets (TB, malaria, rabies). The importance of collaborations among academic institutions, industries, and philanthropic foundations for developing markets was also emphasized.
主观变量是影响个体创新行为的重要因素。通过对16省份59家生物医药企业的问卷调查，探讨主动性人格、工作满意度、工作水平和组织任期等变量与员工创新行为的关系。结果发现，主动性人格对员工创新行为具有正向影响，工作满意度对二者关系具有非线性调节作用，工作水平和组织任期也起调节作用。%Subjective variables are important factors of individual innovation behavior .This article empirically examines the relationship between proactive personality and employee innovation through a sample of 59 biotech and pharmaceutical companies from 16 provinces .Results show that proactive personality has a positive effect on employee innovative behav‐ior ,and job satisfaction non‐linearly moderates the relationship ,job level and organizational tenure also act as moderator variables .
Liang, Zheng-Lun; Mao, Qun-Ying; Wang, Yi-Ping; Zhu, Feng-Cai; Li, Jing-Xin; Yao, Xin; Gao, Fan; Wu, Xing; Xu, Miao; Wang, Jun-Zhi
The prevalence of diseases caused by EV71 infection has become a serious public health problem in the Western Pacific region. Due to a lack of effective treatment options, controlling EV71 epidemics has mainly focused on the research and development (R&D) of EV71 vaccines. Thus far, five organizations have completed pre-clinical studies focused on the development of inactivated EV71 whole-virus vaccines, including vaccine strain screening, process optimization, safety and immunogenicity evaluation, and are in different stages of clinical trials. Among these organizations, three companies in Mainland China [Beijing Vigoo Biological Co., Ltd. (Vigoo), Sinovac Biotech Ltd. (Sinovac) and Institute of Medical Biology, Chinese Academy of Medical Science (CAMS)] have recently completed Phase III trials for the vaccines they developed. In addition, the other two vaccines, developed by National Health Research Institutes (NHRI) of Taiwan and Inviragen Pte., Ltd (Inviragen), of Singapore, have also completed Phase I clinical trials. Published clinical trial results indicate that the inactivated EV71 vaccines have good safety and immunogenicity in the target population (infants) and confer a relatively high rate of protection against EV71 infection-related diseases. The results of clinical trials suggest a promising future for the clinical use of EV71 vaccines. Here, we review and highlight the recent progress on the R&D of inactivated EV71 whole-virus vaccines.
Lackovic, Kurt; Lessene, Guillaume; Falk, Hendrik; Leuchowius, Karl-Johan; Baell, Jonathan; Street, Ian
The Walter and Eliza Hall Institute of Medical Research (WEHI) is Australia's longest serving medical research institute. WEHI's High Throughput Screening (HTS) Facility was established in 2003 with $5 million of infrastructure funds invested by WEHI, and the Victorian State Government's Strategic Technology Initiative through Bio21 Australia Ltd. The Facility was Australia's first truly academic HTS facility and was one of only a handful operating in publicly funded institutions worldwide at that time. The objectives were to provide access to enabling HTS technologies, such as assay design, liquid handling automation, compound libraries and expertise to promote translation of basic research in a national setting that has a relatively young biotech sector and does not have a big Pharma research presence. Ten years on and the WEHI HTS Facility has participated in over 92 collaborative projects, generated over 18 million data points, and most importantly, projects that began in the Facility have been commercialized successfully (due to strong ties with Business Development and emphasis on intellectual property management) and now have molecules progressing in clinical trials.
He, Song; He, Haochen; Xu, Wenjian; Huang, Xin; Jiang, Shuai; Li, Fei; He, Fuchu; Bo, Xiaochen
Large-scale efforts for parallel acquisition of multi-omics profiling continue to generate extensive amounts of multi-dimensional biomedical data. Thus, integrated clustering of multiple types of omics data is essential for developing individual-based treatments and precision medicine. However, while rapid progress has been made, methods for integrated clustering are lacking an intuitive web interface that facilitates the biomedical researchers without sufficient programming skills. Here, we present a web tool, named Integrated Clustering of Multi-dimensional biomedical data (ICM), that provides an interface from which to fuse, cluster and visualize multi-dimensional biomedical data and knowledge. With ICM, users can explore the heterogeneity of a disease or a biological process by identifying subgroups of patients. The results obtained can then be interactively modified by using an intuitive user interface. Researchers can also exchange the results from ICM with collaborators via a web link containing a Project ID number that will directly pull up the analysis results being shared. ICM also support incremental clustering that allows users to add new sample data into the data of a previous study to obtain a clustering result. Currently, the ICM web server is available with no login requirement and at no cost at http://biotech.bmi.ac.cn/icm/.
Zheng, Da-sheng; Crickmore, Neil; Cai, Ya-jun; Yan, Jian-ping; Yuan, Zhi-ming
Asticcacaulis excentricus, who lives in upper-layer waters providing food resource to the mosquito larvae and has been proven to be a successful host to produce the mosquitocidal binary toxins or Cry11Aa toxin from Bacilli (Liu et al., 1996, Nat Biotech 14: 343; Armengol, et al. , 2005, Curr Microbiol 51: 430), was developed to express cyt1Aa gene from Bacillus thuringiensis subsp. israelensis (Bti). Two A. excentricus transformants were constructed with the attempt of producing CytlAa alone and alongside with Cry11Aa, repectively. Detection of expressed Cry11Aa and CytlAa proteins by immunoblot in the recombinant A. excentricus clones showed that either cry11Aa or cyt1Aa was expressed well solely but not simultaneously although both restriction analyses of plasmid DNA and DNA sequencing showed that the transformed plasmid was identical to scheme. To investigate the reason why the recombinant A. excentricus harboring both genes and their ribosome binding site (RBS) sequences expressed only Cry11Aa, the total RNA of A. excentricus cells was extracted and revealed three-band pattern in which all RNA molecule weights are not greater than 16S RNA of Escherichia coli by formamide agarose gel electrophoresis, indicating that different RNA systems within these two Gram-negative strains required distinguishingly organised constructs to express multiple foreign genes. It is hypothesized that an extra promoter upstream of RBS sequence is required to express cyt1Aa in the cry11Aa-cyt1Aa tandom plasmid.
Stryjewska, Agnieszka; Kiepura, Katarzyna; Librowski, Tadeusz; Lochyński, Stanisław
Pharmaceutical biotechnology has a long tradition and is rooted in the last century, first exemplified by penicillin and streptomycin as low molecular weight biosynthetic compounds. Today, pharmaceutical biotechnology still has its fundamentals in fermentation and bioprocessing, but the paradigmatic change affected by biotechnology and pharmaceutical sciences has led to an updated definition. The biotechnology revolution redrew the research, development, production and even marketing processes of drugs. Powerful new instruments and biotechnology related scientific disciplines (genomics, proteomics) make it possible to examine and exploit the behavior of proteins and molecules. Recombinant DNA (rDNA) technologies (genetic, protein, and metabolic engineering) allow the production of a wide range of peptides, proteins, and biochemicals from naturally nonproducing cells. This technology, now approximately 25 years old, is becoming one of the most important technologies developed in the 20(th) century. Pharmaceutical products and industrial enzymes were the first biotech products on the world market made by means of rDNA. Despite important advances regarding rDNA applications in mammalian cells, yeasts still represent attractive hosts for the production of heterologous proteins. In this review we describe these processes.
Paul, Matthew J; Thangaraj, Harry; Ma, Julian K-C
The 1980s and 1990s saw a major expansion of biotechnology into new areas of science including genomics and recombinant technologies. This was coupled to the widespread emergence of academics into the commercial sector as they were encouraged to spin out companies or commercialize their intellectual property. There were many opportunities to raise investment, and extraordinary success stories were prominent across many areas of technology. The field of plant biotechnology for manufacturing recombinant pharmaceuticals (molecular pharming) emerged and was developed in this period. Like other biotechnologies, this was an exciting new development which offered some very obvious benefits and commercial advantages. In particularly, plant molecular pharming represented a highly novel and potentially disruptive manufacturing technology for recombinant proteins. Twenty-five years on, a series of interviews with senior members of sixteen of the most prominent companies involved in the field provides insight into the original drivers for commercialization, strategic thinking and planning behind key commercial decisions and an insider view into the major reasons for commercial success or failure. These observations and recurring themes identified across a number of commercial ventures remain relevant today, as new biotech companies continue to spin out of the world of academia.
Templeton, Neil; Smith, Kevin D; McAtee-Pereira, Allison G; Dorai, Haimanti; Betenbaugh, Michael J; Lang, Steven E; Young, Jamey D
Industrial bioprocesses place high demands on the energy metabolism of host cells to meet biosynthetic requirements for maximal protein expression. Identifying metabolic phenotypes that promote high expression is therefore a major goal of the biotech industry. We conducted a series of (13)C flux analysis studies to examine the metabolic response to IgG expression during early stationary phase of CHO cell cultures grown in 3L fed-batch bioreactors. We examined eight clones expressing four different IgGs and compared with three non-expressing host-cell controls. Some clones were genetically manipulated to be apoptosis-resistant by expressing Bcl-2Δ, which correlated with increased IgG production and elevated glucose metabolism. The metabolic phenotypes of the non-expressing, IgG-expressing, and Bcl-2Δ/IgG-expressing clones were fully segregated by hierarchical clustering analysis. Lactate consumption and citric acid cycle fluxes were most strongly associated with specific IgG productivity. These studies indicate that enhanced oxidative metabolism is a characteristic of high-producing CHO cell lines.
Full Text Available Genetically engineered (GE crops, multi-ingredient foods derived from one or more GE ingredients, and GE agricultural inputs are regulated in the United States under a Coordinated Framework that was literally cobbled together in the early 1990s. Via this Framework, responsibility is spread across three federal agencies for the assessment and management of potential risks arising from the planting of GE crops, the raising of GE animals, or uses of GE inputs.The Framework was incomplete and conceptually flawed from the beginning. Despite multiple, piecemeal efforts to update aspects of GE risk assessment and regulatory policy, the Coordinated Framework survives to this day largely unchanged. Its shortcomings are recognized in both the scientific and legal communities, but meaningful reforms thus far remain out of reach, blocked by the intense controversy now surrounding all things biotech.Five generic reforms and another five specific initiatives are described to create a more robust, science-driven GE regulatory infrastructure in the U.S.
Full Text Available Anita Krishnan,1 Rustom Mody,1 Hemant Malhotra21Lupin Limited, Biotech Division, Maharashtra, India; 2Division of Medical Oncology, RK Birla Cancer Center, SMS Medical College Hospital, Jaipur, India Abstract: Biological product development for launch in multiple geographies with varied regulatory expectations would require a planned and focused strategy, involving the selection of the appropriate reference product, defining the extent of process and product characterization and design of nonclinical and clinical studies. The development for established markets like the European Union and the United States, which have precedence in regulatory pathways, may face very different challenges compared to emerging markets, many of which are still in the nascent stages of regulatory guidelines. A clear and concise understanding of the regulatory framework of each region and awareness of the limitations of health care policies, with an added knowledge of the local factors that influence the biosimilar market, would be desirable for a good business strategy. Herein it is attempted to outline the stages of regional guideline implementation in the various global locations and compare the variability in regulatory requirement between them. The factors that could potentially impact biosimilars business in these regions are also outlined. Finally, the prevailing competition between manufacturers of innovative and biosimilar drugs, which could influence the availability of lifesaving off-patent drugs for critical diseases and the advent of more effective, alternate, or next-generation molecules, is also briefly described. Keywords: guidelines, India, comparability, EMA, US FDA, WHO
Full Text Available Various authors have shown the importance of collaborative relationships for inter-organizational performance, the mode of governance or the trajectory of biotechnology companies. Most of these works analyze the exclusive contractual agreements between companies and their main relationships among individuals. We show that this purely economic approach presents a major limitation: the nature of contractual relationships does not explore in detail how players cooperate. We propose to extend the study of these inter-organizational social relations, seen through the resource exchange in inter-individual. An empirical study on the leaders of the biotechnology industry in the area of human health in France has allowed us to map their relationships and resources they exchange them. Our results confirm the existence of a system of exchange dense and multiple. It presents a hierarchical distribution of various types of resources, where the centre is different from the periphery relations denser, more numerous and more reciprocal. However, comparative analysis of different networks reveals that the relationships of the board are highly centralized, while those of friendship following a more even distribution. We suggest that this phenomenon is part of a compensation mechanism to less central actors to maintain inter-organizational relationships. Finally, two standards of the cooperation process, revealed by the relational behaviour of actors, have been discovered. We suggest that they reflect in part the difficult process of adjustment that must cross a science project out of the realm of academic research and develop in a private structure: the biotech company.
Kanno, Nobuko; Kaneko, Makoto; Tanabe, Kumiko; Jyona, Masahiro; Yokota, Hiromitsu; Yatomi, Yutaka
The automated laboratory analyzer COAGTRON-350 (Trinity Biotech) is used for routine and specific coagulation testing for the detection of fibrin formation utilizing either mechanical principles (ball method) or photo-optical principles, chromogenic kinetic enzyme analysis, and immune-turbidimetric detection systems in one benchtop unit. In this study, we demonstrated and established a parameter for the measurement of factor XIII (FXIII) activity using Berichrom FXIII reagent and the COAGTRON-350 analyzer. The usual protocol used for this reagent, based on the handling method, was slightly modified for this device. The analysis showed that fundamental study for the measurement of FXIII activity under our condition setting was favorable in terms of reproducibility, linearity, and correlation with another assays. Since FXIII is the key enzyme that plays important roles in hemostasis by stabilizing fibrin formation, the measurement of FXIII is essential for the diagnosis of bleeding disorders. Therefore, FXIII activity assessment as well as a routine coagulation testing can be conducted simultaneously with one instrument, which is useful in coagulopathy assessment.
Full Text Available The laboratory diagnosis of infections belonging to the ToRCH complex is mainly based of the determination of the immune status to each individual microrganism. In this report, the diagnostic performance of a new automated EIA plates processor system (SeraQuest - GRIFOLS, Pisa, Italy has been compared with other automaed methods: Enzygnost (Dade behring, Marburg, Germany, EIA Well (RADIM, Pomezia, Italy,VIDAS (bioMériuex, Marcy l’etoile, France. In addition, the diagnostic performance of SeraQuest has also been evaluated for the detection of specific immune response to Epstein Barr virus, in comparison with a conventional EIA test (Delta, Pomezia, Italy and with an immunoblotting method (Genelabs - AlfaBiotech, Milan, Italy.The overal evaluation of SeraQuest demonstrated that this test has sensitivity and specificity well comaparable with those of the other methods studied and that could be used as an alternative test in the serological diagnosis of ToRCH and EBV infections.
Victer, Thayssa Neiva da Fonseca; Dos Santos, Cris Stéphany Rodrigues; Báo, Sônia Nair; Sampaio, Thatiane Lima
Vital to patient safety is the accurate assessment and minimization of risk for human immunodeficiency virus (HIV), Hepatitis C (HCV), and Hepatitis B (HBV) virus transmission by deceased donor organ and tissue transplantation. The pathogens are tested by serological kits based on enzyme-linked immunosorbent assay (ELISA), chemiluminescence (CLIA) and eletrochemiluminescence (ECLIA) immunoassays. Organ transplantation is a highly successful life-saving treatment in Brazil, but the Brazilian Health Surveillance Agency currently mandates that all deceased organ donors are screened for HIV, HCV and HBV following living donor policies. In this review, six ELISA (Wama(®), Bio-Rad(®), Biomerieux(®), DiaSorin(®), Acon Biotech(®) and Biokit(®)), three CLIA (Abbott(®), Siemens(®), Diasorin(®)) and one ECLIA (Roche(®)) were utilized for evaluating the effectiveness of those serological tests for deceased donors in Brazil according to manufacturer's guidelines. NAT for HIV, HCV and HBV can assist with detection of pre-seroconversion for those infections, and only Cobas(®) TaqScreen MPX(®) test, the Tigris System(®) Procleix Ultrio Assay(®) and the Bio-Manguinhos(®) HIV/HCV/HBV NAT are commercially available. Between all the tests, only the manufacturer Abbott(®) and Cobas(®) TaqScreen MPX(®) test are currently validated for cadaver samples.
Full Text Available Aim: The goal was to compare the effects of three different sperm preparation media on sperm motility, viability, and DNA integrity of semen samples from normozoospermic men. Methods: A total of 15 normozoospermic males were included in the study. The semen analysis (SA was performed in accordance with the WHO guidelines (2010. After SA, each sample was divided into three aliquots, and swim-up was performed with three different sperm preparation media (Sperm Preparation Media, Origio, Denmark; Ham′s F10, Biochrome, Berlin, Germany; and VitaSperm TM , Innovative Biotech, Iran. Sperm motility, viability, and DNA fragmentation were evaluated at 0, 1, 2, and 24 h after swim-up. Results: There were no significant differences, at any time intervals, in the total sperm motility between the different sperm preparation media. However, the rate of progressive motility was significantly higher in spermatozoa prepared using the media from Origio in comparison with VitaSperm TM (P = 0.03, whereas no significant difference was found against Ham′s F10 medium. No significant differences in sperm viability were seen between the media products. However, 1 h after swim-up, the extent of sperm DNA fragmentation was lower in the medium from Origio versus VitaSperm TM (P = 0.02. Conclusions: The data showed that the quality of medium for preparation of semen samples from normozoospermic men significantly affects the performance of spermatozoa in assisted conception programs.
Collado, Maria Carmen; Santaella, Marina; Mira-Pascual, Laia; Martínez-Arias, Elena; Khodayar-Pardo, Parisá; Ros, Gaspar; Martínez-Costa, Cecilia
Breast milk (BM) is considered as a reference for infant nutrition. The role of bioactive components, such as cytokines, hormones, growth factors (GFs) and fatty acids (FAs) is poorly known, but they might be implicated in immune response development. The aim of this study was to identify the lipid profile and the spectrum of cytokines and neuronal GF in BM samples and analyse the influence of gestational age and lactation time on these components. This study used a longitudinal prospective method for the characterization of cytokines, FAs and GFs global profiles in 120 BM samples from 40 healthy mothers (20 preterm and 20 term) collected as colostrum, transitional and mature milk. The cytokines were analysed by protein array (Ray Bio® Human Cytokine Array G6. Ray Biotech, Inc. Norcross, GA, USA) and the FAs were analysed by gas chromatography. The FA profile was similar between the term and the preterm BM samples. Omega-3-α-linoleic and docosahexaenoic acid (DHA) and omega-6-linoleic acid were the most abundant in the term and preterm samples during lactation. Omega-3 ETA and omega-3 EPA we observed exclusively in the preterm samples. The cytokine profile showed a different trend based on gestational age. A significantly higher expression of neurotrophic factors was found in the mature preterm milk samples as compared to the mature term samples. Our study is the first to identify the influence and interactions of perinatal factors on cytokine, GFs and FAs in human milk.
A rapid growth of investment into clinical research and new drug development has manifested itself by an exponential increase of new products coming onto the worldwide market. The emerging pharmaceutical and biotech markets in Southeast Asia are believed to be extremely promising from a commercial point of view in the next decade. The unique position of the Asian market and the diversity in clinical research initiatives are linked with diverse regulatory requirements for clinical development and registration of new medicines. Some of these differences have an impact on timelines for marketing authorizations in South Korea, China, Thailand, Japan, Singapore, and other countries. One of the approaches to streamlining regulatory strategy in different countries is the initiation of multicountry international clinical trials trying to address requirements and allowing registration in several regional countries simultaneously. Increasing cooperation between South Asian countries in relation to regulatory requirements and clinical development will facilitate the registration of innovative medicines in this rapidly developing region of the world and enable improved cohesiveness between countries in a drug safety framework.
Vladimir E. Panov
Full Text Available Objective: Calprotectin is a calcium binding heterocomplex protein which appear to have regulatory functions in the inflammatory process. Epithelial cells which expressing calprotectin are more resistant to bacterial invasion . In acute phase inflammatory reactions calprotectin is detectable in elevated levels. The aim of the present study is to detect the calprotectin level in saliva in patients with periodontal disease (chronic and aggressive periodontitis and gingivitis and to follow calprotectin level during azithromycin treatment. Methods and materials: In nine healthy patients without systemic disease and malignancy whole unstimulated saliva was investigated. Salivary calprotectin levels were measured by enzyme-linked-immunosorbent using a commercial kit (ELISA Hycult Biotech. Azithromycin treatment was taken as 500 mg (2 x 250 mg tabls. once daily at 10.00 am for 4 consecutive days. Results: At baseline Day levels of calprotectin ranged between 1.45 and 2.97; median 2.19. On Day 5 (first day after azithromycin treatment the salivary calprotectin levels decreased in 6 of the patients. The measured values at Day 10 were more similar to those at Day 5, than those at Day zero. This was confirmed by the values of the average median of calprotectin. Conclusion: We present the first study with the application of antibiotic and measurement the calprotectin levels before, during and after azithromycin intake with no side effects reported. Measuring calprotectin levels could benefit the monitoring of antibiotic treatment efficacy in patients with gingivitis and periodontitis.
Full Text Available Various authors have shown the importance of collaborative relationships for inter-organizational performance, the mode of governance or the trajectory of biotechnology companies. Most of these works analyze the exclusive contractual agreements between companies and their main relationships among individuals. We show that this purely economic approach presents a major limitation: the nature of contractual relationships does not explore in detail how players cooperate. We propose to extend the study of these inter-organizational social relations, seen through the resource exchange in inter-individual. An empirical study on the leaders of the biotechnology industry in the area of human health in France has allowed us to map their relationships and resources they exchange them. Our results confirm the existence of a system of exchange dense and multiple. It presents a hierarchical distribution of various types of resources, where the centre is different from the periphery relations denser, more numerous and more reciprocal. However, comparative analysis of different networks reveals that the relationships of the board are highly centralized, while those of friendship following a more even distribution. We suggest that this phenomenon is part of a compensation mechanism to less central actors to maintain inter-organizational relationships. Finally, two standards of the cooperation process, revealed by the relational behaviour of actors, have been discovered. We suggest that they reflect in part the difficult process of adjustment that must cross a science project out of the realm of academic research and develop in a private structure: the biotech company.
Michael E Stokes
Full Text Available In contrast to the dominant drug paradigm in which compounds were developed to fit all, new models focused around personalized medicine are appearing where treatments are customized for individual patients. The agricultural biotechnology industry should also think about these new personalized models. For example, most common herbicides are generic in action, which led to the development of genetically modified crops to add specificity. The ease and accessibility of modern genomic analysis should facilitate the discovery of chemicals that are more selective in their utility. Is it possible to develop species-selective herbicides and growth regulators? More generally put, is plant research at a stage where chemicals can be developed that streamline plant development and growth to various environments? We believe the advent of chemical genomics now opens up these and other opportunities to personalize agriculture. Furthermore, chemical genomics does not necessarily require genetically tractable plant models, which in principle should allow quick translation to practical applications. For this to happen, however, will require collaboration between the Ag-biotech industry and academic labs for early-stage research and development.
McInerney, John G.
Novalux Inc was an enterprise founded by Aram Mooradian in 1998 to commercialise a novel electrically pumped vertical extended cavity semiconductor laser platform, initially aiming to produce pump lasers for optical fiber telecommunication networks. Following successful major investment in 2000, the company developed a range of single- and multi-mode 980 nm pump lasers emitting from 100-500 mW with excellent beam quality and efficiency. This rapid development required solution of several significant problems in chip and external cavity design, substrate and DBR mirror optimization, thermal engineering and mode selection. Output coupling to single mode fiber was exceptional. Following the collapse of the long haul telecom market in late 2001, a major reorientation of effort was undertaken, initially to develop compact 60-100 mW hybrid monolithically integrated pumplets for metro/local amplified networks, then to frequency-doubled blue light emitters for biotech, reprographics and general scientific applications. During 2001-3 I worked at Novalux on a career break from University College Cork, first as R&D Director managing a small group tasked with producing new capabilities and product options based on the NECSEL platform, including high power, pulsed and frequency doubled versions, then in 2002 as Director of New Product Realization managing the full engineering team, leading the transition to frequency doubled products.
Hønge, Bo Langhoff; Jespersen, S; Medina, C
to detect HBV surface antigen (HBsAg) and anti-HCV among HIV-infected patients in Guinea-Bissau. METHODS: Blood samples from HIV-infected patients in Guinea-Bissau were stored after testing for HBsAg and anti-HCV with rapid tests. Samples were subsequently re-tested for HBsAg and anti-HCV in Denmark....... RESULTS: Two rapid tests were used in Guinea-Bissau: HBsAg Strip Ref 2034 (VEDA.LAB, Alençon, France; sensitivity 62.3%; specificity 99.2%) and HEPA-SCAN (Bhat Bio-Tech, Bangalore, India; sensitivity 57.1%; specificity 99.7%). In the two tests the ability to obtain the correct outcome depended...... on the antigen and antibody concentrations, respectively. Sex, age, CD4 cell count and antiretroviral therapy status did not differ between false negative and true positive samples in either of the tests. The study is limited by a low number of anti-HCV positive samples. CONCLUSIONS: New diagnostic rapid tests...
de Pascale, Donatella; De Santi, Concetta; Fu, Juan; Landfald, Bjarne
The term bioprospecting has been adopted for systematic searches in nature for new bioactive compounds, genes, proteins, microorganisms and other products with potential for commercial use. Much effort has been focused on microorganisms able to thrive under harsh conditions, including the Polar environments. Both the lipid and protein cellular building blocks of Polar microorganisms are shaped by their adaptation to the permanently low temperatures. In addition, strongly differing environments, such as permafrost, glaciers and sea ice, have contributed to additional functional diversity. Emerging massive-parallel sequencing technologies have revealed the existence of a huge, hitherto unseen diversity of low-abundance phylotypes--the rare biosphere--even in the Polar environments. This realization has further strengthened the need to employ cultivation-independent approaches, including metagenomics and single-cell genomic sequencing, to get comprehensive access to the genetic diversity of microbial communities for bioprospecting purposes. In this review, we present an updated snapshot of recent findings on the molecular basis for adaptation to the cold and the phylogenetic diversities of different Polar environments. Novel approaches in bioprospecting are presented and we conclude by showing recent bioprospecting outcomes in terms of new molecules patented or applied by some biotech companies.
Seung-Ah Chung; Michael G. Francom; Kathryn Ting
韩国正在修改其法律和法规，以体现《卡塔赫纳生物安全议定书》中的最新要求以及其他国际惯例。这些修订将让新转基因成分和转基因产品贸易的审批更加可以预测和透明。消费者对转基因食品的态度开始缓和，但是负面观点仍然存在。发动本地农民支持采用和积极推广这种技术在本地种植的作物中的采用被认为是增强消费者信心的关键。%Korea is in the process of revising its laws and regulations to reflect the current language in the Cartagena Protocol on Biosafety as well as other international practices. These revisions will make the approval of new biotech events and the trade in these products more predictable and transparent. Consumer attitudes toward the use of biotechnology in food are starting to soften, but negative perceptions still persist. Generating local farmers' support to adopt and actively use this technology in locally grown crops is seen as the key to increasing consumer confidence.
Silva, Jerson L.; Foguel, Debora; Suarez, Marisa; Gomes, Andre M. O.; Oliveira, Andréa C.
High pressure has emerged as an important tool to tackle several problems in medicine and biotechnology. Misfolded proteins, aggregates and amyloids have been studied, which point toward the understanding of the protein misfolding diseases. High hydrostatic pressure (HHP) has also been used to dissociate non-amyloid aggregates and inclusion bodies. The diverse range of diseases that result from protein misfolding has made this theme an important research focus for pharmaceutical and biotech companies. The use of high pressure promises to contribute to identifying the mechanisms behind these defects and creating therapies against these diseases. High pressure has also been used to study viruses and other infectious agents for the purpose of sterilization and in the development of vaccines. Using pressure, we have detected the presence of a ribonucleoprotein intermediate, where the coat protein is partially unfolded but bound to RNA. These intermediates are potential targets for antiviral compounds. The ability of pressure to inactivate viruses, prions and bacteria has been evaluated with a view toward the applications of vaccine development and virus sterilization. Recent studies demonstrate that pressure causes virus inactivation while preserving the immunogenic properties. There is increasing evidence that a high-pressure cycle traps a virus in the 'fusion intermediate state', not infectious but highly immunogenic.
Chung, I-Fang; Chang, Shing-Jyh; Chen, Chen-Yang; Liu, Shu-Hsuan; Li, Chia-Yang; Chan, Chia-Hao; Shih, Chuan-Chi; Cheng, Wei-Chung
We previously presented the YM500 database, which contains >8000 small RNA sequencing (smRNA-seq) data sets and integrated analysis results for various cancer miRNome studies. In the updated YM500v3 database (http://ngs.ym.edu.tw/ym500/) presented herein, we not only focus on miRNAs but also on other functional small non-coding RNAs (sncRNAs), such as PIWI-interacting RNAs (piRNAs), tRNA-derived fragments (tRFs), small nuclear RNAs (snRNAs) and small nucleolar RNAs (snoRNAs). There is growing knowledge of the role of sncRNAs in gene regulation and tumorigenesis. We have also incorporated >10 000 cancer-related RNA-seq and >3000 more smRNA-seq data sets into the YM500v3 database. Furthermore, there are two main new sections, ‘Survival' and ‘Cancer', in this updated version. The ‘Survival’ section provides the survival analysis results in all cancer types or in a user-defined group of samples for a specific sncRNA. The ‘Cancer’ section provides the results of differential expression analyses, miRNA–gene interactions and cancer miRNA-related pathways. In the ‘Expression’ section, sncRNA expression profiles across cancer and sample types are newly provided. Cancer-related sncRNAs hold potential for both biotech applications and basic research. PMID:27899625
At BASF's Ludwigshafen headquarters, kids and young adults in grades 1-13 can learn about chemistry in the Kids' Labs. Different programs exist for different levels of knowledge. In the two 'Hands-on Lab H(2)O & Co.' Kids' Labs, students from grades 1-6 explore the secrets of chemistry. BASF Kids' Labs have now been set up in over 30 countries. In Switzerland alone, almost 2,000 students have taken part in the 'Water Loves Chemistry' Kids' Lab since it was started in 2011. In Alsace, 600 students have participated to date. In the Teens' Lab 'Xplore Middle School', middle school students explore five different programs with the themes 'substance labyrinth', 'nutrition', 'coffee, caffeine & co.', 'cosmetics' and 'energy'. Biotechnological methods are the focus of the Teens' Lab 'Xplore Biotech' for students taking basic and advanced biology courses. In the 'Xplore High School' Teens' Lab, chemistry teachers present their own experimental lab instruction for students in basic and advanced chemistry courses. The Virtual Lab has been expanding the offerings of the BASF Kids' Labs since 2011. The online lab was developed by the company for the International Year Of Chemistry and gives kids and young adults the opportunity to do interactive experiments outside of the lab.
Keppel Hesselink, Jan M; Schatman, Michael E
EMA401 is an old molecule, synthesized by Parke-Davis in the last century and characterized at that time as an AT2R antagonist. Professor Maree Smith and her group from the University of Queensland (Australia) patented the drug and many related derivatives and other compounds with high affinity for the AT2R for the indication neuropathic pain in 2004, an example of drug repositioning. After some years of university work, the Australian biotech company Spinifex Pharmaceuticals took over further research and development and characterized the S-enantiomer, code name EMA401, and related compounds in a variety of animal models for neuropathic and cancer pain. EMA401 was selected as the lead compound, based on high selectivity for the AT2R and good oral bioavailability (33%). EMA401, however, was only administered once in a chronic neuropathic pain model, and no data have been published in other pain models, or during steady state, although such data were available for the racemate EMA400 and some related compounds (EMA200, EMA400). A pilot phase IIa study demonstrated the efficacy and safety of the drug taken twice daily as two capsules of 50 mg (400 mg/day). In 2015, Novartis took over the clinical development. Two phase IIb studies designed by Spinifex Pharmaceuticals were put on hold, probably because Novartis wanted to improve the clinical design or collect additional preclinical data. Further data are eagerly awaited, especially since EMA401 is first-in-class in neuropathic pain. PMID:28255254
王伟霞; 李福后; 马桂珍; 秦蕾; 孙涛; 谢晓南
毕业论文是本科生实践教学的重要环节,是全面评估学生专业水平的重要指标.为了提高生物技术专业本科生的毕业论文质量,结合多年的教学与管理经验,我们课题组调查分析了毕业论文实践教学中经常存在的问题,同时探讨了这些问题存在的主要原因.结合我校工作实际,提出了毕业论文工作的改进措施.%Thesis is an important content of undergraduate practi-cal teaching, and it is also an important index to evaluate profes-sional level. In order to improve the quality of thesis of biotech-nology undergraduates, the conditions of undergraduate thesis were investigated, and the main reasons of these problems were analyzed in this paper. Combined with practical work, improve-ment measures were proposed for undergraduate thesis.
Mahler, Stephen M; Huang, Edwin P; Chin, David Y; Gray, Peter P
Therapeutic monoclonal antibodies (mAbs) currently dominate the biologics marketplace. Development of a new therapeutic mAb candidate is a complex, multistep process and early stages of development typically begin in an academic research environment. Recently, a number of facilities and initiatives have been launched to aid researchers along this difficult path and facilitate progression of the next mAb blockbuster. Complementing this, there has been a renewed interest from the pharmaceutical industry to reconnect with academia in order to boost dwindling pipelines and encourage innovation. In this review, we examine the steps required to take a therapeutic mAb from discovery through early stage preclinical development and toward becoming a feasible clinical candidate. Discussion of the technologies used for mAb discovery, production in mammalian cells and innovations in single-use bioprocessing is included. We also examine regulatory requirements for product quality and characterization that should be considered at the earliest stages of mAb development. We provide details on the facilities available to help researchers and small-biotech build value into early stage product development, and include examples from within our own facility of how technologies are utilized and an analysis of our client base. PMID:21822050
Silva, Jerson L; Foguel, Debora; Suarez, Marisa; Gomes, Andre M O; Oliveira, Andrea C [Centro Nacional de Ressonancia Magnetica Nuclear, Departamento de Bioquimica Medica, Instituto de Ciencias Biomedicas, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ 21941-590 (Brazil)
High pressure has emerged as an important tool to tackle several problems in medicine and biotechnology. Misfolded proteins, aggregates and amyloids have been studied, which point toward the understanding of the protein misfolding diseases. High hydrostatic pressure (HHP) has also been used to dissociate non-amyloid aggregates and inclusion bodies. The diverse range of diseases that result from protein misfolding has made this theme an important research focus for pharmaceutical and biotech companies. The use of high pressure promises to contribute to identifying the mechanisms behind these defects and creating therapies against these diseases. High pressure has also been used to study viruses and other infectious agents for the purpose of sterilization and in the development of vaccines. Using pressure, we have detected the presence of a ribonucleoprotein intermediate, where the coat protein is partially unfolded but bound to RNA. These intermediates are potential targets for antiviral compounds. The ability of pressure to inactivate viruses, prions and bacteria has been evaluated with a view toward the applications of vaccine development and virus sterilization. Recent studies demonstrate that pressure causes virus inactivation while preserving the immunogenic properties. There is increasing evidence that a high-pressure cycle traps a virus in the 'fusion intermediate state', not infectious but highly immunogenic.
Festel, Gunter W
The possibility to buy standardized external services or even new and innovative methods within drug discovery has increased dramatically during the last decades. Service providers are able to provide timely and efficient solutions to any given problem within preclinical research. The outsourcing behavior depends on the specific company type. Generally, the outsourcing level of emerging pharmaceutical and biotechnology companies is much higher than established companies due to low or missing internal resources. Whereas the "make-or-buy" decisions of large and fully integrated pharmaceutical companies are mainly competency driven, those of mid-size and small pharmaceutical, as well as biotech companies show a specific combination of cost/capacity and competency. The three different cooperation models "price competition", "project selection," and "strategic partnership" were identified. For all types of companies, the cooperation model of "strategic partnership" offers access to high-level expertise while reducing fixed costs and complexity. This was shown using chemical synthesis as an example but is also true for other areas of preclinical research.
Stottmeister, U; Aurich, A; Wilde, H; Andersch, J; Schmidt, S; Sicker, D
Functionalized compounds, which are difficult to produce by classical chemical synthesis, are of special interest as biotechnologically available targets. They represent useful building blocks for subsequent organic syntheses, wherein they can undergo stereoselective or regioselective reactions. "White Biotechnology" (as defined by the European Chemical Industry [ http://www.europabio.org/white_biotech.htm ], as part of a sustainable "Green Chemistry,") supports new applications of chemicals produced via biotechnology. Environmental aspects of this interdisciplinary combination include: Use of renewable feedstock Optimization of biotechnological processes by means of: New "high performance" microorganisms On-line measurement of substrates and products in bioreactors Alternative product isolation, resulting in higher yields, and lower energy demand In this overview we describe biotechnologically produced pyruvic, 2-oxopentaric and 2-oxohexaric acids as promising new building blocks for synthetic chemistry. In the first part, the microbial formation of 2-oxocarboxylic acids (2-OCAs) in general, and optimization of the fermentation steps required to form pyruvic acid, 2-oxoglutaric acid, and 2-oxo-D-gluconic acid are described, highlighting the fundamental advantages in comparison to chemical syntheses. In the second part, a set of chemical formula schemes demonstrate that 2-OCAs are applicable as building blocks in the chemical synthesis of, e.g., hydrophilic triazines, spiro-connected heterocycles, benzotriazines, and pyranoic amino acids. Finally, some perspectives are discussed.
Batlang, Utlwang; Tsurupe, Gorata; Segwagwe, Amogelang; Obopile, Motshwari
In Botswana, approximately 40% of the population live in rural areas and derive most of their livelihood from agriculture by keeping livestock and practising arable farming. Due to the nature of their farming practises livestock and crops are exposed to diseases and environmental stresses. These challenges offer opportunities for application of biotechnology to develop adaptable materials to the country's environment. On the other hand, the perceived risk of genetically modified organisms (GMOs) has dimmed the promise of the technology for its application in agriculture. This calls for a holistic approach to the application of biotechnology to address issues of biosafety of GMOs. We have therefore assessed the potentials, challenges and opportunities to apply biotechnology with specific emphasis on agriculture, taking cognisance of requirement for its research, development and application in research and teaching institutions. In order to achieve this, resource availability, infrastructure, human and laboratory requirements were analyzed. The analysis revealed that the country has the capacity to carry out research in biotechnology in the development and production of genetically modified crops for food and fodder crops. These will include gene discovery, genetic transformation and development of systems to comply with the world regulatory framework on biosafety. In view of the challenges facing the country in agriculture, first generation biotech crops could be released for production. Novel GM products for development may include disease diagnosis kits, animal disease vaccines, and nutrient use efficiency, drought, and pest and disease resistant food and fodder crops.
From its inception, biotechnology has been a uniquely international enterprise. An American and an Englishman working together elucidated the structure of DNA almost 50 years ago; more recently, the Human Genome Project linked researchers around the world, from the Baylor College of Medicine in Houston to the Beijing Human Genome Center. Today our industry's researchers hail from African villages and Manhattan high rises; from Munich and Melbourne; from London, Ontario, and London, England; from Scotland and Nova Scotia--New Scotland; from Calcutta and Calgary. But in the beginning, the infrastructure that supported these efforts--intellectual property, venture capital, streamlined technology transfer--was less widely dispersed and the world's brightest biotech researchers clustered in only half a dozen scientific Meccas. Previous technological revolutions have spread around the world. Following in their footsteps, biotechnology's global diaspora seems inevitable, especially since governments are promoting it. But as our science and business emigrate from early strongholds in the United States, Canada and Europe across oceans and borders and into new cultures, international tensions over biotechnology continue to grow. In just the last few years, controversies have rolled over R&D spending priorities, genetic patents, bioprospecting, transgenic agriculture and drug pricing. My premise today is that our industry needs to formulate its first foreign policy, one which is cognizant of the miserable judgments and mistakes of other industries--and avoids them.
Banes, Albert J
The author started a niche biotech company in 1985 called Flexcell(®) to distribute an enabling technology, mechanobiology devices, to the field. He was the first University of North Carolina faculty member to start a company and stay with it as he pursued his career in academics. That was an unpopular route at that time, but a path he was driven to navigate. Those interests, merged with his training, led to the design and manufacture of mechanobiology devices such as the Flexercell(®) Strain Unit and the BioFlex(®) flexible bottom culture plates to study fundamental responses of cells to strain. Principles in these devices were also incorporated into bioreactors for tissue engineering, which are standard in the marketplace today. In this article, the major roadblocks will be chronicled that were overcome to help build the field of mechanobiology and create a small biotechnology company. Through example, the author's formula for achieving milestones will be discussed including, the DRIVE it takes to get there ["DRIVE": Determination (Confidence), Research and Development (R&D) and Risk-Taking, Innovation (Imagination) and Intellectual Property, achieving Victory, and Enterprise].
Use of PCR-based assays for the detection of the adventitious agent porcine circovirus type 1 (PCV1) in vaccines, and for confirming the identity of cell substrates and viruses used in vaccine production.
Kumar, Deepak; Beach, Nathan M; Meng, Xiang-Jin; Hegde, Nagendra R
Safety and quality are important issues for vaccines. Whereas reversion to virulence poses a safety risk with live attenuated vaccines, the potential for the presence of adventitious agents is also an issue of vaccine quality. The recent detection or porcine circovirus type 1 (PCV1) in human vaccines has further highlighted the importance of quality control in vaccine production. The purpose of this study was to use a novel conventional PCR to detect PCV1, and subsequently screen materials used in the manufacture of vaccines at Bharat Biotech International Limited, India. The genome or gene fragments of PCV1 were not detected in any of the vaccines and materials tested, including the live attenuated rotavirus vaccine candidate ROTAVAC(®). Further, the identity of the cells and the viruses used as starting materials in the manufacture of these vaccines was confirmed by species-specific PCR or virus-specific RT-PCR, and no cross-contamination was detected in any case. The methods can be applied for regular in-house quality control screening of raw materials and seeds/banks, as well as formulated vaccines.
本文主要研究作为奶业的特殊产品--卡士奶的营销策略如何设计.全文共分成三个部分,第一个部分主要分析卡士奶的产品定位.第二个部分主要分析卡士奶市场现状.第三个部分主要分析绿雪生物公司如何有效地设计卡士奶的营销策略.通过本文的介绍让大家了解卡士奶这种特殊的奶业产品及其有针对性的营销策略.%This paper studies how to design marketing strategy of castel milk-the special dairy products. This paper is divided into three parts. The first part analyzes the product positioning of castel milk. The second part analyzes the marketing situation of castel milk. The third part analyzes how green snow biotech company design marketing strategy about castel milk. Through this introduction, we can know castel milk-the special dairy products and the particular marketing strategy.
Bloch, Jean-François; Tardieu-Guigues, Elisabeth
The sea will be a source of economic development in the next years. Today the research works in marine biotechnologies supply new products and processes. The introduction in the laboratories of a new technology, synthesis biology, is going to increase the possibilities of creation of new products. Exploitation of product stemming from marine biodiversity has to be made with regard to various rights among which industrial property law, maritime law and the Convention on BioDiversity. All participants involved in the promotion of research in marine biotechnology must address the fair and equitable sharing of any commercial exploitation. Carrying out work involving synthetic biology has increased the number of unanswered questions about how operators should manage in order to avoid any threat of being sued for infringements of IP rights or for alleged bio-piracy. This paper, by no means exhaustive in the field, analyzes some of the issues raised on the modification to the landscape in marine biotechnology by the advent of synthetic biology. Such issues indicate how important the collaboration between researchers, industrialists, lawyers is for allowing proper use of marine biotech.
Brüning-Richardson, Anke; Akerblom, Lennart; Klingeborn, Berndt; Anderson, John
This paper describes the improvement of a rapid diagnostic test for the detection of rinderpest virus (RPV) at pen-side and the development of a similar test for the detection of another Morbillivirus, peste de petits ruminants virus (PPRV). Using the Svanova Biotech format, prototype chromatographic strip test devices were developed for RPV and PPRV detection. For the RP device, the incorporation of a monoclonal antibody (Mab), which recognises additional RPV strains of RPV lineage 2, enhanced the range of reactivity of the rapid diagnostic test. The device detected antigen in animals infected experimentally with different RPV strains. It also showed detection levels similar to the RP Clearview™ device reported previously. In addition, RPV was also detected under field conditions in Pakistan. A PPRV specific Mab (C77) was used for the development of the PPR test. This Mab recognised a wide range of PPRV isolates and did not show any cross-reactivity with any other virus tested. In animal experiments the device was able to detect viral antigen in eye swabs taken from the animals. The PPRV test should be invaluable for future PPR control eradication programs.
Guan, Yue Hugh; Hewitson, Peter; van den Heuvel, Remco N A M; Zhao, Yan; Siebers, Rick P G; Zhuang, Ying-Ping; Sutherland, Ian
Manufacturing high-value added biotech biopharmaceutical products (e.g. therapeutic proteins) requires quick-to-develop, GMP-compliant, easy-to-scale and cost effective preparatory chromatography technologies. In this work, we describe the construction and testing of a set of 5-mm inner diameter stainless steel toroidal columns for use on commercially available preparatory scale synchronous J-type counter-current chromatography (CCC) machinery. We used a 20.2m long column with an aqueous two-phase system containing 14% (w/w) PEG1000 and 14% (w/w) potassium phosphate at pH 7, and tested a sample loading of 5% column volume and a mobile phase flow rate of 20ml/min. We then satisfactorily demonstrated the potential for a weekly protein separation and preparation throughput of ca. 11g based on a normal weekly routine for separating a pair of model proteins by making five stacked injections on a single portion of stationary phase with no stripping. Compared to our previous 1.6mm bore PTFE toroidal column, the present columns enlarged the nominal column processing throughput by nearly 10. For an ideal model protein injection modality, we observed a scaling up factor of at least 21. The 2 scales of protein separation and purification steps were realized on the same commercial CCC device.
Commichau, Fabian M; Alzinger, Ariane; Sande, Rafael; Bretzel, Werner; Meyer, Frederik M; Chevreux, Bastien; Wyss, Markus; Hohmann, Hans-Peter; Prágai, Zoltán
Vitamin B6 is a designation for the vitamers pyridoxine, pyridoxal, pyridoxamine, and their respective 5'-phosphates. Pyridoxal 5'-phosphate, the biologically most-important vitamer, serves as a cofactor for many enzymes, mainly active in amino acid metabolism. While microorganisms and plants are capable of synthesizing vitamin B6, other organisms have to ingest it. The vitamer pyridoxine, which is used as a dietary supplement for animals and humans is commercially produced by chemical processes. The development of potentially more cost-effective and more sustainable fermentation processes for pyridoxine production is of interest for the biotech industry. We describe the generation and characterization of a Bacillus subtilis pyridoxine production strain overexpressing five genes of a non-native deoxyxylulose 5'-phosphate-dependent vitamin B6 pathway. The genes, derived from Escherichia coli and Sinorhizobium meliloti, were assembled to two expression cassettes and introduced into the B. subtilis chromosome. in vivo complementation assays revealed that the enzymes of this pathway were functionally expressed and active. The resulting strain produced 14mg/l pyridoxine in a small-scale production assay. By optimizing the growth conditions and co-feeding of 4-hydroxy-threonine and deoxyxylulose the productivity was increased to 54mg/l. Although relative protein quantification revealed bottlenecks in the heterologous pathway that remain to be eliminated, the final strain provides a promising basis to further enhance the production of pyridoxine using B. subtilis.
Duran, Metin; Tepe, Nalan; Yurtsever, Deniz; Punzi, Vito L; Bruno, Charles; Mehta, Raj J
The objective of this study was to evaluate the effects of bioaugmenting anaerobic biosolids digestion with a commercial product containing selected strains of bacteria from genera Bacillus, Pseudomonas, and Actinomycetes, along with ancillary organic compounds containing various micronutrients. Specifically, the effects of the bioaugment in terms of volatile solids destruction and generation and fate of odor-causing compounds during anaerobic digestion and during storage of the digested biosolids were studied. Two bench-scale anaerobic digesters receiving primary and secondary clarifier biosolids from various full-scale biological wastewater treatment plants were operated. One of the digesters received the bioaugment developed by Organica Biotech, while the other was operated as control. The bioaugmented digester generated 29% more net CH(4) during the 8 weeks of operation. In addition, the average residual propionic acid concentration in the bioaugmented digester was 54% of that in the control. The monitoring of two organic sulfide compounds, methyl mercaptan (CH(3)SH) and dimethyl sulfide (CH(3)SCH(3)), clearly demonstrated the beneficial effects of the bioaugmentation in terms of odor control. The biosolids digested in the bioaugmented digester generated a negligible amount of CH(3)SH during 10 days of post-digestion storage, while CH(3)SH concentration in the control reached nearly 300 ppm(v) during the same period. Similarly, peak CH(3)SCH(3) generated by stored biosolids from the bioaugmented digester was only 37% of that from the control.
Full Text Available Raising of alpacas as exotic livestock for wool and meat production and as companion animals is growing in importance in the United States, Europe and Australia. Furthermore the alpaca, as well as the rest of the camelids, possesses the peculiarity of producing single-chain antibodies from which nanobodies can be generated. Nanobodies, due to their structural simplicity and reduced size, are very versatile in terms of manipulation and bio-therapeutic exploitation. In fact the biotech companies involved in nanobody production and application continue to grow in number and size. Hence, the development of reagents and tools to assist in the further growth of this new scientific and entrepreneurial reality is becoming a necessity. These are needed mainly to address alpaca disease diagnosis and prophylaxis, and to develop alpaca immunization strategies for nanobody generation. For instance an immortalized alpaca cell line would be extremely valuable. In the present work the first stabilized alpaca cell line from alpaca skin stromal cells (ASSCs was generated and characterized. This cell line was shown to be suitable for replication of viruses bovine herpesvirus-1, bovine viral diarrhea virus and caprine herpesvirus-1 and the endocellular parasite Neospora caninum. Moreover ASSCs were easy to transfect and transduce by several methods. These two latter characteristics are extremely useful when recombinant antigens need to be produced in a host homologous system. This work could be considered as a starting point for the expansion of the biotechnologies linked to alpaca farming and industry.
Rathore, Anurag S; Pathak, Mili; Godara, Avinash
Biotherapeutics have become the focus of the pharmaceutical industry due to their proven effectiveness in managing complex diseases. Downstream processes of these molecules consist of several orthogonal, high resolution unit operations designed so as to be able to separate variants having very similar physicochemical properties. Typical process development involves optimization of the individual unit operations based on Quality by Design principles in order to define the design space within which the process can deliver product that meets the predefined specifications. However, limited efforts are dedicated to understanding the interactions between the unit operations. This paper aims to showcase the importance of understanding these interactions and thereby arrive at operating conditions that are optimal for the overall process. It is demonstrated that these are not necessarily same as those obtained from optimization of the individual unit operations. Purification of Granulocyte Colony Stimulating Factor (G-CSF), a biotherapeutic expressed in E. coli., has been used as a case study. It is evident that the suggested approach results in not only higher yield (91.5 vs. 86.4) but also improved product quality (% RP-HPLC purity of 98.3 vs. 97.5) and process robustness. We think that this paper is very relevant to the present times when the biotech industry is in the midst of implementing Quality by Design towards process development. © 2015 American Institute of Chemical Engineers Biotechnol. Prog., 32:355-362, 2016.
Jordan, Bertrand R; Tsai, Daniel Fu Chang
This paper examines some ethical issues arising from whole-genome association studies for multigenic diseases, focusing on the case of autism. Events occurring following the announcement of a genetic test for autism in France (2005-2009) are described to exemplify the ethical controversies that can arise when genetic testing for autism is applied prematurely and inappropriately promoted by biotech companies. The authors argue that genetic tests assessing one or a few genes involved in highly multigenic disorders can only be useful if: (1) the genetic linkage found in the scientific study must be statistically convincing, reproducible and also applicable to the population to which the individual considered belongs (scientific validity); (2) the relative risk conferred by the 'high-risk' allele should be high enough to be significant to the patient (significant impact); (3) use of the test should lead to some improvement of outcome for the patient, resulting from adapted treatment if available, or at least from adjustment of lifestyle (or life goals) prompted by the new knowledge generated (clinical utility). Decisions concerning genetic testing for autism involve scientific judgement, value judgement and good knowledge of a constantly evolving therapeutic environment. The implementation of genetic tests for highly multigenic diseases thus requires strong mechanisms to ensure that they are used in a fashion that can benefit patients, and these mechanisms must be able to cope with rapid progress in scientific knowledge and therapeutic intervention.
Charoentong, Pornpimol; Angelova, Mihaela; Efremova, Mirjana; Gallasch, Ralf; Hackl, Hubert; Galon, Jerome; Trajanoski, Zlatko
Recent mechanistic insights obtained from preclinical studies and the approval of the first immunotherapies has motivated increasing number of academic investigators and pharmaceutical/biotech companies to further elucidate the role of immunity in tumor pathogenesis and to reconsider the role of immunotherapy. Additionally, technological advances (e.g., next-generation sequencing) are providing unprecedented opportunities to draw a comprehensive picture of the tumor genomics landscape and ultimately enable individualized treatment. However, the increasing complexity of the generated data and the plethora of bioinformatics methods and tools pose considerable challenges to both tumor immunologists and clinical oncologists. In this review, we describe current concepts and future challenges for the management and analysis of data for cancer immunology and immunotherapy. We first highlight publicly available databases with specific focus on cancer immunology including databases for somatic mutations and epitope databases. We then give an overview of the bioinformatics methods for the analysis of next-generation sequencing data (whole-genome and exome sequencing), epitope prediction tools as well as methods for integrative data analysis and network modeling. Mathematical models are powerful tools that can predict and explain important patterns in the genetic and clinical progression of cancer. Therefore, a survey of mathematical models for tumor evolution and tumor-immune cell interaction is included. Finally, we discuss future challenges for individualized immunotherapy and suggest how a combined computational/experimental approaches can lead to new insights into the molecular mechanisms of cancer, improved diagnosis, and prognosis of the disease and pinpoint novel therapeutic targets.
Bartek, Ronald J
The business model for medical therapy development has changed drastically. Large companies that once conducted their own Research and Development (R&D) and funded all the preclinical studies, all phases of clinical development and marketing of the products are increasingly turning to others for more and more of the earlier work in hopes of being able to in-license a de-risked program well downstream, take it through the final phases of clinical development and into the marketplace. This new paradigm has required patient-advocacy foundations, especially in the rare-disease space, to become far more effective in building relationships with all the players along the therapy-development pathway -- academic scientists, government agencies, other foundations with overlapping interests, biotechs, small biopharmaceutical entities and even the larger industry companies. From the perspective of the patient-advocacy community, these increasingly essential public-private partnerships have taken on the nature of what could be called joint-venture philanthropy and involve a broad spectrum of collaborations and financial relationships between foundations and industry partners that are not without concerns about potential conflicts of interest.
It is generally accepted that the development of novel therapies to treat pregnancy-related disorders, such as preeclampsia, is hampered by the paucity of research funding. Hence, it is with great interest to become aware of at least three novel therapeutic approaches for the treatment of this disorder: exploiting either the anticoagulant activity of antithrombin, the free radical scavenging activity of alpha-1-microglobulin, or the regenerative capacity of placenta-derived mesenchymal stem cells. As these projects are being carried out by small biotech enterprises, the question arises of how they are able to fund such undertakings. A novel strategy adopted by two of these companies is that they successfully petitioned US and EU agencies in order that preeclampsia is accepted in the register of rare or orphan diseases. This provides a number of benefits including market exclusivity, assistance with clinical trials, and dedicated funding schemes. Other strategies to supplement meager research funds, especially to test novel approaches, could be crowdfunding, a venture that relies on intimate interaction with advocacy groups. In other words, preeclampsia meets Facebook. Perhaps similar strategies can be adopted to examine novel therapies targeting either the imbalance in pro- or anti-angiogenic growth factors, complement activation, reduced levels of placenta protein 13, or excessive neutrophil activation evident in preeclampsia. PMID:25767802
It is generally accepted that the development of novel therapies to treat pregnancy-related disorders, such as preeclampsia, is hampered by the paucity of research funding. Hence, it is with great interest to become aware of at least three novel therapeutic approaches for the treatment of this disorder: exploiting either the anticoagulant activity of antithrombin, the free radical scavenging activity of alpha-1-microglobulin, or the regenerative capacity of placenta-derived mesenchymal stem cells. As these projects are being carried out by small biotech enterprises, the question arises of how they are able to fund such undertakings. A novel strategy adopted by two of these companies is that they successfully petitioned US and EU agencies in order that preeclampsia is accepted in the register of rare or orphan diseases. This provides a number of benefits including market exclusivity, assistance with clinical trials, and dedicated funding schemes. Other strategies to supplement meager research funds, especially to test novel approaches, could be crowdfunding, a venture that relies on intimate interaction with advocacy groups. In other words, preeclampsia meets Facebook. Perhaps similar strategies can be adopted to examine novel therapies targeting either the imbalance in pro- or anti-angiogenic growth factors, complement activation, reduced levels of placenta protein 13, or excessive neutrophil activation evident in preeclampsia.
Basel is known for its successful global players in Pharma, Agro and Chemicals. The wealth of top-tier companies, universities and academic institutions in such a small region is unparalleled. It creates an optimum climate for world-class research and its translation into successful businesses. This is also reflected in a strong start-up scene. Over the past decades the multinational players have shown that they are able to adapt to the ever-increasing challenges in the market. Basel has seen blue-chip company mergers, accompanied by the transfer of business assets into spin-off companies. This process created a mind-set for change which has positively influenced the local start-up environment. Actelion is one of these former spin-offs that successfully made the transition to become a global player. BioVersys and PIQUR are two of the most promising very early stage Swiss biotech companies. Many other examples can be found in Northwestern Switzerland. The region also offers a solid background of supporting activities. Infrastructure, coaching and all other support are offered and complement national innovation initiatives.
Liang, Chanjuan; van Dijk, Jeroen P; Scholtens, Ingrid M J; Staats, Martijn; Prins, Theo W; Voorhuijzen, Marleen M; da Silva, Andrea M; Arisi, Ana Carolina Maisonnave; den Dunnen, Johan T; Kok, Esther J
The growing number of biotech crops with novel genetic elements increasingly complicates the detection of genetically modified organisms (GMOs) in food and feed samples using conventional screening methods. Unauthorized GMOs (UGMOs) in food and feed are currently identified through combining GMO element screening with sequencing the DNA flanking these elements. In this study, a specific and sensitive qPCR assay was developed for vip3A element detection based on the vip3Aa20 coding sequences of the recently marketed MIR162 maize and COT102 cotton. Furthermore, SiteFinding-PCR in combination with Sanger, Illumina or Pacific BioSciences (PacBio) sequencing was performed targeting the flanking DNA of the vip3Aa20 element in MIR162. De novo assembly and Basic Local Alignment Search Tool searches were used to mimic UGMO identification. PacBio data resulted in relatively long contigs in the upstream (1,326 nucleotides (nt); 95 % identity) and downstream (1,135 nt; 92 % identity) regions, whereas Illumina data resulted in two smaller contigs of 858 and 1,038 nt with higher sequence identity (>99 % identity). Both approaches outperformed Sanger sequencing, underlining the potential for next-generation sequencing in UGMO identification.
Sartipy, Peter; Björquist, Petter
Using human pluripotent stem cells as a source to generate differentiated progenies for regenerative medicine applications has attracted substantial interest during recent years. Having the capability to produce large quantities of human cells that can replace damaged tissue due to disease or injury opens novel avenues for relieving symptoms and also potentially offers cures for many severe human diseases. Although tremendous advancements have been made, there is still much research and development left before human pluripotent stem cell derived products can be made available for cell therapy applications. In order to speed up the development processes, we argue strongly in favor of cross-disciplinary collaborative efforts which have many advantages, especially in a relatively new field such as regenerative medicine based on human pluripotent stem cells. In this review, we aim to illustrate how some of the hurdles for bringing human pluripotent stem cell derivatives from bench-to-bed can be effectively addressed through the establishment of collaborative programs involving academic institutions, biotech industries, and pharmaceutical companies. By taking advantage of the strengths from each organization, innovation and productivity can be maximized from a resource perspective and thus, the chances of successfully bringing novel regenerative medicine treatment options to patients increase.
This essay analyzes how academic institutions, government agencies, and the nascent biotech industry contested the legal ownership of recombinant DNA technology in the name of the public interest. It reconstructs the way a small but influential group of government officials and university research administrators introduced a new framework for the commercialization of academic research in the context of a national debate over scientific research's contributions to American economic prosperity and public health. They claimed that private ownership of inventions arising from public support would provide a powerful means to liberate biomedical discoveries for public benefit. This articulation of the causal link between private ownership and the public interest, it is argued, justified a new set of expectations about the use of research results arising from government or public support, in which commercialization became a new public obligation for academic researchers. By highlighting the broader economic and legal shifts that prompted the reconfiguration of the ownership of public knowledge in late twentieth-century American capitalism, the essay examines the threads of policy-informed legal ideas that came together to affirm private ownership of biomedical knowledge as germane to the public interest in the coming of age of biotechnology and genetic medicine.
作者阐述了自己对未来流体动力技术的展望与期盼.未来的流体动力技术将会具有更加智能灵活和网络化的特点;能更好地满足可持续发展的要求;能构建巨型或者纳米级的流体动力系统;能在极端环境下工作;作为清洁的绿色技术,通过与纳米技术及生物技术的结合能够为大多数人服务.未来的工作环境将具有多种文化背景,因而要求未来流体动力工程领域的工程技术人员必须具备多学科领域的知识和技能.%Author illustrated a forecasting on the Fluid Power Technology in the future. It will be more smart and networking, more adapting to sustainable, constructed in huge or nano-scales and working for extreme conditions, as clean and green technology, merged with nano-and bio-tech, and service for most peoples. That requests future engineers have multi-discipline knowledge, skills and working in multi-culture background in the world.