The evolution of the biotechnology industry in Germany

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.     

国外动物生物技术研究和产业化趋势分析

生物技术在全世界范围取得了飞速的进展,与此同时其应用和产业化在各国政府、科研机构和生物技术公司的大力参与和激烈竞争中也逐步加快,预计它将成为许多国家经济的重要支柱产业之一。一些重大生物研究项目如人类基因组计划、克隆技术等开始引起公众的广泛注意。综述了２０世纪９０ 来动物生物技术的发展状况,对基因组研究、转基因动物、克隆技术和细胞培养等重要研究方向作了介绍和分析。     

Future prospectives on animal biotechnology

Abstract

Farm animal reproduction is entering the era of embryo engineering ‐ a part of the new biotechnology revolution that has been sweeping the nation during the early 1980s. This comes at a time when the $70 billion livestock industry is hard‐pressed for survival. Not since the commercial development of artificial insemination (AI) techniques in the 1950s has any new technical research development caused such a stir in the livestock community. The genetic impact of artificial insemination (AI) in the cattle industry these last 40 years cannot be questioned. Nearly three‐fourths of the dairy cattle in the United States are now being artificially inseminated. Also, commercial processing of bull semen has been and still is a major agribusiness success story, grossing millions of dollars annually. With the development of embryo transfer (ET) technology in the mid‐1970s, animal reproduction again entered a new age of technical advancement. It appears that AI and embryo methodology are just the beginning of a new age in animal reproduction technology. Recent developments in molecular biology and genetic engineering now offer a new dimension in research and development for future application to seed stock farm animals. New molecular technologies will most certainly change the traditional approach to animal breeding, thus allowing the livestock producer to select breeding stock on genotype rather than phenotype. In the future, researchers will be able to study whole animal biology to a depth never before dreamed using molecular biology.     

Patentable invention in biotechnology

Biotechnology is a rapidly advancing field of technology which offers many benefits to society. It is perceived that an important part of maintaining the momentum, and stimulating further advances, is to protect inventions in biotechnology, where appropriate, with a patent. Here, from the perspective of invention in biotechnology, we examine in brief, the critical elements of proper subject-matter, novelty, utility, non-obviousness and sufficiency of disclosure, as requirements of patentable invention for both the United States and Canada. Topical issues which have arisen in respect of these elements are also canvassed briefly. As will be seen, Canadian Patent Law, while still unresolved with respect to the patenting of higher life forms, is in other respects in step with the pro-patent model of the United States.     

Biotechnology and sustainability: the role of transatlantic cooperation in research and innovation

Life sciences and biotechnology are increasingly providing sustainable solutions in a wide range of areas from medicine to industry, agriculture and the environment. The United States and Europe are the two largest regions in which the revolution in life sciences and biotechnology has been taking place. Established in 1990, the EC-US Task Force on Biotechnology Research has provided a fruitful forum for the exchange of information, for the discussion of ideas and for the joint sponsoring of research activities between the US and the European Union.     

An intellectual property sharing initiative in agricultural biotechnology: development of broadly accessible technologies for plant transformation

The Public Intellectual Property Resource for Agriculture (PIPRA) was founded in 2004 by the Rockefeller Foundation in response to concerns that public investments in agricultural biotechnology benefiting developing countries were facing delays, high transaction costs and lack of access to important technologies due to intellectual property right (IPR) issues. From its inception, PIPRA has worked broadly to support a wide range of research in the public sector, in specialty and minor acreage crops as well as crops important to food security in developing countries. In this paper, we review PIPRA's work, discussing the failures, successes, and lessons learned during its years of operation. To address public sector's limited freedom-to-operate, or legal access to third-party rights, in the area of plant transformation, we describe PIPRA's patent 'pool' approach to develop open-access technologies for plant transformation which consolidate patent and tangible property rights in marker-free vector systems. The plant transformation system has been licensed and deployed for both commercial and humanitarian applications in the United States (US) and Africa, respectively.     

Exploitation of biotechnology in a large company

Almost from the outset, most large companies saw the 'new biotechnology' not as a new business but as a set of very powerful techniques that, in time, would radically improve the understanding of biological systems. This new knowledge was generally seen by them as enhancing the process of invention and not as a substitute for tried and tested ways of meeting clearly identified targets. As the knowledge base grows, so the big-company response to biotechnology becomes more positive. Within ICI, biotechnology is now integrated into five bio-businesses (Pharmaceuticals, Agrochemicals, Seeds, Diagnostics and Biological Products). Within the Central Toxicology Laboratory it also contributes to the understanding of the mechanisms of toxic action of chemicals as part of assessing risk. ICI has entered two of these businesses (Seeds and Diagnostics) because it sees biotechnology making a major contribution to the profitability of each.     

Fungal biotechnology

Fungi are used in many industrial processes, such as the production of enzymes, vitamins, polysaccharides, polyhydric alcohols, pigments, lipids, and glycolipids. Some of these products are produced commercially while others are potentially valuable in biotechnology. Fungal secondary metabolites are extremely important to our health and nutrition and have tremendous economic impact. In addition to the multiple reaction sequences of fermentations, fungi are extremely useful in carrying out biotransformation processes. These are becoming essential to the fine-chemical industry in the production of single-isomer intermediates. Recombinant DNA technology, which includes yeasts and other fungi as hosts, has markedly increased markets for microbial enzymes. Molecular manipulations have been added to mutational techniques as a means of increasing titers and yields of microbial processes and in the discovery of new drugs. Today, fungal biology is a major participant in global industry. Moreover, the best is yet to come as genomes of additional species are sequenced at some level (cDNA, complete genomes, expressed sequence tags) and gene and protein arrays become available.     

Search and discovery strategies for biotechnology: the paradigm shift.

Profound changes are occurring in the strategies that biotechnology-based industries are deploying in the search for exploitable biology and to discover new products and develop new or improved processes. The advances that have been made in the past decade in areas such as combinatorial chemistry, combinatorial biosynthesis, metabolic pathway engineering, gene shuffling, and directed evolution of proteins have caused some companies to consider withdrawing from natural product screening. In this review we examine the paradigm shift from traditional biology to bioinformatics that is revolutionizing exploitable biology. We conclude that the reinvigorated means of detecting novel organisms, novel chemical structures, and novel biocatalytic activities will ensure that natural products will continue to be a primary resource for biotechnology. The paradigm shift has been driven by a convergence of complementary technologies, exemplified by DNA sequencing and amplification, genome sequencing and annotation, proteome analysis, and phenotypic inventorying, resulting in the establishment of huge databases that can be mined in order to generate useful knowledge such as the identity and characterization of organisms and the identity of biotechnology targets. Concurrently there have been major advances in understanding the extent of microbial diversity, how uncultured organisms might be grown, and how expression of the metabolic potential of microorganisms can be maximized. The integration of information from complementary databases presents a significant challenge. Such integration should facilitate answers to complex questions involving sequence, biochemical, physiological, taxonomic, and ecological information of the sort posed in exploitable biology. The paradigm shift which we discuss is not absolute in the sense that it will replace established microbiology; rather, it reinforces our view that innovative microbiology is essential for releasing the potential of microbial diversity for biotechnology penetration throughout industry. Various of these issues are considered with reference to deep-sea microbiology and biotechnology.     

Development of new cell lines for animal cell biotechnology

Mammalian cell culture has been an important technique in laboratory-scale experimentation for many decades. Developments in large-scale culture have been due to the need to grow large numbers of cells to support the growth of viruses for vaccine production, and more recently, for growing hybridoma cells as a source of monoclonal antibody. Increasingly, however, pharmaceutical products such as hormones, enzymes, growth factors, and clotting factors are being produced from cell lines which have been manipulated by recombinant DNA techniques. It is clear, therefore, that the high cost of growing mammalian cells on a large scale does not necessarily prohibit their use for biotechnology, and indeed there is considerable evidence to suggest that animal cell biotechnology will continue to be a major growth area in the future.     

Insect cell culture and biotechnology

The continued development of new cell culture technology is essential for the future growth and application of insect cell and baculovirus biotechnology. The use of cell lines for academic research and for commercial applications is currently dominated by two cell lines; the Spodoptera frugiperda line, SF21 (and its clonal isolate, SF9), and the Trichoplusia ni line, BTI 5B1-4, commercially known as High Five cells. The long perceived prediction that the immense potential application of the baculovirus-insect cell system, as a tool in cell and molecular biology, agriculture, and animal health, has been achieved. The versatility and recent applications of this popular expression system has been demonstrated by both academia and industry and it is clear that this cell-based system has been widely accepted for biotechnological applications. Numerous small to midsize startup biotechnology companies in North America and the Europe are currently using the baculovirus-insect cell technology to produce custom recombinant proteins for research and commercial applications. The recent breakthroughs using the baculovirus-insect cell-based system for the development of several commercial products that will impact animal and human health will further enhance interest in this technology by pharma. Clearly, future progress in novel cell and engineering advances will lead to fundamental scientific discoveries and serve to enhance the utility and applications of this baculovirus-insect cell system.      

Economic issues for the UK biotechnology sector

This paper examines the economic prospects for the biotechnology industry, focusing on the UK position. I discuss some economic issues relating to the structure of the biotechnology industry and examine whether these factors can account for the relative success of the biotechnology sector in the UK compared to other European countries. I emphasize the importance of the science base, pharmaceutical companies and capital markets in giving the UK an advantage. Looking ahead I argue that prospects are good for the global growth of the industry due to supply and demand side factors. The UK is in a leading position in Europe but faces significant dangers, especially from the public towards biotechnology.     

Indian entrepreneurship in biotechnology comes of age

Biotechnology is one of the fastest growing, knowledge-driven industries in India and is expected to play a key role in shaping India’s rapidly developing economy. Since its inception in 1986 the Department of Biotechnology (DBT) has been guiding to foster growth of Indian biotechnology with a range of initiatives. Indian biotechnology industry registered over 3.0 billion USD revenue generation in 2009–10, which constitutes about 2 % share of the global biotechnology market. More than 300 companies are engaged in different biotechnology sectors in India, majority of which are clustered in western and southern regions. Biopharmaceuticals is the largest biotechnology sector in India with about 62 % market share. Bioservices ranked second due to the upward trend in a range of service oriented research activities. Bioagriculture recorded highest growth in 2009–10 and is dominated by insect resistant transgenic cotton. Bioindustrial, which deals with production of enzymes for different industrial uses, is the smallest biotechnology sector in India with 6 % revenue share.     

美国创新创业生态系统中生物技术孵化器的作用

生物医药产业是各大经济体在21世纪优先发展的战略性产业,并逐步成为世界经济的主导产业。我国制定了一系列鼓励政策加快推动生物医药创新发展,为我国生物医药创新打造了良好的大环境。在大众创业、万众创新的大背景下,各地相应建设生物技术科技园和孵化器,促进生物技术企业创新。通过阐述生物产业最为发达的国家——美国不同类型的生物技术孵化器的建设、运营、孵化成功案例等,分析了孵化器内部运营与外部协作的生态关系,总结了孵化器孵化成功的经验,针对我国生物技术孵化器的建立和运营提出了建议。     

Rational and "irrational" design of proteins and their use in biotechnology

A familiar refrain within industrial circles is better, faster, and cheaper. Efforts to place this mantra into practice within the biotechnology industry has brought a focus on protein engineering as one method to create new products quickly and inexpensively. Typically, protein engineering has utilized either rational design or combinatorial methods, both of which have been explored and improved in recent years. Continued advancement in these two areas and their application to an increasing list of industrially and medically important processes mean that the number of "synthetic" proteins displacing old technologies is likely to grow at an amazing rate over the next few years. We discuss some of the technologies available for protein redesign and illustrate these with examples from the biocatalysis, biosensor, and therapeutic fields.     

Commercialization of animal biotechnology

Commercialization of animal biotechnology is a wide-ranging topic for discussion. In this paper, we will attempt to review embryo transfer (ET) and related technologies that relate to food-producing mammals. A brief review of the history of advances in biotechnology will provide a glimpse to present and future applications. Commercialization of animal biotechnology is presently taking two pathways. The first application involves the use of animals for biomedical purposes. Very few companies have developed all of the core competencies and intellectual properties to complete the bridge from lab bench to product. The second pathway of application is for the production of animals used for food. Artificial insemination (AI), embryo transfer, in vitro fertilization (IVF), cloning, transgenics, and genomics all are components of the toolbox for present and future applications. Individually, these are powerful tools capable of providing significant improvements in productivity. Combinations of these technologies coupled with information systems and data analysis, will provide even more significant change in the next decade. Any strategies for the commercial application of animal biotechnology must include a careful review of regulatory and social concerns. Careful review of industry infrastructure is also important. Our colleagues in plant biotechnology have helped highlight some of these pitfalls and provide us with a retrospective review. In summary, today we have core competencies that provide a wealth of opportunities for the members of this society, commercial companies, producers, and the general population. Successful commercialization will benefit all of the above stakeholders.     

现代生物技术与饲用微生态制剂

近年来,使用抗生素的副作用越来越多地受到关注,世界上许多国家已出台相应政策来控制抗生素的使用。但是由于养殖行业的迅猛发展,养殖密度加大,养殖动物病害发病的风险提高,急需可替代抗生素的新型绿色饲料添加剂产品。微生态制剂作为一种新型绿色饲料添加剂,在养殖行业发挥了重要作用。随着饲用微生态制剂产品研发的深入,现代生物技术在提升微生态制剂的理论和应用研究方面发挥着重要作用。PCR、核酸分子杂交、基因工程以及组学等技术已应用于微生物菌种鉴定、基因改良、作用机理等研究中。本文对饲用微生态制剂的研发现状进行了阐述,并综述了现代生物技术在饲用微生态制剂研究中的应用。     

Regulation of animal biotechnology: research needs

Livestock that result from biotechnology have been a part of agricultural science for over 30 years but have not entered the market place as food or fiber. Two biotechnologies are at the forefront as challenges to the world's systems for regulating the market place: animal clones and transgenic animals. Both technologies have come before the Food and Drug Administration in the United States and it appears that action is imminent for clones. The FDA has asserted principles for evaluation of clones and asserts that "... remaining hazard(s) from cloning are likely to be subtle in nature." The science-based principles recognize that in some areas related to developmental biology and gene expression in clones, additional scientific information would be useful. The role of science then is to use the genomic tools that we have available to answer questions about epigenetic regulation of development and reprogramming of genes to the state found in germ cells. Transgenics pose additional challenges to regulators. If the transgenics are produced using cloning from modified cells then the additional scientific information needed will be related to the effects of insertion and expression of the transgenes. Other approaches such as retrovirally vectored transgenesis will elicit additional questions. These questions will be challenging because the science will have to be related to the expression and function of each gene or class of genes. For the promises of animal biotechnology to be fulfilled, scientists will have to resolve many questions for regulators and the public but tools to answer those questions are rapidly becoming available.     

Globalization of biotechnology: The agglomeration of dispersed knowledge and information and its implications for the political economy of technology in developing countries

This study examines a contradictory development in the era of globalization wherein country-specific economic and socio-political institutional environment limits the global flow of technological knowledge and information, particularly in the biotechnology sector. International collaborations for developing new biotechnologies has increased significantly in recent years, but these have virtually bypassed firms in developing countries. The international flow of technologies tends to agglomerate in developed economies particularly in the US, where an appropriate mix of economic choices, social regulation and state action fostered institutional environments that facilitated the development and commercialization of biotechnologies. Moreover, with the heightening competition in the global economy, state and firms of developed economies have evolved into a relationship of close partnership. This shows that, far from being irrelevant, the state remains a political entity that structures the innovation system in order to promote the well-being of its firms. This calls for a re-thinking of the role of the state in technological and economic development, particularly among the developing economies.