国外生物技术产业发展政策研究

全球生物技术产业尚处于发展时期,政府的政策对技术的进步和产业的发展有明显的导向和促进作用。对美国、欧洲等国家和地区的产业政策进行综合研究,发现这些生物技术产业相对发达的国家和地区,尤其是美国,其产业政策已成体系,而且可操作性强,对产业的推动作用明显,具有相当的可借鉴意义。从组织管理结构、科研投入机制、鼓励研发创新、财税支持方式、资本市场培育、产业基地建设、中介服务网络构建、人才培养与引进、以及国际合作等方面对国际上行之有效的生物技术产业政策进行了归纳分析 。     

白色生物技术及其应用进展

“白色”生物技术也叫做工业生物技术,是利用某些微生物或酶进行物质转化,生产新产品或改进原有工业处理过程的技术。其产品可生物降解,生产过程能耗低,废弃物少。它是一门涉及生物学、微生物学、分子生物学、化学以及工程学等多学科的研究领域。综述了白色生物技术的产业优势及其涉及的研究领域,并从生物催化、生物材料、生物能源等方面概述了白色生物技术的应用进展。     

Biotechnology,people and markets

In assessing the likely demand for biotechnology products it is not sufficient just to look at what is happening in firms and their immediate market environment. There is no one 'market' for biotechnology products: there are differences between sectors and between countries. You have instead to look at the institutional contexts of the biotechnology product's development. This paper reviews work which has been carried out by social scientists, especially those using 'social shaping' approaches, on the development of new products based on advances in biotechnology and on the creation of markets to go with these products. It examines work on public attitudes to the exploitation of the technology, focusing especially on the issue of social inclusion and exclusion and how biotechnology might make exclusion more likely. It concludes by considering what current differences in public attitudes to the development of some biotechnology-based products might mean for the development of markets for those products in the UK.     

Maßgeschneiderte Mikroorganismen

Tailor‐made microorganisms Microbial diversity provides unlimited resources for the development of novel industrial processes and products. Since the beginning of the 20th century microorganisms have been successfully applied for the large scale production of bio‐based products. In recent years, modern methods of strain development and Synthetic Biology have enabled biotech engineers to design even more sophisticated and tailor‐made microorganisms. These microbes serve industrial processes for the production of bulk chemicals, enzymes, polymers, biofuels as well as plant‐derived ingredients such as Artemisinin in an ecologically and economically sustainable and attractive fashion. In the future, production of advanced biofuels, microbial fuel cells, CO₂ as feedstock and microbial cellulose are research topics as well as challenges of global importance. Continuous efforts in microbiology and biotechnology research will be pivotal for white biotechnology to gain more momentum in transforming the chemical industry towards a knowledge based bio‐economy.     

Conserving the African rhinoceros

The Southern African rhinoceros population has been dwindling through the years. A lot of effort has been put toward coming up with the most effective way of protecting the black and white rhinoceros population in the world yet still the animals remain endangered despite the enormous global efforts to protect the species. Such conservation efforts include; establishment of sanctuaries, wildlife farming, dehorning, trade and market controls, listing of species as endangered, use of biotechnology and biotelemetry. However useful, each of these methods has its own strengths and weaknesses relative to the success of rhinoceros conservation. It however has been noted in this review that dehorning is the most effective method as it involves removal of the horn hence extinguishing the need for poaching. Despite the high success rate it has also been noted that this requires a great deal of skill and finance hence limiting the application of this technique in developing nations. Sanctuaries provide an ideal breeding environment that is better than the wild and enhanced breeding accounted for a significant increase in rhinoceros population where it has been applied. It was however been conclude that a holistic conservation approach is required to conserve the African rhinoceros.     

Plant molecular farming: systems and products

Plant molecular farming is a new and promising industry involving plant biotechnology. In this review, we describe several diverse plant systems that have been developed to produce commercially useful proteins for pharmaceutical and industrial uses. The advantages and disadvantages of each system are discussed. The first plant-derived molecular farming products have reached the marketplace and other products are poised to join them during the next few years. We explain the rationale for using plants as biofactories. We also describe the products currently on the market, and those that appear likely to join them in the near future. Lastly, we discuss the issue of public acceptance of molecular farming products.Communicated by P.P. Kumar     

Biopharmaceuticals in China

The biopharmaceutical industry, whose products are produced mainly by recombinant DNA technology, antibody technologies and cytotechnology, is the most important sector in industrial biotechnology, and is one of the most rapidly growing high-tech industries. The global market for biopharmaceuticals had been growing at annual growth rates of 15-33% over the last 8 years, and sales exceeded 55 billion dollars in 2005. This review presents an overview of the Chinese biopharmaceutical industry, listing the global top-selling biopharmaceuticals in 2005, and briefly describes the major biotech drugs approved by the Chinese State Food and Drug Administration, such as recombinant cytokines, therapeutic antibodies, recombinant vaccines, and gene therapy products.     

Genomics applications to biotech traits: a revolution in progress?

Twenty years since the inception of the agricultural biotechnology era, only two products have had a significant impact in the market place: herbicide-resistant and insect-resistant crops. Additional products have been pursued but little success has been achieved, principally because of limited understanding of key genetic intervention points. Genomics tools have fueled a new strategy for identifying candidate genes. Primarily thanks to the application of functional genomics in Arabidopsis and other plants, the industry is now overwhelmed with candidate genes for transgenic intervention points. This success necessitates the application of genomics to the rapid validation of gene function and mode of action. As one example, the development of C-box binding factors (CBFs) for enhanced freezing and drought tolerance has been rapidly advanced because of the improved understanding generated by genomics technologies.     

The commercialization of genome-editing technologies

The emergence of new gene-editing technologies is profoundly transforming human therapeutics, agriculture, and industrial biotechnology. Advances in clustered regularly interspaced short palindromic repeats (CRISPR) have created a fertile environment for mass-scale manufacturing of cost-effective products ranging from basic research to translational medicine. In our analyses, we evaluated the patent landscape of gene-editing technologies and found that in comparison to earlier gene-editing techniques, CRISPR has gained significant traction and this has established dominance. Although most of the gene-editing technologies originated from the industry, CRISPR has been pioneered by academic research institutions. The spinout of CRISPR biotechnology companies from academic institutions demonstrates a shift in entrepreneurship strategies that were previously led by the industry. These academic institutions, and their subsequent companies, are competing to generate comprehensive intellectual property portfolios to rapidly commercialize CRISPR products. Our analysis shows that the emergence of CRISPR has resulted in a fivefold increase in genome-editing bioenterprise investment over the last year. This entrepreneurial movement has spurred a global biotechnology revolution in the realization of novel gene-editing technologies. This global shift in bioenterprise will continue to grow as the demand for personalized medicine, genetically modified crops and environmentally sustainable biofuels increases. However, the monopolization of intellectual property, negative public perception of genetic engineering and ambiguous regulatory policies may limit the growth of these market segments.     

生物医药产业发展态势与对策

当今许多国家政府已经把生物医药产业作为新的经济增长点来培育,通过采取不同政策和措施加速生物医药产业的发展。在我国政府相关利好政策的鼓励刺激和资金扶持下,我国生物医药产业有望加快走出经济危机的低谷,迎来快速发展期;在政府的引导下,构建生物产业技术创新战略联盟,推进资源整合和优势互补;多个高科技生物医药产业园区建设蓬勃,形成和集聚了一批具有较强实力的创新型企业,有力地带动了全国生物医药产业的发展和技术创新能力的提高。我国生物医药产业发展的重点要在产学研结合、前沿生物技术方面、市场准入政策和规范市场竞争秩序,以及高素质人才队伍的建设方面有所突破。根据市场导向,国家出台和制定相应的产业发展规划和政策,鼓励生物产业发展,加快国家生物医药产业基地建设;制定有关优惠政策,鼓励生物技术企业多种渠道和形式解产业发展资金问题;建立生物医药产业资源共享的机制,加强沟通与公共平台建设;发挥龙头企业的作用,支持大企业的收购兼并;加强相关法律法规建设,完善生物安全法和知识产权制度等一些措施来应对我国生物产业的快速发展。     

What should and what can biotechnology contribute to chemical bulk production?

Abstract: In terms of the chemical industry most biotech products have a fine chemical or even speciality character. Nevertheless there is at least one striking example of a fermentation-derived bulk chemical, bio-ethanol, which provides an excellent case study of the economic and technological prerequisites which biotechnology has to attain as a supplier to the chemical marketplace. The competitive position of existing and new products produced from renewable resources through biotechnological conversion methods will depend on its market acceptance - overall environmental compatibility and cost performance. In order to provide significant contributions to chemical bulk production beyond 2000, biotechnologists and chemical engineers are requested to search for new products, new processes to existing products and new technologies to overcome present cost constraints in fermentation, bioconversion and downstream processing.     

Global unbalance in seaweed production,research effort and biotechnology markets

Exploitation of the world's oceans is rapidly growing as evidenced by a booming patent market of marine products including seaweed, a resource that is easily accessible without sophisticated bioprospecting technology and that has a high level of domestication globally. The investment in research effort on seaweed aquaculture has recently been identified to be the main force for the development of a biotechnology market of seaweed-derived products and is a more important driver than the capacity of seaweed production. Here, we examined seaweed patent registrations between 1980 and 2009 to assess the growth rate of seaweed biotechnology, its geographic distribution and the types of applications patented. We compare this growth with scientific investment in seaweed aquaculture and with the market of seaweed production. We found that both the seaweed patenting market and the rate of scientific publications are rapidly growing (11% and 16.8% per year respectively) since 1990. The patent market is highly geographically skewed (95% of all registrations belonging to ten countries and the top two holding 65% of the total) compared to the distribution of scientific output among countries (60% of all scientific publications belonging to ten countries and the top two countries holding a 21%), but more homogeneously distributed than the production market (with a 99.8% belonging to the top ten countries, and a 71% to the top two). Food industry was the dominant application for both the patent registrations (37.7%) and the scientific publications (21%) followed in both cases by agriculture and aquaculture applications. This result is consistent with the seaweed taxa most represented. Kelp, which was the target taxa for 47% of the patent registrations, is a traditional ingredient in Asian food and Gracilaria and Ulva, which were the focus of 15% and 13% of the scientific publications respectively, that are also used in more sophisticated applications such as cosmetics, chemical industry or bioremediation. Our analyses indicate a recent interest of non-seaweed producing countries to play a part in the seaweed patenting market focusing on more sophisticated products, while developing countries still have a limited share in this booming market. We suggest that this trend could be reverted by promoting partnerships for R and D to connect on-going efforts in aquaculture production with the emerging opportunities for new biotech applications of seaweed products.     

Commercial development of microalgal biotechnology: from the test tube to the marketplace

While humans have taken limited advantage of natural populations of microalgae for centuries (Nostoc in Asia and Spirulina in Africa and North America for sustenance), it is only recently that we have come to realize the potential of microalgal biotechnology. Microalgal biotechnology has the potential to produce a vast array of products including foodstuffs, industrial chemicals, compounds with therapeutic applications and bioremediation solutions from a virtually untapped source. From an industrial (i.e. commercial) perspective, the goal of microalgal biotechnology is to make money by developing marketable products. For such a business to succeed the following steps must be taken: identify a desirable metabolite and a microalga that produces and accumulates the desired metabolite, establish a large-scale production process for the desired metabolite, and market the desired metabolite. So far, the commercial achievements of microalgal biotechnology have been modest. Microalgae that produce dozens of desirable metabolites have been identified. Aided by high throughput screening technology even more leads will become available. However, the successes in large-scale production and product marketing have been few. We will discuss those achievements and difficulties from the industrial point of view by considering examples from industry, specially our own experience at Mera Pharmaceuticals.     

Chemicals from biotechnology: molecular plant genetics will challenge the chemical and the fermentation industry

 Industrial biotechnology has evolved as a significant manufacturing tool for products like fuel-grade ethanol, organic acids and bulk amino acids, but most items are still speciality products for food and pharmaceutical applications. Current development projects within the chemical industry, including lactic acid and 1,3-propanediol based polymers and plastics, indicate that new biotechnological processes and products may soon approach the market place, clearly targeted at the leading petrochemical bulk outlets. This is flanked by a strategic shift by the major chemical companies in to “life sciences”–pharmaceuticals, agrochemicals and the seed business as well as biotech fine chemicals. The recent tremendous achievements in molecular plant genetics and transgenic crop breeding will boost agro-biotechnology, agriculture and renewable raw materials as compelling projects for chemistry and biotechnology. New plant-based production routes may challenge established chemical and biochemical domains, but at the same time open new horizons to valuable feedstocks, intermediates and end-products. Received: 16 October 1998 / Received revision: 3 December 1998 / Accepted: 5 December 1998     

Management strategies for agricultural biotechnology in small countries. A case study of Israel

Agricultural biotechnology is concentrated in four major countries. This paper suggests strategies for developing it in small countries, based on analysis of the world trends and the characteristics of small countries. Israel is presented as a specific case study. The main relevant trends are domination by big companies, consumer concerns on genetically modified foods, and focusing on consumer benefits and specific market niches. Small countries' disadvantages include companies that are too small to benefit fully from research, difficulty in raising funds, lack of infrastructures and experienced management personnel, and public sector research organizations that are unsuitable for commercializing research. The recommended strategies include: developing a large number of low-volume products and small market niches, forming partnerships with intermediaries (such as food companies), specializing in intermediate products (such as the seed or the gene patent), and conducting market research and cost-benefit analysis in advance. Additional strategies include developing benefits that are unique to genetically modified foods and focusing on benefits specifically for consumers who accept genetically modified foods, rather than on benefits for the average consumer. A national representative organization could buy and rent out expensive equipment, finance specific projects in return for the commercial rights, and perform collective marketing research and marketing. Israel has the advantages of a successful agricultural sector and complementary scientific research, and should focus on those fruits, vegetables, and flowers for which it already has the experience and infrastructure.     

Callus conclusion

For some years students of science and industry have been predicting the pervasive impact of biotechnology on the health care industry. Much has been discussed about the role biotechnology will play in industrial process, diagnostics, and pharmaceutical products. This review examines two branches of biotechnology which are emerging in the in-vitro diagnostics arena which are likely to bear edible fruit in the current decade—monoclonal antibodies and DNA probes.     

2015年度中国医药市场发展蓝皮书——产业经济部分 （ Ⅰ ）

从产业经济角度,包括医药工业总产值、医药工业销售收入、医药工业盈利水平、医药流通行业销售规模、医药商业效益水平、     

White biotechnology: differences in US and EU approaches?

Several predominantly political movements advocate white, or industrial, biotechnology as a means to alleviate economic, ecological and societal problems in petroleum-dependent industrialized nations worldwide. US and European approaches differ significantly and we believe that, in the long-term, only economic drivers will be able to bring about the broad use of renewable resources and a bio-based economy. As long as the cost of fossil fuel and feedstock for key chemicals have not passed their respective critical thresholds, industrial biotechnology and its products will need political support and funding, particularly in the energy and bulk-chemicals sectors. Other uses of industrial biotechnology, however, such as biocatalytic conversions of fine and specialty chemicals and the manufacture of high-value products, such as nutriceuticals, cosmeceuticals and performance chemicals offer dynamic growth opportunities both for established chemical industries, as well as emerging entrepreneurial enterprises.     

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.