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PubMed1993

Biotechnology in the Andean Group: common policies and instruments.

Although applications of biotechnology have taken a slower pace than initially anticipated, they certainly hold potentials for contributing to the social welfare and economic growth of all nations. Aware of such potentials, the andean countries (Bolivia, Columbia, Ecuador, Peru and Venezuela) individually and collectively, within their economic integration process, are making efforts to develop this new technology area. At the national level, science and technology policies and strategies are being revamped to create an appropriate environment for the development and application of biotechnology and several projects are under execution. These efforts still need, however, further political support and investment. In 1969 the andean countries established an economic integration agreement (the Cartagena Agreement), which included technology as one of its main concerns. For 22 years conceptual and operational developments have taken place creating joint capabilities in many technology areas, including biotechnology. In the last two years the pace has slowed down and is not accompanying national efforts. This is particularly serious as no country can by itself fully develop biotechnology. In spite of current difficulties the Andean Group is well placed to accelerate the development of biotechnology through the application of existing policies and legislation at communitarian level.

Biotechnology↗

PubMed2006

On the cross-fertilization between biotechnology and immunology: current situation in Cuba.

Biotechnology has created opportunities for new therapeutic products. More than half of biotechnological products being developed intend some manipulation of the immune system. Vaccines are 29% of the worldwide biotechnology pipeline and more than 50% of Cuban biotechnology pipeline. Current understanding of antigen presentation and the maturation of dendritic cells has opened the way for a more rational design of new adjuvants, intended not only to deliver the antigen to antigen presenting cells (APC) and to induce APC maturation, but also to direct lymphocyte differentiation towards either Th1 or Th2 phenotypes, and to deal with disease-induced immunodepression. Therapeutic cancer vaccines are a field in which new adjuvants and new immunization schedules will be tested. This knowledge will be pertinent for other vaccines, so fertilizing biotechnology with the indication of the new molecules that need to be manufactured.

Adjuvants, Immunologic↗

PubMed1999

New technologies in medicine: biotechnology and nanotechnology.

In February 1997, researchers created Dolly, a lamb cloned from the DNA of an adult sheep. This was supposed to be impossible (or at least generations away), but suddenly it was here--a clone of a higher mammal. Whatever Dolly's ultimate significance, she conclusively demonstrated the growing power of biotechnology. Many have come to the conclusion that advances in biotechnology will fundamentally transform medicine during the coming decade. Society is in the midst of a technical revolution that will have the same relevance as the development of the printing press, the internal combustion engine, and the microprocessor. Computers have become the key tools in the accelerating progress that is occurring in the field of biotechnology. At the same time, genetic, evolutionary, and other biologic processes are providing new models for the development of computer hardware and software. Today represents the early stages of what has been called the "bionic convergence": the convergence of the biologic revolution with the information revolution, the joining of biology with electronics. Virtually everything that is important to health care practitioners and patients--diagnostic techniques, means of understanding disease causes, methods of treatment, approaches to prevention, health care facility design, medical education, and legal and ethical issues--will be changed by the revolutions currently underway in the fields of biotechnology and genetic medicine. The following monograph includes several forecasts about a range of possible opportunities that may have enormous effects on health care during the next century. These forecasts address the potential impacts of biotechnology on disease detection and diagnosis, treatment, prevention, nanotechnology, and other areas of medical significance. Every area of beneficiary care will be affected as the changes implied by these forecasts begin to develop. Beneficiary care will continue to see the emergence of a "forecast, prevent, and manage" paradigm. The emphasis will be on disease prevention, health promotion, and the creation of healthy communities. New diagnostic and treatment opportunities will be available as a consequence of breakthroughs in genetic medicine. The health care system will view health as a whole, as a person's overall sense of well-being--an entity that encompasses much more than the absence of symptoms.

Biotechnology↗

PubMed2003

[Current framework of biotechnology products according to the available pharmacoeconomic studies].

BACKGROUND AND OBJECTIVE: Biotechnologic drugs have a high impact in health system because they contribute in new indications as well as in its high cost. The study's aim is to do a descriptive analysis from the pharmacoeconomic studies. The objective of the study was to establish the standards of efficiency and utility, as well as to know its therapeutic usefulness and rationale. MATERIAL AND METHOD: The detection and selection of originals has been made through repeated searches in MEDLINE (PubMed) with every one of the different biotechnology products crossing the product name with life, year and saved. In function of the cost for year of life saved (YLS) were defined categories: saving of cost (< 0$/YLS), highly cost-effectiveness (0-20000$/YLS), cost-effectiveness (20001-40000$/YLS), doubtfully cost-effectiveness (40001-60000$/YLS), and no cost-effectiveness (> 60001$/YLS). RESULTS: There are published figures only in 31% of the total of the searched biotechnological drugs. In 2 clinic conditions the drug reduces the cost, in 33 is highly cost-effectiveness, in 11 is cost-effectiveness, in 4 occasions is doubtfull cost-effectiveness and in 14 is no cost-effectiveness. CONCLUSIONS: In spite of the high heterogeneity of methodology used in the pharmacoeconomic studies about biotechnological products, in the majority of the clinic situations evaluated we observed a good cost-effectiveness relation in the use of the biotechnological products.

Biological Products↗

PubMed2003

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.

Animals↗

PubMed2002

The socio-economic landscape of biotechnology in Spain. A comparative study using the innovation system concept.

Biotechnology is becoming a crucial factor for the innovation strategies of the industrialised countries. Thus, the analysis of the sector is gaining relevance for the identification of the technological strength and potential of a country (or region) in a context of globalisation. A specific national case study may serve for more general comparative analyses. We have selected the case of Spain as illustrative of the complexity and differences existing in Europe. By using the analytical framework of the "national systems of innovation" concept, we have performed a multistep analysis of the biotechnology sector in Spain, focussing first on regions of Madrid and Cataluña which together account for more than 50% of the sector in Spain. The firms in both regions have followed a common strategy based on diversification and investment in R&D and innovation, so as to be able to compete in an international and competitive environment. There are, however, some interesting differences between the two subsectors; the one from Cataluña being more based on industrial traditions, and the one from Madrid characterised by the emergence of more specialised firms. The study has been extended to the remainder of Spanish firms for comparative purposes. The case of Spain is illustrative of the divergences existing in the biotechnology sector in Europe. A comparison is made with the structural and organisational characteristics of the biotechnology sector in several European countries. It shows that there is diversity in the pattern of commercialisation between countries and within regions of countries. Understanding these differences may assist the design of appropriate policies to promote the development of biotechnology in Europe.

Adult↗

PubMed2002

Environmental biotechnology: the ongoing quest.

Environmental biotechnology, until now, has primarily focused on the development of technologies to treat aqueous, solid and gaseous wastes. At present, the basic knowledge on how biotechnology can handle these wastes has been acquired and the focus is now on the implementation of these processes as 'best available technology not entailing excessive costs' (BATNEEC) in the framework of strict and transparent environmental legislation. New environmental challenges continue to evolve, as it becomes clear that waste streams should be tackled in an overall holistic way. New technologies to reach this goal are currently under development. Novel aspects with respect to the domain of water treatment are, for example, the biomembrane reactor technology and the newly discovered processes to remove nitrogen by means of anaerobic ammonium oxidation. Also, most challenging is the continuing strive for re-use of treated wastewater. Indeed, water shortage is emerging in an increasing number of countries all over the world and necessitates the short cycling of water. Finally, biotechnology has a key role to play in the novel approaches to design wastewater treatment based on decentralised sanitation and reuse (DESAR). Solid waste is a major challenge worldwide. The implementation of anaerobic digestion to treat biowastes has become a grown-up technology. New approaches in which biotechnological processes are linked to physical processes, such as plasma technology, certainly deserve special attention for the coming decades. Soil and sediment clean up by means of biostimulation/remediation/augmentation is now well established. Certainly, a number of prospects need to be further explored, such as the use of special energy sources to stimulate in situ the microbial community and the seeding of knowledge to the in situ community by means of horizontal gene transfer mechanisms. A number of waste gases can be handled by biofilter systems. Biological treatment of wastegases is also evolving, inasmuch as that besides conventional chemical pollutants, now also highly problematic chemicals (even dioxins) can be dealt with through proper biotechnological approaches. A remarkable new potential is the use of well designed probiotics to upgrade aquaculture and together with conventional biological water treatment processes, to guarantee the overall water quality of this domain of food production.

Air Pollution↗

PubMed1997

Biotechnology: a special case for health technology assessment?

Many substances produced naturally in a wide range of living organisms have been identified to be of benefit in the treatment of human disease. Current health biotechnologies recreate DNA-recombinant cellular processes in laboratory settings to produce 'natural' therapeutics: these are potentially a step forward from traditional pharmacology which has developed synthetic analogues or sought to extract products from donor material. However, with increasing financial pressures, decision makers require evidence that the benefits of biotechnologies justify their costs. The challenges experienced when evaluating the cost-effectiveness of biotechnologies are explored with reference to three examples: HA-1A human monoclonal antibody, erythropoietin and DNase. Difficulties in economic evaluation are similar to those experienced with conventional pharmaceuticals: use of short-term clinical endpoints rather than meaningful health outcomes, the artificial nature of clinical trial protocols, and uncertainty about the applicability of economic data. However, early clinical and economic assessments are required by decision-makers, particularly where biotechnology products fill major gaps in therapy. The financial structure of biotechnology companies may limit movement towards adequate clinical and economic research for health technology assessment. Governments should negotiate with the industry to promote more relevant studies, and develop policies for the managed introduction of products as evidence on effectiveness and cost expands. New technologies often present additional costs requiring reallocation of existing resources. Careful resource planning is required so that cost-effective innovation are not denied to patients.

Antibodies, Monoclonal↗

PubMed2001

Assessment of biotechnology products for therapeutic use.

Biotechnology products for therapeutic use include a very diverse range of products, including growth factors, cytokines, hormones, receptors, enzymes, clotting factors, monoclonal antibodies, vaccines, DNA vaccines, gene transfer products, cell therapies and tissue/organ grafts. While some of these products are regulated as medicinal products, the regulatory status of others such as some cell therapies and tissue/organ-based products differs globally and falls within the borderline between the practice of medicine, medical devices and medicinal products. The unclear regulatory status of some products can add to the complexity of the safety assessment of such products. Conventional non-clinical testing paradigms and guidelines for small molecule development are often not relevant for biotechnology products. Guidelines relating to the non-clinical safety evaluation of biotechnology products, gene transfer products and cell therapy products are available and represent a set of general guiding principals to be applied on a case-by-case basis. The quality, safety and efficacy of biotechnology products for therapeutic use are intricately linked, far more so than for conventional medicinal products, leading to the need for increased communication between those responsible for ensuring product quality and those responsible for non-clinical safety testing. Safety issues include microbiological safety (due to the use of biological materials either during the manufacturing process or as an integral part of the products), pharmacological/ biological toxicity (due to excessive primary pharmacology or undesirable secondary pharmacology), immunogenicity and potential tumourigenicity (for example, for growth factors, immunosuppressive monoclonal antibodies and cell therapy products). Genotoxicity and intrinsic chemical toxicity are less of a problem for biotechnology products.

Biotechnology↗

PubMed1999

Genotoxicity testing of biotechnology-derived products. Report of a GUM task force. Gesellschaft für Umweltmutationsforschung.

Various aspects of genotoxicity testing of biotechnology-derived products are discussed based on information gathered from a questionnaire which was sent to about 30 predominantly European companies. Feedback was received from 13 companies on 78 compounds, mostly recombinant proteins but also on a number of nonrecombinant proteins, which had been assessed for genotoxicity in a total of 177 tests. Four of the 78 compounds appeared to elicit reproducible genotoxic effects. For one of these compounds, the activity could be related to a nonpeptidic linker molecule. No scientifically convincing rationale for the other three compounds could be established, although, at least for two compounds, their activity may be connected with the enzymatic/hormonal activity. In addition to the survey, published reports on genotoxicity testing of biotechnology products were reviewed. The data are discussed relative to whether genotoxicity testing is a valuable exercise when assessing potentially toxic liabilities of biotechnology-derived compounds. It is concluded that genotoxicity testing is generally inappropriate and unnecessary, a position which is in accordance with the available guidelines addressing this area. For the 'average' protein, electrophilic reactions are difficult to envision. Indirect reactions via DNA metabolism and growth regulation seem possible for only very specific proteins such as nucleases, growth factors, cytokines. No information on testing of different types of biotechnology-derived products (e.g., ribozymes, antisense-oligonucleotides, DNA vaccines) has been received in the questionnaires. Discussion of their potential to cause genotoxic changes was based on literature reports. Even for those products for which concerns of genotoxic/tumourigenic potential cannot be completely ruled out, e.g., because of their interaction with DNA metabolism or proliferation control, the performance of standard genotoxicity assays generally appears to be of little value. All information, including also information on the occurrence of genotoxic impurities, has been utilized to formulate a decision tree approach for the genotoxicity testing of biotechnology-derived products.

Animals↗

PubMed1995

Biotechnology domain.

Biotechnology and the use of biologically based agents for the betterment of mankind is an active field which is founded on the interaction between many basic sciences. This is achieved in coordination with engineering and technology for scaling up purposes. The application of modern recombinant DNA technology gave momentum and new horizons to the field of biotechnology both in the academic setting and in industry. The applications of biotechnology are being used in many fields including agriculture, medicine, industry, marine science and the environment. The final products of biotechnological applications are diverse. In the medical applications of biotechnology, for example, the field has been evolving in such a way that the final product could be a small molecule (e.g. drug/antibiotic) that can be developed based on genetic information by drug design or drug screening using a cloned and expressed target protein.

Animals↗

PubMed1995

The politics of patent legislation in biotechnology: an international review.

The realization of the economic value of the genetic resources has prompted an international debate about property rights to genetic resources. The international debate pertaining to patenting of genetic material is the main theme of this chapter. As a backdrop for the international debate, the chapter starts out with a summary of the main events and arguments in the expanding scope of patent legislation in biotechnological inventions. Summing up, the new biotechnologies represent a tool which meets the legal requirements for patenting biological material. From the industry's point of view, biotechnology also necessitates patenting. On the negative side, defending a patent is often a long and costly business, and the trend is that patenting will mainly benefit the bigger and stronger companies and thus weaken public control over the rapid developments in biotechnology. A central argument in the chapter is that without sophisticated biotechnological tools, trained scientists, and adequate infrastructure, patenting is, as yet, hardly a viable solution for the majority of developing countries. Gene-rich developing countries fear that developments in patent legislation will pave the way for increased Northern control over Third World natural resources. The International Convention on Biological Diversity goes some way in making amends to this situation, but the gene-poor, least developed countries may still have reason to fear that they will lose access to breeding material. In a long-term perspective, the implications may be detrimental for resource conservation in developing countries. In conclusion, the patent question seems to remain unresolved and may still be one of the most likely stumbling blocks for future ratifications and implementation of the Biodiversity Convention.

Animals↗

PubMedDate not supplied

The developing world benefits from plant biotechnology.

This article presents the view that the developing world benefits from plant biotechnology. To support this view, evidence is presented showing that plant biotechnology has already had a beneficial impact on millions of farmers of the developing world who have chosen to grow Bt cotton, resulting in fewer pesticide sprayings and increased yields and profits. Leaders, scientists, and farmers in developing countries have expressed their need for plant biotechnology, and in some developing countries, ongoing projects are applying plant biotechnology to improve indigenous crops. Nutrition education efforts should evaluate crop biotechnology from the perspective of the developing world.

Agriculture↗

PubMed2002

Controversial medical and agri-food biotechnology: a cultivation analysis.

Whether biotechnology is one or several developments is not clear. Once distinctions are required, the question is: Which one prevails? When the good, the bad, and the ugly settle, where do they fall? Evaluation implies distinction, and representation drives attitude. The controversies over biotechnology are fertile ground on which to study these issues. The imports of genetically modified (GM) soya into Europe in 1996-97 and the cloning of Dolly the sheep from adult cells in 1997 changed the symbolic environment for genetic engineering. The ensuing public controversies came to focus mainly on field trials of GM crops and food labeling. This paper will explore the relationship between quality press coverage and public perception, in particular the cultivation of the contrast between "desirable" biomedical (RED) and "undesirable" agri-food (GREEN) biotechnology in Britain. The argument draws on a systematic analysis of the British press coverage of biotechnology from 1973 to 1999 and analysis of public perceptions in 1996 and 1999. The paper concludes that the debate over GM crops and food ingredients fostered the RED-GREEN contrast among the newspaper-reading public, thereby shielding RED biotechnology from public controversy, and ushered in a realignment of the regulatory framework in 2000.

Biotechnology↗

PubMed1993

Biotechnology for developing countries. The case of the Central American isthmus.

Recent developments in the fields of chemistry, molecular biology, computer science, and communications promise to transform the way that many things will be done in the near future in diverse fields of scientific R&D. Fortunately for less developed countries (LDCs) some of the technologies involved are user friendly and safe, avoiding the need for radioactive precursors, large machines, or expensive reagents. For instance, tissue culture, polymerase chain reaction (PCR), dideoxi-sequencing, and recombinant DNA techniques have already invaded clinical laboratories, agricultural field stations, and natural history museums, even in some developing nations. Somatic cell culture for plant biotechnology and immunologic techniques for diagnosis have had wide applications for over a decade in all countries in the Central American Isthmus. More recently, recombinant DNA techniques, including PCR, have been introduced for diagnostic purposes and research at the two largest universities in Costa Rica and at other public institutions and are also used in Guatemala and Panama. Honduras and Nicaragua are only now acquiring these technologies for diagnostic purposes. Biotechnological applications in industry seem to be lagging behind, and presently no good links exist between research laboratories and industry for advanced applications. The application of biotechnologies in environmental problems is slowly underway, with molecular studies of natural wildlife populations and primary forest trees. A major effort is needed to create safe and effective ways of dealing with environmental degradation, wastes, and byproducts of tropical agriculture and industry. The creation of the National Biodiversity Institute (INBio) in Costa Rica to elaborate an inventory of flora and fauna and to prospect for useful substances provides a unique opportunity for biotechnological applications. In addition, government policies to promote biotechnological development are supported by CONICIT (National Research Council), the Ministry of Science and Technology, the newly established Costa Rican Academy of Science, and the national universities. Other countries in the region are beginning to take similar action. At the Cell and Molecular Biology Center (CIBCM) our strategy is to obtain the key components and infrastructure to handle nucleic acids and manage genetic information in databanks. Training has been an important priority during the last decade, with over 20 Central American students receiving graduate degrees in virology, molecular biology, genetics, and immunology, with support from German and Swedish governmental institutions. Diagnosis of viral diseases in cultivated plants and animals was done initially at CIBCM for research and later on a contractual basis for both the public and private agricultural sectors. DNA hybridization and PCR techniques are now replacing or being used concurrently with immunologic techniques.(ABSTRACT TRUNCATED AT 400 WORDS)

Agriculture↗

PubMed2000

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.

Biotechnology↗

PubMed2006

Chinese public understanding of the use of agricultural biotechnology--a case study from Zhejiang Province of China.

This study explores the Chinese public's perceptions of, and attitudes to, agriculture and food applications of biotechnology; and investigates the effect of socio-demographic factors on attitudes. A questionnaire survey and interviews were used in an attempt to combine quantitative analysis with qualitative review. The main finding of this study is that the Chinese population has a superficial, optimistic attitude to agricultural biotechnology; and that, in accordance with public attitudes, a cautious policy, with obligatory labelling, should be adopted. The study reveals that education is the factor among socio-demographic variables with the strongest impact on public attitudes. Higher education leads to a more positive evaluation of GM (genetically modified) foods and applications of biotechnology with respect to usefulness, moral acceptability, and suitability for encouragement. In addition, public attitudinal differences depend significantly on area of residence. Compared with their more urban compatriots, members of the public in less developed areas of China have more optimistic attitudes, perceive more benefits, and are more risk tolerant in relation to GM foods and agricultural biotechnology. Finally we obtained a very high rate of "don't know" answers to our survey questions. This suggests that many people do not have settled attitudes, and correspondingly, that the overall public attitude to agricultural biotechnology and GM foods in China is at present somewhat unstable.

Adolescent↗

PubMed1990

Regulation of biotechnology in the United States and Canada.

The regulation of biotechnology in the United States and Canada is based on principles that reflect respect for the new technology, yet also recognize that most traditional approaches to regulation, employing sound science and common sense, still apply. Four specific principles form the framework on which regulatory schemes are based: (1) the products of biotechnology will not differ fundamentally from unmodified organisms or from conventional products; (2) the product rather than the process shall be regulated; (3) regulation should be based on the end use of the product and will be conducted on a case-by-case basis; and (4) the existing laws provide adequate authority for regulating the products of biotechnology. This report summarizes the regulatory approaches taken in various organisms and products. Special emphasis is given to: (1) issuance of entry permits for genetically-engineered plants and micro-organisms; (2) licensing of genetically-engineered veterinary biological products; and (3) permits for movement and release into the environment. A three-category classification system is described for dealing with hybridomas and recombinant-derived products, based on their biological characteristics and safety concerns. Categories range from relatively simple inactivated recombinant animal vaccines to products using live vectors to carry recombinant-derived foreign genes that code for immunizing antigens and/or other immune stimulants. This paper stresses that few fields of contemporary science and technology hold forth more possibilities and greater expectations than biotechnology. It is therefore of utmost importance that animal health officials and scientists ensure that the products of biotechnology will not cause or transmit infectious disease, adversely affect the environment or adulterate food products.

Animals↗