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PubMed1990

Uses of biotechnology and technology transfer to keep food safe.

The era of biology is composed of 1) the definition of molecular laws of biology, 2) the exponential expansion of the data base, and 3) the establishment of the first generation molecular and cellular tool kit; this era is driving the development and commercialization of biotechnological products and processes for agriculture and the food system. These products and processes should have a major impact in maintaining and improving food safety. Several meeting and organizational initiatives on biotechnology and food safety are summarized. Possible roles of biotechnology in areas of food safety involve microbial contaminants, nutritional quality, natural antimetabolites, allergens, toxicants, and synthetic chemical residues. Biotechnology will have an impact on all these areas through both improved ability to measure as well as to modify microbes, animals, and plants used as food. Diagnostics for microbial contaminants and biobased alternatives to synthetic chemicals are most advanced. However, all these biotechnological products and processes for food safety are in very early stages of development and commercialization.

Animals↗
PubMedDate not supplied

Ethical limitations in patenting biotechnological inventions.

In order to connect ethical considerations with practical limits to patentability, the moral judgement should possibly move from the exploitation of the invention to the nature and/or objectives of Research and Development (R&D) projects which have produced it: in other words, it appears quite reasonable and logical that Society is not rewarding unethical R&D activities by granting intellectual property rights. As far as biotechnology R&D is concerned, ethical guidance can be derived from the 1996 Council of EuropeOs OConvention for the protection of human rights and dignity of the human being with regard to the application of biology and medicineO, whose Chapter V - Scientific research - provides guidelines on: i. protection of persons undergoing research (e.g. informed consent); ii. protection of persons not able to consent to research; iii. research on embryos in vitro. As far as the specific point of patenting biotechnology inventions is concerned, the four exclusions prescribed by Directive 98/44/EC (i.e. human cloning, human germ-line gene therapy, use of human embryos for commercial purposes, unjustified animal suffering for medical purposes) are all we have in Europe in terms of ethical guidance to patentability. In Italy, in particular, we certainly need far more comprehensive legislation, expressing SocietyOs demand to provide ethical control of modern biotechnology. However it is quite difficult to claim that ethical concerns are being raised by currently awarded biotechnology patents related to living organisms and material thereof; they largely deal with the results of genomic R&D, purposely and usefully oriented toward improving health-care and agri-food processes, products and services. ONo patents on lifeOO can be an appealing slogan of militants against modern biotechnology, but it is far too much of an over-simplified abstraction to become the Eleventh Commandment our Society.

Biotechnology↗
PubMed2000

Biotechnology stock prices before public announcements: evidence of insider trading?

BACKGROUND: Unique financial challenges faced by biotechnology companies developing therapeutics have contributed to the creation of a highly sensitive market, where stock prices are capable of great fluctuation. The potential for significant financial reward and the nature of the scientific review process make this industry susceptible to illegal share trading on nonpublic information. We examined stock prices of biotechnology products before and after announcement of Phase III clinical trial and Food and Drug Administration (FDA) Advisory Panel results for indirect evidence of insider trading. METHODS: Biotechnology stock prices were recorded for 98 products undergoing Phase III clinical trials and 49 products undergoing FDA Advisory Panel review between 1990 and 1998. Prices were recorded for 120 consecutive trading days before and after public announcement of these two events. We compared the average change in stock price of successful products ('winners') with unsuccessful products ('losers') before the public announcement of results for both critical events. RESULTS: The difference between average stock price change from 120 to 3 days before public announcement of results of Phase III clinical trial winners (+27%) and losers (-4%) was highly significant (P = 0.0007). A similar but non-significant difference was observed between the average stock price of winning (+27%) and losing products (+13%) before FDA Advisory Panel review announcements (P = 0.25). CONCLUSIONS: Our results provide indirect evidence that insider trading may be common in the biotechnology industry. Clinical investigators may wish to consider this issue before participating in any equity position in the biotechnology industry, especially if they are going to perform research for those companies.

Biotechnology↗
PubMed2004

Biotechnology-based odour control: design criteria and performance data.

As neighbouring areas continue to encroach upon wastewater treatment plants, there is an increasing need for odour control to mitigate potential negative offsite odorous impacts. One technology that is gaining widespread acceptance is biotechnology, which utilises the inherent ability of certain microorganisms to biodegrade offensive odorous compounds. Two main advantages of this form of treatment over other odour control technologies include the absence of hazardous chemicals and relatively low operation and maintenance requirements. The purpose of this paper is to provide information related to odour control design criteria used in sizing/selecting biotechnology-based odour control technologies, and to provide odour removal performance data obtained from several different biotechnology-based odour control systems. CH2M HILL has collected biotechnology-based odour control performance data over the last several years in order to track the continued performance of various biofilters and biotowers over time. Specifically, odour removal performance data have been collected from soil-, organic- and inorganic-media biofilters and inert inorganic media biotowers. Results indicate that biotechnology-based odour control is a viable and consistent technology capable of achieving high removal performance for odour and hydrogen sulphide. It is anticipated that the information presented in this paper will be of interest to anyone involved with odour control technology evaluation/selection or design review.

Bioreactors↗
PubMed2005

Assessing ethics and animal welfare in animal biotechnology for farm production.

This paper addresses the ethical issues involved in animal biotechnology. Considerable advances in this field have been made with transgenic fish, which may be the first real test case for regulatory bodies. Intrinsic concerns about animal biotechnology are often voiced in public debate, and the paper presents and critically discusses these issues. Even though these concerns may be hard to reconcile with standards of rational argument, they might still have practical consequences for ethical policy making. Animal welfare and environmental issues are discussed as the most salient extrinsic concerns about animal biotechnology. The most serious obstacle to a good risk assessment of animal biotechnology is the extent of scientific uncertainty. Ethical assessments need to address these uncertainties upfront, and the precautionary principle provides a good criterion for responsible policies. At the end of the paper, a practical method for the ethical assessment of animal biotechnology, the so-called ethical matrix, is briefly presented and discussed.

Animal Husbandry↗
PubMed2005

Animal biotechnology: applications and economic implications in developing countries.

In most developing countries, biotechnological applications relating to livestock need to be suitable for animal owners who are resource-poor small-scale operators who own little or no land and few animals. Livestock is becoming increasingly important to economic growth in developing countries and the application of biotechnology is largely dictated by commercial considerations and socio-economic goals. Using technology to support livestock production is an integral part of viable agriculture in multi-enterprise systems. Livestock are part of a fragile ecosystem and a rich source of animal biodiversity, as local species and breeds possess genes and traits of excellence. Molecular markers are increasingly being used to identify and select the particular genes that lead to these desirable traits and it is now possible to select superior germ plasm and disseminate it using artificial insemination, embryo transfer and other assisted reproductive technologies. These technologies have been used in the genetic improvement of livestock, particularly in cattle and buffaloes, and the economic returns are significant. However, morbidity and mortality among animals produced using assisted reproductive technologies lead to high economic losses, so the principal application of animal biotechnology at present is in the production of cheap and dependable diagnostic kits and vaccines. Several obstacles limit the application of biotechnology at present: there is a lack of infrastructure and insufficient manpower, so funding is needed if resource-poor farmers are to benefit from biotechnology.

Animal Husbandry↗
PubMed1989

[Health risks in the biotechnological industry].

Biotechnology has been defined as the application of biological organisms, systems or processes to manufacturing and service industries. In considering health aspects of biotechnological development it must be underlined that the use of microorganisms in traditional industries, such as the production of food, bread, beer and dairy products, has not added significantly to the more usual industrial hazards. The risk factors encountered in the biotechnology industry can be defined as general, i.e., common to other industrial activities, and specific, i.e., depending on the presence of microorganisms and/or their metabolic products. The specific health risks vary according to the type of process, but can be grouped into three main categories: immunological diseases, toxic effects; pathological effects of microorganisms. Allergic immunological diseases such as bronchial asthma, contact dermatitis, oculo-rhinitis and extrinsic allergic alveolitis are by far the most frequent and well known diseases occurring among workers employed on biotechnological production. Toxic effects were observed among workers employed on the production of antibiotics and hormones or single cell proteins, where absorption of endotoxins has been described. Infectious diseases may arise from uncontrolled dissemination of pathogenic microorganisms through aerosols, dusts, aqueous and semisolid sludge effluents from biotechnological plants. The greatest risks occur in the production of antiviral vaccines, in research laboratories and in waste-water treatment plants. Risk of pathogenic effects has also been speculated from exposure to engineered microorganisms in laboratory and environmental or agricultural applications. Safety precautions consisting of protective measures, and effective barriers of containment (both physical and biological) have to be advised according to the hazardous characteristics of the organisms.(ABSTRACT TRUNCATED AT 250 WORDS)

Biotechnology↗
PubMed1993

Strategic management of biotechnology agents.

The use of biologic response modifiers to demonstrate a value-driven approach to strategic management by pharmacists is described. To participate in decisions on the use of technology in their institutions, pharmacists must practice strategic management. This process includes environmental scanning, analysis of clinical and pharmacoeconomic data, and development of clinical management approaches. It is ideal for analyzing biologic response modifiers such as filgrastim and sargramostim. Emphasis must be placed on maximizing the fit among the products, the institution, and the health care environment. Pharmacists will find plentiful opportunities for clinical management with biotechnology agents. Practitioners who specialize in determining the total cost of care by using pharmacoeconomic methods are needed, as are practitioners trained to monitor the complicated biotechnology agents. Also, the institution needs to forecast accurately the impact of emerging biotechnology agents. If pharmacists can develop and control clinical, pharmacoeconomic, and reimbursement information databases for biotechnology agents, the pharmacy profession will be in a strong position to meet the challenges of biotechnology and realize the inherent opportunities.

Biotechnology↗
PubMed1993

[Biotechnology and animal health].

The development of the first vaccines for use in animals, by Louis Pasteur at the end of the 19th Century, was an initial step in applying biotechnology to animal health. However, it is only much more recently that decisive progress has been made in finding applications for biotechnology, in both detecting and preventing infectious and parasitic diseases. This progress has shown the way to developing a range of procedures, the application of which will benefit the health of domestic and wild animals, enhance the well-being of companion animals, develop the performance of sporting animals and improve the productivity of farm animals, while also serving to protect human health. Such progress results from the increasingly rapid application of knowledge gained in the material and life sciences, all of which contribute to the multidisciplinary nature of biotechnology. Similarly, reagents and diagnostic techniques have been made more specific, sensitive, reproducible, rapid and robust by updating them through recent discoveries in immunology, biochemistry and molecular biology (monoclonal antibodies, nucleic probes, deoxyribonucleic acid amplification and many more). The development of new vaccines which combine efficacy, duration of protection, innocuity, stability, multivalence and ease of use (subunit vaccines, recombinant vaccines, synthetic vaccines and anti-idiotype vaccines) has resulted from recent progress in immunology, immunochemistry, molecular biology and biochemistry. Finally, the availability of new anti-infective, anti-parasitic agents and immunomodulatory therapeutic agents (capable of stimulating the specific and non-specific defence mechanisms of the body) demonstrates that biotechnology is continuing to find new applications in the field of animal health. New diagnostic techniques, vaccines and therapeutic substances are the most immediate applications of knowledge which may, in the future, extend to the development of transgenic animals of revised genetic potential, which will be more resistant to diseases and more productive. The ultimate aim of biotechnology applied to animal health and animal production is to protect human health, preserve the environment and ensure the health and well-being of animals.

Animals↗
PubMed1996

An overview of health-related industrial biotechnology in Latin America and the Caribbean.

There is some uncertainty about the extent to which Latin America and the Caribbean have participated in the advances of health-related industrial biotechnology. This article reviews the available literature and seeks to provide an overview of the prevailing situation. In general, national governments and multinational agencies have provided most of the health-related biotechnology investments within this region. Efforts to achieve technology transfers, a subject of prime concern, have been developed by a number of programs including the WHO Special Program for Research and Training in Tropical Diseases, the UNDP/UNESCO/UNIDO Regional Biotechnology Program for Latin America and the Caribbean; PAHO's Program for the Regional Development of Biotechnology as Applied to Health; The PAHO/WHO Expanded Program on Immunization (EPI); and PAHO's Regional System of Vaccines (SIREVA). Regarding current production capacity, some successful efforts have been made to produce a variety of therapeutic products including recombinant and natural interferons, interleukins, insulin, and recombinant streptokinase; but in general the region's current potential in this area is at best incipient and uncertain. However, the region does have a limited ability to make diagnostic products and a well-established capacity for vaccine development. Overall, this picture suggests that the region has the potential to play a small but significant role in health-related biotechnology.

Biological Products↗
PubMedDate not supplied

[Experiences in the changes of biotechnology in veterinary practice].

The transmission of old methods and the transformation of new knowledge in to animal breeding practice has an cultural tradition lasting millenniums. Each epoch had its own strategy of solving problems because progress is independent of religions and ideologies, and therefore, it can not be hindered. In the past different biotechnologies have increased progress in animal breeding exponentially, and it can be supposed that the course of the exponential curve will not change in the foreseeable future. Anyone who intends to compete internationally is compelled to use the new technologies, wherever old methods can not longer compete. The transition to the new biotechnology especially in Germany, hits limitations an two levels: on the one hand, an exaggerated desire for safety that has created the German gene law and, on the other hand the animal breeding industry that can hardly afford the expensive biotechnology because of its economic condition. It seems advisable to revise both the gene law and the expense of the technology. Animal breeding research should foster simplification (make less expensive) of biotechnology, and politicians should ask weather it is necessary for the gene sector to migrate further abroad. In animal breeding, the gene transfer is practical (e.g., liposome mediated gene transfer via sperm cells) because of its low costs, and so it is absurd not to allow its use. In Germany, transgenic individuals have to bee discarded at the knackery, whereas in the Netherlands heifers derived from the bull HERMAN, that is transgenic for lactoferrin are allowed to calf (and produce milk). Currently, gene transfer is not a viable alternative because of the negative emotional impact of biotechnology. Only someone who uses this technique may be responsible for handling and creating it without having, therefore, to overstep ethical borders.

Animals↗
PubMed1997

Modern pharmaceutical biotechnology. Situation worldwide and in Germany 1995.

A variety of new diagnostics and drugs have been developed with the aid of modern biotechnology which has opened up new medical possibilities and will yield novel solutions in the future. The remarkable dynamics of the innovation process in the pharmaceutical sector is reflected by the number of drugs under development. In 1995, 771 projects were known to be in development worldwide. The leadership of North America in research and development of drugs from modern biotechnology is clearly demonstrated. Whereas the number of development recombinant DNA products remained practically constant in the triade (North America, Europe, Japan), the number of preclinical and clinical somatic gene therapy projects increased considerably in 1995 compared to 1994 in the United States and in Europe; Japan is virtually absent in this new emerging research field. In Europe, the vast majority of drugs from modern biotechnology, are developed in Great Britain, Germany, Switzerland, France, the Netherlands, and Italy. The number of gene therapy projects show a remarkable growth of more than 60% in 1995 compared with 1994; at the same time, the absolute and relative share of recombinant DNA products decreased distinctly. In Germany, about two thirds of the development of biotechnological drugs are conducted in cooperation with a foreign partner, mostly hightech companies from the United States. A variety of drugs manufactured with modern biotechnology, however, has not only provided significant medical progress and has closed therapeutic gaps but has also demonstrated considerable economic success. In 2000, further significant growth is expected especially for growth factors and cytokines.

Biotechnology↗
PubMed1997

The future of biotechnology in Europe.

At the end of September '96, the Club de Bruxelles held a conference ("The Future of Biotechnologies in Europe") to discuss the present development and the future of biotechnology in Europe. The meeting was intended to serve as a forum for the preparation of the 5th EU framework ("Inventing Tomorrow"), which is currently being set up under the leadership of Edith Cresson. The aim of the conference was to underline the necessity of concentrating and reorganizing research in the field of biotechnology, thus focusing future research activities in order to secure Europe's competitiveness in the world market. The conference was attended by 350 participants from all over Europe, representing academia, industry, environmental organizations and consumer groups. Lectures were held by representatives from academic and industrial research and a variety of work groups of the European Parliament. The speakers and participants were mainly chosen to promote the dialogue between the different groups. The objectives were the creation of a common basis for further debate in the field of biotechnology and the preparation of future consent. Once again, this conference emphasized the need to inform the public as a prerequisite for the acceptance of biotechnology and its various aspects.

Biotechnology↗
PubMed1985

Biotechnology in pharmaceuticals: the Japanese challenge.

The products of biotechnology are being developed for new diagnostics and therapeutics, and it is predicted that they will have great impact on the pharmaceutical industry. In the United States, pharmaceutical companies are incorporating biotechnology into their research and development programs, often with the contractual assistance of small biotechnology firms. Their strongest competition is arising in Japan, where there are now concerted government and industry efforts to expand biotechnology capabilities and to optimize commercialization. Strategies used by the United States and Japan to incorporate biotechnology into their pharmaceutical industries are examined and compared.

Drug Industry↗
PubMed2001

Food biotechnology: dietitians' resource needs as determined by selected Canadian key informants.

In a 1996 quantitative survey, we assessed selected Canadian dietitians' knowledge and attitudes toward biotechnology, particularly genetically altered foods. The results showed that, on average, dietitians held unfavourable attitudes and were concerned about safety and labelling issues. In the current study, qualitative methodology was used to explore dietitians' views on controversial issues and to investigate the adequacy of current biotechnology resources. Nationwide telephone interviews of 22 key informant dietitians were conducted in February and March 1999. Issues covered were food safety and quality, labelling, regulations, food production, education, and biotechnology resource needs. Findings indicated that dietitians' perspectives on biotechnology are diverse nationwide. Views about how biotechnology may affect small producers, the local economy, food choices, and food quality varied from very positive to very negative. Dietitians indicated a need for more education through discussions involving critical analysis and debate by various stakeholders. Respondents agreed that the national organization, Dietitians of Canada, has a role to play in continuing education. Most participants felt that more concise, balanced, and objective resources are needed. Further exploration of dietitians' educational needs would help in the development of appropriate educational materials and programs for nutrition professionals.

Canada↗
PubMed1992

Mass spectrometric methodologies for the analysis of biotechnologically produced protein pharmaceuticals.

The biotechnological production of protein pharmaceuticals is: i) initially a research problem, to which Chemistry is essential; ii) second, a problem of "quality control". The concept of "quality control" in terms of biotechnological products is quite different from the control of traditional products as there is still no history of the safety of the long term effects of these products in man. The "quality control" of a biotechnological product refers both to the individual production process and to the product itself. The methods for "quality control" can very greatly for two different processes, even if they lead to the same product. The "quality control" of a biotechnological product is concerned above all with the following: i) development and characterization of the production of recombinant organism; ii) culture and fermentation control, including the control of all equipment and product used; iii) control of the recovery and purification processes; iv) structural control of the final product. Mass spectrometry, belonging widely to the chemical sciences, plays an important role in biotechnology because of its capability to set-up several fast, sensitive and specific analytical and structural methods, which are invaluable for the full characterization of proteins, representing the ultimate objective of genetic manipulation. This paper review some recent studies concerned with the extensive use of mass spectrometry for the structural analysis of recombinant proteins of pharmaceutical interest.

Mass Spectrometry↗
PubMed1990

Review of biotechnology applications to nuclear waste treatment.

This paper gives an overview of the feasibility of the application of biotechnology to nuclear waste treatment. The contents are based on a report which PA Technology carried out for the Department of the Environment (DoE Reference: DoE/RW/88.008 Sector No 2.3). Many living and dead organisms accumulate heavy metals and radionuclides. The controlled use of this phenomenon forms the basis for the application of biotechnology to the removal of radionuclides from nuclear waste streams. Indeed, biotechnology offers a series of new opportunities for removal of radionuclides from dilute aqueous process effluents. Such technology is already used for heavy metal removal on a commercial basis and could be optimised for radionuclide removal. An overview of biotechnology areas, namely the use of biopolymers and biosorption using biomass applicable to the removal of radionuclides from industrial nuclear effluents is given. The potential of biomagnetic separation technology, genetic engineering and monoclonal antibody technology is also to be examined. The most appropriate technologies to develop for radionuclide removal in the short term appear to be those based on biosorption of radionuclides by biomass and the use of modified and unmodified biopolymers in the medium term.

Biotechnology↗
PubMed2000

History of biotechnology in Austria.

Austria has contributed significantly to the progress of the biotechnologies in the past and is actively engaged in doing so today. This review describes the early history of biotechnology in Austria, beginning with the Vienna process of baker's yeast manufacture in 1846, up to the achievements of the 20th century, e.g. the submerged vinegar process, penicillin V, immune biotechnology, biomass as a renewable source of fermentation products (power alcohol, biogas, organic acids etc.), biopulping, biopolymers, biocatalysis, mammalian cell technology, nanotechnology of bacterial surface layers, and environmental biotechnology.

Acetic Acid↗