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PubMed1989

Therapeutic opportunities involving cellular oncogenes: novel approaches fostered by biotechnology.

Biotechnological processes are having a major impact on many industrial sectors, including the pharmaceutical industry. The contributions of recombinant DNA and hybridoma technologies to modern therapeutics include production of natural and unnatural peptides, subunit vaccines, monoclonal antibodies and nucleic acid hybridization probes for in vitro and in vivo diagnostics and biological imaging, therapeutic monoclonal antibodies as tissue-specific delivery systems or as agents to confer passive immunity, production of therapeutic targets for rational drug design, and the use of cloned enzymes as stereospecific catalysts in large-scale production of small medicinal molecules. Biotechnological advances have led to the identification of a discrete set of genes, oncogenes, which may be essential contributing factors for a great variety and number of human cancers. In addition, biotechnological innovations are fostering the exploitation of oncogenes as novel therapeutic targets for cancer diagnosis, prognosis, and treatment. Because oncogenes are activated in transformation by either qualitative or quantitative mechanisms, however, different biotechnology-based therapeutic approaches are required for each class.

Biotechnology↗
PubMed1989

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.

Biotechnology↗
PubMed2004

Expert and public perception of risk from biotechnology.

Risk perceptions of a series of biotechnology applications were examined in a public (nonexpert) sample and an expert sample. Compared with the experts, the public perceived all biotechnology applications as more risky. Both groups perceived food-related applications to be riskier than medical applications. Compared with the public, experts perceived both food and medical applications as less harmful and more useful. Experts also judged the risks posed from medical biotechnology applications as more familiar and acknowledged by people and science. Lay estimates of the risk of food applications were predicted by potential harm, potential benefits, science knowledge, and familiarity; experts' estimates were predicted only by harm and benefits. Lay estimates of the risk of medical applications were predicted by potential harm; experts' estimates were predicted by potential benefits, number and type of people exposed, and science knowledge. We discuss the implications of the results for risk communication about and management of different types of biotechnologies.

Adult↗
PubMed2002

From yeast genetics to biotechnology.

Roots of classical yeast genetics go back to the early work of Lindegreen in the 1930s, who studied thallism, sporulation and inheritance of wine yeast strains belonging to S. cerevisiae. Consequent mutation and hybridization of heterothallic S. cerevisae strains resulted in the discovery of life cycle and mating type system, as well as construction of the genetic map. Elaboration of induced mutation and controlled hybridization of yeast strains opened up new possibilities for the genetic analysis of technologically important properties and for the production of improved industrial strains, but a big drawback was the widely different genetic properties of laboratory and industrial yeast strains. Genetic analysis and mapping of industrial strains were generally hindered because of homothallism, poor sporulation and/or low spore viability of brewing and wine yeast strains [1, 2]. In spite of this, there are a few examples of the application of sexual hybridization in the study of genetic control of important technological properties, e.g. sugar utilization, flocculation and flavor production in brewing yeast strains [3] or in the improvement of ethanol producing S. cerevisiae strains [4]. Rare mating and application of karyogamy deficient (kar-) mutants also proved useful in strain improvement [5]. Importance of yeasts in biotechnology is enormous. This includes food and beverage fermentation processes where a wide range of yeast species are playing role, but S. cerevisiae is undoubtedly the most important species among them. New biotechnology is aiming to improve these technologies, but besides this, a completely new area of yeast utilization has been emerged, especially in the pharmaceutical and medical areas. Without decreasing the importance of S. cerevisiae, numerous other yeast species, e.g. Kluyveromyces lactis, Hansenula polymorpha, Pichia pastoris, Schizosaccharomyces pombe and Yarrowia lipolytica have gained increasing potentialities in the modern fermentation biotechnology [6]. Developments in yeast genetics, biochemistry, physiology and process engineering provided bases of rapid development in modern biotechnology, but elaboration of the recombinant DNA technique is far the most important milestone in this field. Other molecular genetic techniques, as molecular genotyping of yeast strains proved also very beneficial in yeast fermentation technologies, because dynamics of both the natural and inoculated yeast biota could be followed by these versatile DNA-based techniques.

Biotechnology↗
PubMed2005

The saving power of biotechnology: on public perceptions of a field of technology.

Biotechnology emerges in the nexus of academic, political and economic interests. With its strong reliance on a human individual capable of changing matter or organisms in accordance with anticipated goals, biotechnology is closely linked with a modern notion of human agency. In this article, it is argued that in contemporary European societies, biotechnology is perceived in three distinct ways, namely as an agent, as pluripotent, and as salvific. Similar to other forms of technologies, it provides a foil for human activity and projection, but it supersedes them in a quasi religious fashion. The great fascination with the biotechnological enterprise might, thus, express a more fundamental longing for narratives providing coherence and meaning.

Biotechnology↗
PubMed1999

Challenges to the economic evaluation of new biotechnological interventions in healthcare.

The next century is likely to bring unforeseen genetic and biotechnological discoveries, with new benefits, risks and costs. This paper explores some of the problem areas that healthcare biotechnologies are likely to encounter. Biotechnological interventions may present particular difficulties when they promise a major breakthrough in therapy, since economic evaluation early in the development of such technologies is inherently uncertain. Given the structure of the biotechnology industry, the perception of the high cost of new products and unknown uncertainties, governments may need to be proactive to ensure that meaningful clinical and economic data are generated in the product research phase and to manage the introduction and diffusion stages with further evaluation and surveillance. Progress usually comes at a price: both governments and the industry should prepare for this rather than offering bland reassurances about safety.

Antibodies, Monoclonal↗
PubMed2006

Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals.

Biotechnology-derived pharmaceuticals are a well established and growing part of the therapeutic armamentarium. Beginning with recombinant versions of products such as insulin that were previously manufactured by extraction from animal and human sources, licensed biotechnology drugs and those in development now span an ever-increasing range of product types and therapeutic categories. As a consequence of this diversity, both general and product class-specific scientific guidelines have been developed on a regional (e.g. EU/US) or international (e.g. ICH - International Conference on Harmonization) basis. The current portfolio of nonclinical guidelines, particularly ICH S6, emphasizes flexibility and adaptability to the specific circumstances of the individual biotechnology product and its intended indication, taking into account factors not generally applicable to small-molecule drugs, such as pharmacodynamic responsiveness of safety and efficacy models, species specificity, and antibody formation. Guidelines developed principally with small-molecule drugs in mind may, nevertheless, have some applicability to biotechnology drugs on issues such as safety pharmacology, as well as on regulatory, procedural and dossier submission requirements. Scientific guidelines, such as those providing nonclinical guidance, are just one, albeit important, component of an increasingly complex legal/scientific environment in drug development.

Animals↗
PubMed1998

Reengineering the retail/ambulatory pharmacy for provision of biotechnology pharmaceutical services.

Biotechnology products offer both problems and opportunities for pharmacists. On one hand, they are expensive to purchase and keep on inventory. Typical compensation for outpatient prescriptions does not offset the cost of maintaining the inventory, or providing the education and training that patients often need to use biotechnology products properly. On the other hand, there are issues related to proper storage, preparation, and administration for which pharmacists are well prepared to address. Pharmacists are also convenient, trusted, and provide service at relatively low cost. Examples of special services that pharmacists can provide to improve the use of biotechnology products include patient education, injection clinics, provision of medical supplies, and predrawing syringes for patients. Patients are often sent to many providers for these services, resulting in inconvenience and fragmentation of care. If new compensation methods can be established to support more comprehensive pharmacy services, the use of biotechnology products by patients will improve.

Ambulatory Care↗
PubMedDate not supplied

Biotechnologies and genetic resources for food and agriculture.

The article stresses the complimentarity of genetic resources and biotechnologies in ensuring food security. Genetic resources are being lost at an increasing and alarming rate. A small number of crops and farm animals contribute an ever increasing percentage of human food. The conservation and sustainable use of genetic resources have many socio-economic, political, cultural and legal implications. Genetic resources are the raw material to which biotechnology is applied. Biotechnologies are increasingly protected by intellectual property rights, no such incentive for the conservation and sustainable use currently exists. The article discusses the role of the International Undertaking on Plant Genetic Resources, currently being negociated in FAO countries, and of the Code of Conduct on Biotechnology being developed by the FAO Commission on Genetic Resources for Food and Agriculture.

Agriculture↗
PubMed2001

Biotechnology--updates and new developments.

Areas of priority for intensive discovery would be the agbiotechnology and biomedical sectors using gene technology as a platform. The use of genetic manipulation in farming and the use of plants as 'pharma' factories to manufacture therapeutics would be on the rise. The human genome will continue to have a powerful impact on research and development of human diseases and healthcare. Discovery of genetics and pharmacogenomics will have great impact on drug development and will allow the prediction of the patient' s response to various drugs as well as the onset of individualised or 'designer drugs'. Human stem cells could have their cellular clocks reset by the cloning process, enhancing opportunities to grow young cells, tissues and organs for an aging population. The cellular clock could also be reset by therapeutic cloning. Bioinformatics would be a technology which would be synonymous with biotechnology. The analyses of biotechnology research would be conducted in silico and would involve the exchange of information among sophisticated computer databases. Applications of biotechnology would be even more evident in environmental technology, food development and food processing. In electronics, the use of the specificity of proteins in biochips is underway. In tandem with the explosions in research, regulatory issues, legislation and intellectual property rights will evolve to enhance the climate of discovery and innovation. Public education will have to be continually enhanced as awareness could negate any fear resulting from novel and innovative improvements from biotechnology.

Agriculture↗
PubMed2002

Bioethics and the commodification of biotechnology.

Although recent advances in biotechnology have brought with them a raft of ethical issues, other ethical challenges are arising not from new technologies, but rather from the expansion of biotechnology into "commodified" mass consumer applications, non-medical applications with no "purpose" other than entertainment or the satisfaction of consumer demand. In other words, commodity products targeted at a market that biotechnology does not currently exploit--the mass consumer market. This article will discuss two such examples of commodified biotechnology, the use of DNA sequence comparisons to construct genealogies; and the use of such comparisons to derive "ethnic" identities, and will conclude with a discussion of the possible consequences of such applications.

Biotechnology↗
PubMed1992

Current USDA procedures for licensing biotechnology-derived veterinary biologicals.

The establishment of appropriate procedures for regulating the commercialization of biotechnology products is an international issue which has been debated extensively in many countries. This paper will discuss the current procedures that have been established for the regulation of biotechnology-derived veterinary biologicals within the United States Department of Agriculture (USDA) and more specifically within Biotechnology, Biologics, and Environmental Protection (BBEP) of the Animal and Plant Health Inspection Service (APHIS). These procedures implement recent BBEP regulatory policy that has been developed to ensure risk-based regulation and avoid excessive restrictions that might curtail the development of biotechnology products.

Animals↗
PubMed1999

Religious voices in biotechnology: the case of gene patenting.

On 18 May 1995, nearly 200 religious leaders joined with leading biotechnology critic Jeremy Rifkin in a press conference named the "Joint Appeal against Human and Animal Patenting," a move that many within the biotechnology industry could only interpret as seeking to inhibit biotechnological advance. What moral and religious concerns motivated this challenge to patenting? How could the biotechnology industry understand and respectfully attend to these concerns? What values were at play in the debates that followed the joint appeal? What lessons for future dialogue can be learned from attempts at conversation between the opposing positions? This essay is a report from a Hastings Center research project that accepted the task of addressing these questions. Specifically, the project focused on the patenting of human genetic material, a subset of the issues raised by the joint appeal.

Base Sequence↗
PubMed1991

International trends in biotechnology regulation: the implications for developing countries.

Evolutionary processes have demonstrated that genetic mutations can, over time, produce a complete restructuring of the previous ecological order. The capacity of biotechnology to manipulate and transform genetic material at a far greater rate than nature is capable of suggests that careful consideration should be given to effectively controlling these technologies. This paper examines the underlying technical and philosophical concerns and arguments which underpin the development of appropriate regulations for biotechnology. The regulatory frameworks which have been set in place around the world are reviewed. Modifications which are being introduced in the light of increasing practical experience and in response to changing societal pressures are discussed. Potential negative impacts of biotechnology on developing countries are specifically addressed. A case is made for co-ordinated international efforts to develop consistent and uniform legislation for the safe and environmentally beneficial application of biotechnology on a more equitable global basis.

Animals↗
PubMed2005

Health professionals hold positive attitudes toward biotechnology and genetically engineered foods.

Few biotechnology processes have elicited the degree of controversy that genetic manipulation of food through recombinant DNA technology has. Research has shown that consumers turn to health professionals for answers to questions regarding health and nutrition. This study sought to assess the knowledge, attitudes, and beliefs of physicians (MDs/DOs), nurse practitioners (NPs), and registered dietitians (RDs) toward food biotechnology and genetic engineering (GE). Six hundred three-part, self-administered surveys were sent to health professionals holding active professional licenses. Statistical analysis included analysis of variance with Tukey's HSD and Scheffe's post hoc tests. Attitudes toward GE were positive. MDs held more positive attitudes than NPs or RDs (p = .000). MDs and NPs supported the use of GE to improve plant resistance to pests; RDs tended to support nutritional-improvement technology. All groups supported the use of GE to produce human medicines and the current Food and Drug Administration (FDA) labeling policy. No profession was more knowledgeable than another. Biotechnology holds the potential to positively affect human health. All health professionals can facilitate or diminish this process through their understanding of the technology and their ability to communicate effectively about the science and issues associated with biotechnology.

Adult↗
PubMed2005

Regulation of biotechnology by executive orders: questions about constitutionality, legality and overall fairness to the American public.

In the biotechnology field, researchers often face complex moral and social issues while pursuing their scientific goals. Congress may regulate much of that research by debating the issues and placing restraints on funding granted by the government. In modern times, our presidents have also made some of those funding decisions through the issuance of executive orders. Presidents may issue executive orders with binding legal effect, despite having little constitutional authority to do so. Unless a new president takes office, only Congress or the courts can invalidate an executive order. In the regulation-sensitive biotechnology industry, presidents may exert profound influence by announcing executive orders. Former President Clinton and President George W. Bush are just the latest presidents who have used such orders to influence biotechnology as they have deemed appropriate. In doing so, those presidents have assumed a degree of unilateral lawmaking power over an industry that is fundamentally important to every citizen. This article stresses the need for the other branches of our government to discontinue granting unconstitutional legislative power to the president, and bring more social and scientific balance to important biotechnology policy decisions.

Biotechnology↗
PubMed2006

Biotechnology entrepreneurship and ethics: principles, paradigms, and products.

Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug or technology, ethical questions arise with respect to protecting human subjects and society from danger and exploitation by researchers. As development gives way to marketing and dissemination of a new product, government regulators are pressed to get drugs and biologics through the regulatory pipeline into the market faster, walking an ethical tightrope between speed and safety. As new biotechnology products enter the market place, doctors and patients traverse yet another tightrope, that between unknown risk and the promise of benefit. And finally, patent protection is increasingly viewed as a unethical culprit in keeping prices high and depriving the global poor from lifesaving drugs and biologics. Bioethics has, to date, been largely a creation of Western research and medicine. As such it is wholly inadequate to respond to the cascade of ethical issues that flow from a vibrant biotechnology industry. And if biotechnology is in its infancy, as most believe, it is crucial that scientists, entrepreneurs and governments engage in dialogue about the ethical and societal questions raised on the road of scientific progress.

Bioethics↗
PubMedDate not supplied

[Occupational risk and prevention in the biotechnology industry: a review].

BACKGROUND: The biotechnology industry has expanded greatly in the last 20-30 years and has led to a number of applications in different sectors of work, i.e., medical and pharmaceutical, agricultural, chemical, energetic and others. Nowadays hundreds of thousands of workers worldwide are employed in biotechnology plants. Health and safety issues related to such working activities are considered as relevant to workers as well as to the general public. In particular, when compared to traditional biotechnology, modern methods of processing microrganisms have given rise to public concern that they might generate hazards to human beings and to the environment. OBJECTIVES AND METHODS: After summarizing the most important products and fields of application, the paper sets out to detail potential adverse effects for the health of biotechnology workers; in addition, an analysis of the literature highlights the various concepts of primary and secondary prevention. RESULTS AND CONCLUSION: Along with occupational risk factors common to other working activities (i.e. the well-known physical and chemical hazards), the peculiarity of handling microrganisms and/or different biologic systems may induce infections, immunological alterations or non-infective and non-immunologic toxic reactions in the workers involved The need is emphasized for an accurate risk assessment, careful control by means of the current monitoring strategies and implementation of the confinement measures, taking into account the criteria set by Italian legislation for occupational biological risk. Lastly, attention is focussed on examinations for the medical surveillance of workers at risk.

Adult↗