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PubMed1993

The development of property rights in biotechnology.

The translation of biological theory into engineering (biotechnology) has resulted in the development of novel products and processes. Some of these products are living organisms, usually containing unique genetic arrangements not found in nature. The extension of legal protection to products and processes was required in order for biotechnology to become an unexceptional way in which to do business. The American experience with biotechnology, repeated elsewhere, is demonstrated to have proceeded first through the negotiation of obstacles in administrative law and second through challenges to property law. This outcome for the regulatory management of biotechnology and the legal protection of its products may be interpreted as a function of a cultural bias for scientific authority and progress ideology.

Biotechnology↗
PubMed2002

Diatom cultivation and biotechnologically relevant products. Part II: current and putative products.

While diatoms are widely present in terms of diversity and abundance in nature, few species are currently used for biotechnologically applications. Most studies have focussed on intracellularly synthesised eicosapentaenoic acid (EPA), a polyunsaturated fatty acid (PUFA) used for pharmaceutical applications. Applications for other intracellular molecules, such as total lipids for biodiesel, amino acids for cosmetic, antibiotics and antiproliferative agents, are at the early stage of development. In addition, the active principle component must be identified amongst the many compounds of biotechnological interest. Biomass from diatom culture may be applied to: (1). aquaculture diets, due to the lipid- and amino-acid-rich cell contents of these microorganisms, and (2). the treatment of water contaminated by phosphorus and nitrogen in aquaculture effluent, or heavy metal (bioremediation). The most original application of microalgal biomass, and specifically diatoms, is the use of silicon derived from frustules in nanotechnology. The competitiveness of biotechnologically relevant products from diatoms will depend on their cost of production. Apart from EPA, which is less expensive when obtained from Phaeodactylum tricornutum than from cod liver, comparative economic studies of other diatom-derived products as well as optimisation of culture conditions are needed. Extraction of intracellular metabolites should be also optimised to reduce production costs, as has already been shown for EPA. Using cell immobilisation techniques, benthic diatoms can be cultivated more efficiently allowing new, biotechnologically relevant products to be investigated.

Amino Acids↗
PubMedDate not supplied

Opening remarks SIVB congress 2001: opportunities and challenges in plant biotechnology.

U.S. Senator Christopher Bond joined Dr. Roger Beachy at the podium during the Society for In Vitro Biology's 2001 Congress Plenary Session on Opportunities and Challenges in Plant Biotechnology to Benefit Health and Sustainability, on June 17, 2001, in St. Louis, Missouri. Senator Bond presented an advocate's view regarding the benefits of plant biotechnology development. The strengths of the biotechnology regulatory system were extolled. The opportunities of this new technology to produce more and nutritionally superior food, additional plant-based medicines and vaccines, plant-based renewable sources of energy, and renewable industrial products were outlined. The benefits to the environment by adopting plant biotechnological innovations were discussed. Developing public policy regarding this new technology should be based on facts, science, and reason.

Biotechnology↗
PubMed2004

How Japanese students reason about agricultural biotechnology.

Many have claimed that education of the ethical issues raised by biotechnology is essential in universities, but there is little knowledge of its effectiveness. The focus of this paper is to investigate how university students assess the information given in class to make their own value judgments and decisions relating to issues of agricultural biotechnology, especially over genetically modified organisms (GMOs). Analysis of homework reports related with agricultural biotechnology after identification of key concepts and ideas in each student report is presented. The ideas were sorted into different categories. The ideas were compared with those in the reading materials using the same categories. These categories included: concern about affects on humans, affects on the environment, developing countries and starvation, trust in industry, responsibility of scientists, risk perception, media influence, need for (international) organizations or third parties, and information dissemination. What was consistent through the different years was that more than half of the students took a "neutral" position. A report was scored as "neutral" when the report included both the positive and negative side of an issue, or when the student could not make a definite decision about the use of GMOs and GM food. While it may be more difficult to defend a strong ''for" or "against" position, some students used logical arguments successfully in doing so. Sample comments are presented to depict how Japanese students see agricultural technology, and how they value its application, with comparisons to the general social attitudes towards biotechnology.

Agriculture↗
PubMed1992

Separation techniques for biotechnology in the 1990s.

Scientists are constantly looking for better and cheaper separation techniques to replace or complement the current technology. Over the past few decades, and in particular the last 10 years, new separation techniques or modifications of existing techniques have become available for separating compounds from complex sample matrices. There are many areas, however, where the separation technology is not sufficient to achieve high purity and yield while remaining cost effective. In the area of biotechnology, separation techniques are urgently needed to meet demands for ultra-high purity and yield. Thus, a variety of techniques are being developed to address these needs. Generally, biological compounds for the pharmaceutical and biotechnology industries must be obtained at greater than 99.9% purity (sometimes greater than 99.99%) while maintaining high yield. In any area of chemistry this degree of purity would cause problems; in biotechnology it is even more difficult to achieve because of the complex sample matrices. In addition, the compounds of interest may be very similar to impurities or contaminants in the sample matrix, and the compounds could be denatured (or even destroyed) by certain solvents and/or high temperature. In particular, three areas of biotechnology have presented scientists with problems in separations: cell separations, DNA-RNA separations, and protein-peptide separations. The current technology available and possible future trends in these areas are discussed, and also problems to be solved in the future.

Base Sequence↗
PubMed2006

A review on reproductive biotechnologies for conservation of endangered mammalian species.

This review describes the use of modern reproductive biotechnologies or assisted reproductive techniques (ART) including artificial insemination, embryo transfer/sexing, in vitro fertilization, gamete/embryo micromanipulation, semen sexing, genome resource banking, and somatic cell nuclear transfer (cloning) in conservation programs for endangered mammalian species. Such biotechnologies allow more offspring to be obtained from selected parents to ensure genetic diversity and may reduce the interval between generations. However, the application of reproductive biotechnologies for endangered free-living mammals is rarer than for endangered domestic breeds. Progress in ART for non-domestic species will continue at a slow pace due to limited resources, but also because the management and conservation of endangered species is biologically quite complex. In practice, current reproductive biotechnologies are species-specific or inefficient for many endangered animals because of insufficient knowledge on basic reproduction like estrous cycle, seasonality, structural anatomy, gamete physiology and site for semen deposition or embryo transfer of non-domestic species.

Animals↗
PubMed2005

Biotechnology-a sustainable alternative for chemical industry.

This review outlines the current and emerging applications of biotechnology, particularly in the production and processing of chemicals, for sustainable development. Biotechnology is "the application of scientific and engineering principles to the processing of materials by biological agents". Some of the defining technologies of modern biotechnology include genetic engineering; culture of recombinant microorganisms, cells of animals and plants; metabolic engineering; hybridoma technology; bioelectronics; nanobiotechnology; protein engineering; transgenic animals and plants; tissue and organ engineering; immunological assays; genomics and proteomics; bioseparations and bioreactor technologies. Environmental and economic benefits that biotechnology can offer in manufacturing, monitoring and waste management are highlighted. These benefits include the following: greatly reduced dependence on nonrenewable fuels and other resources; reduced potential for pollution of industrial processes and products; ability to safely destroy accumulated pollutants for remediation of the environment; improved economics of production; and sustainable production of existing and novel products.

Biotechnology↗
PubMed2006

Patho-biotechnology: using bad bugs to do good things.

Pathogenic bacteria have evolved sophisticated strategies to overcome host defences, to interact with the immune system and to interfere with essential host systems. We coin the term 'patho-biotechnology' to describe the exploitation of these valuable traits in biotechnology, medicine and food. This approach shows promise for the development of novel vaccine and drug delivery systems, as well as for the design of more technologically robust and effective probiotic cultures with improved biotechnological and clinical applications. The genetic tractability of Listeria monocytogenes, the availability of the complete genome sequence of this intracellular pathogen, its ability to cope with stress, and its ability to traverse the gastrointestinal tract and induce a strong cellular immune response make L. monocytogenes an ideal model organism for demonstrating the patho-biotechnology concept.

Animals↗
PubMed2002

The legacy of nuclear risk and the founder effect in biotechnology organizations.

In the wake of the Chernobyl nuclear accident and a decline in the public trust of science, the founders of modern biotechnology recognized the strategic importance of risk assessment and regulatory affairs. In an effort to avoid the demonization that was attached to the nuclear industry, the pioneers of modern biotechnology delegated authority for regulatory negotiation and risk management to senior positions in the firm. At the same time, the Biotechnology Industry Organization was handed great latitude and trust with making public pronouncements on issues of bioethics and public policy. The way in which founders and leaders embed norms for negotiating regulation and responding to public perceptions has proved important in the maturation and acceptance of a biotechnology sector.

Biotechnology↗
PubMed2002

Advanced agricultural biotechnologies and sustainable agriculture.

Agricultural biotechnologies are anchored to a scientific paradigm rooted in experimental biology, whereas sustainable agriculture rests on a biological paradigm that is best described as ecological. Both biotechnology and sustainable agriculture are associated with particular social science paradigms: biotechnology has its foundation in neoclassical economics, but sustainability is framed by an emerging community-centered, problem-solving perspective. Fundamentally, biotechnology and neoclassical economics are reductionist in nature. Sustainability and community problem-solving, however, are nonreductionist. Given these differences, we might see the development of two rather distinct systems of food production in the near future.

Agriculture↗
PubMed1999

Assessment of biotechnology drugs: what are the issues?

Biotechnology is increasingly regarded as an important reservoir for the development of new and innovative, but generally expensive, pharmaceuticals. At the same time, concerns about cost containment have triggered a keen interest in evaluating and comparing the values of diverse health care interventions. In this paper we studied the process of assessment and diffusion of biotechnology drugs by studying three cases, i.e. nebacumab, colony stimulating factors and recombinant human growth hormone. These cases are evaluated in a standardised format, concerning safety, efficacy, cost-effectiveness and ethical, legal and social issues. Many factors that determine the fate of a biotechnology drug seemed to be similar to those of 'classical' drugs. The definition and measurement of clinically relevant outcomes has been identified as a key factor in the assessment process. Another important issue is the relatively small population for the primary indications of biotechnology drugs and the subsequent process of broadening of indications. Paradoxically, the current trend towards evidence-based medicine means that we will increasingly have to make decisions based on 'incomplete' knowledge'.

Antibodies, Monoclonal↗
PubMed2001

Agricultural biotechnology in developing countries.

After a slow start many developing countries are now investing in agricultural biotechnology. Although these countries face several constraints, efforts are being made to promote biotechnology that requires high investment with long term returns. A number of donor agencies are providing incentives to stimulate biotechnology in the developing countries. There is however a major debate towards the development of biotechnology, especially genetically modified organisms, in the developing countries and there is a need for them to address biosafety issues and proper monitoring systems. The concern of intellectual property rights is a major issue in the developing countries in order to have access to the technologies that are often owned by multinational corporations in the industrialized countries.

Agriculture↗
PubMed2003

Realizing the promises of marine biotechnology.

High-quality research in the field of marine biotechnology is one of the key-factors for successful innovation in exploiting the vast diversity of marine life. However, fascinating scientific research with promising results and claims on promising potential applications (e.g. for pharmaceuticals, nutritional supplements, (feed-)products for aquaculture and bioremediation solutions) is not the only factor to realise the commercial applications of marine biotechnology. What else is needed to exploit the promising potential of marine biotechnology and to create new industrial possibilities? In the study project 'Ocean Farming-Sustainable exploitation of marine organisms', we explore the possibilities of marine organisms to fulfill needs, such as safe and healthy food, industrial (raw) materials and renewable energy in a sustainable way. One of the three design groups is envisioning the future of strong land-based 'marine' market chains. Marine biotechnology is one of the foci of attention in this design group. This article provides a model of future-oriented thinking in which a variety of experts actively participate.

Aquaculture↗
PubMed2003

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.

Biological Factors↗
PubMed2003

Guidelines for analytical method development and validation of biotechnological synthesis of drugs. Production of a hydroxyprogesterone as model.

In connection with biotechnological synthesis of pharmaceutical drugs, validated methods for quantification of both product and substrate at different time intervals are essential for proper calculation of rate coefficients. In this field, there still exist no guidelines for analytical validation, unlike the situation in the bioanalytical field. Therefore, in this study the detailed guidelines by FDA for bioanalytical method validation were applied to a typical biotechnological process; the enzymatic synthesis of 9alpha-hydroxyprogesterone in E. coli using progesterone as substrate. The process liquid was extracted and analyzed using an HPLC-DAD system. The quality control (QC) samples of the product demonstrated excellent precision (C.V.<1.5%) and accuracy between 99.3 and 107%. The study showed that the recommendations and the validation terms for bioanalytical methods can be used also for biotechnological production, but with some important exceptions. The tolerances (C.V. values) of the validation terms should be much narrower; the internal standard (I.S.) must be present in the process liquid before the start of the process and must be much different in structure from the substrate (so as not to participate in the biotechnological process). In addition, the selectivity must be checked very frequently during the process due to the changes in the blank process liquid with time.

Biotechnology↗
PubMed2000

Varieties of secrets and secret varieties: the case of biotechnology.

This article examines several trends that have combined to veil the new field of biotechnology in secrecy: the transformation of biotechnology from an essentially academic field characterized by strong norms of openness to a field with extensive corporate connections that have reached even to research in leading universities; the establishment of intellectual property rights for life-forms initiated by the landmark Supreme Court decision, Diamond v. Chakrabarty; and the limiting of public access to information about the genetically altered organisms whose use in agriculture, industry, and medicine falls under government controls. The article also examines the effects of the U.S. biotechnology industry's demand for secrecy on the negotiations for a protocol to the 1972 Biological Weapons Convention, particularly the turn from requirements for transparency to protection of opacity with respect to biotechnology and other biological processes, equipment, and production.

Access to Information↗
PubMed2002

Top ten biotechnologies for improving health in developing countries.

Most research into genomics and other related biotechnologies is concerned with the priorities of industrialized nations, and yet a limited number of projects have shown that these technologies could help improve health in developing countries. To encourage the successful application of biotechnology to global health, we carried out a study in which we asked an international group of eminent scientists with expertise in global health issues to identify the top ten biotechnologies for improving health in developing countries. The results offer concrete guidance to those in a position to influence the direction of research and development, and challenge common assumptions about the relevance and affordability of biotechnology for developing countries.

Biotechnology↗
PubMed2002

The application of biotechnology to nutrition: an overview.

Crop biotechnology is being used in two major ways to enhance human nutrition: to improve global food security by making more food available, especially locally grown and familiar foods in the developing world, and by enhancing the nutritional composition of foods that would interest both the developed and developing worlds. Since the first commercialized products of biotechnology are major commodity crops grown primarily in the US, Canada and Argentina (soybeans, corn, canola and cotton), there is concern about whether and when crop biotechnology will help the developing world. There are, however, several on-going projects in Africa, SE Asia and Latin America where crop biotechnology is being used to enhance locally grown crops. The expectation is that genetically improved crops, e.g., those able to resist local pests, will allow even small-scale farmers to grow more crops using fewer inputs and in an environmentally sustainable manner. Furthermore, there are numerous on-going projects to enhance the nutritional or health value of foods via transgene technology. A few of these projects are described in this article.

Biotechnology↗