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PubMed1996

Overview of therapeutic drug monitoring and biotechnologic drugs.

Therapeutic drug monitoring (TDM) is the science that combines measurement of serum drug concentrations with clinical pharmacokinetics. Biotechnological drugs may be obtained by recombinant DNA technology, monoclonal antibody technology, polymerase chain reaction, gene therapy, nucleotide blockade, peptide technology, and carbohydrate technology. Examples of biotechnological drugs include antisense drugs, clotting factors, hematopoietic factors, hormones, interferons, interleukins, monoclonal antibodies, tissue growth factors, and vaccines. For drugs that are physiological peptides used for substitution therapy, TDM is not indicated. For other biotechnological drugs, the criteria developed for monitoring of "classical" therapeutic agents should be used on an individual basis to determine whether there is a role for TDM.

Biotechnology↗
PubMed1989

Biotechnology policy and achievement 1980-88.

Much progress has been made in line with the spirit of Spinks, but it is inevitable that perspectives have changed since 1980. At the research level, we know that much strategic work remains to be done before the full industrial benefits of biotechnology can be secured, even though there has been a gratifying improvement in academic-industrial liaison. The industrial progress and dissemination of biotechnology has been slower than Spinks implied, but we have a clear understanding of the importance of such contributors to the climate for investment as balanced regulation, training and public perception. The international dimension is important not only for the potential benefit of research and development programmes but also to monitor progress in the U.K. with respect to our competitors. Biotechnology now finds itself in a new framework of Government policy for innovation; there are new challenges in sustaining and adding to the impetus built up by the academic and industrial communities.

Biotechnology↗
PubMed2000

Crop biotechnology. Where now?

Nature Biotechnology organized a conference in London on Agobiotech 99: Biotechnology and World Agriculture (November 14-16, 1999). The conference focused entirely on crop biotechnology and covered both societal and scientific aspects. Below is an account of the more important issues raised by the speakers and the audience.

Biotechnology↗
PubMed2005

Biotechnology applied to cultural heritage: biorestoration of frescoes using viable bacterial cells and enzymes.

AIMS: To set up and employ, for the biorestoration of cultural heritage (altered frescoes), an advanced and innovative biotechnology method based on the sequential use of whole viable bacterial cells and specific enzymes. METHODS AND RESULTS: The bioremediation intervention consisted of the direct application onto an artwork surface of whole bacterial cells of the Pseudomonas stutzeri A29 strain (bioaugmentation), followed by, in a final step, a purified Protease enzyme. The bioremediation was performed on a Spinello Aretino fresco that had become altered by the animal glue residues of past restoration. For the reader's interest the fresco is the 14th century Conversione di S. Efisio e battaglia (Conversion of S. Efisio and battle), size 3.5 x 7.8 m at the Pisa Camposanto Monumentale, Italy. An assessment was made of the final costs of the biological tests (whole bacterial cells, enzymes) so as to compare them with other intervention techniques. CONCLUSIONS: A successful innovative biological approach to recover valuable frescoes was set up, and the best conditions for treatment efficiency were identified. Furthermore the cost of the biological cleaning using viable bacterial cells and enzymes (P. stutzeri, Protease, Collagenase, 1 : 3 : 10, ratio respectively) was much lower than that of other conventional methods, making this biotechnology not only very interesting but also very competitive. SIGNIFICANCE AND IMPACT OF THE STUDY: New biotechnologies with an innovative, soft approach to the 'biocleaning' and 'biorestoration' of cultural heritage are in constant demand, and our results are clear evidence that such an approach has been achieved; the technique could be of significant importance towards developing other goals.

Adhesives↗
PubMed1989

Biotechnology and the Third World: development strategies in Cuba.

In March 1981, six researchers started production of natural interferon in a modest building adapted as a laboratory. By May the first yields of this protein were achieved. Applications of this interferon were already taking place in 1981 in the first clinical trial with the drug in the country. In June, the top level of the government decided to organize the Biological Group. In January, 1982, a new institution (CIB) began work with about 30 scientists and developed activities in gene manipulation, molecular virology, work with monoclonal antibodies, immunochemistry and tissue cultures. By 1983 interferon genes were cloned and expressed, and the group continued working, increasing the number of personnel. A decision was made in 1984 to build a new center, the CIGB. In July 1986, the center was officially inaugurated. Between 1986-89 important results were achieved by members of the biological group, among which was a vaccine against meningococcal meningitis. Three years later, in July 1989, the CIGB produced 15 new recombinant proteins, drugs, enzymes and antigens for diagnostic purposes. With the application of the most advanced technology, research has been conducted in areas such as gene regulation, bacterial and yeast genetics, protein structure and mammalian development. In addition, 43 types of monoclonal antibodies were produced as were 38 types of restriction enzymes (three of them recombinant), as well as several linkers, markers, and phages. Interferons, monoclonal antibodies, restriction enzymes, and epidermal growth factor, among others, are all being marketed. The CIGB became the leading institution in the country for work in modern biotechnology, generating new work styles in the country and developing a special selection procedure to include young scientists on the staff, simultaneously providing intense training in the center and abroad. This provided the stimulus of participating in the achievement of important results for the country, producing a positive feedback loop to maintain high standards. Interferon has been applied in more than 10,000 cases in the country. The diagnostic kit for AIDS based on recombinant proteins has been used in millions of tests and epidermal grow factor is already registered as a drug after fulfilling all the requirements of the preclinical and clinical testing with hundreds of patients in different clinical trials. A close connection with different institutions working in the field of biotechnology and with different universities has provided a greater strength for the work in modern biotechnology in Cuba.

Biotechnology↗
PubMed1989

Biotechnology and the Third World: the missing link between research and applications.

A United Nations University study investigated the activities of four major United Nations agencies that focussed on helping developing countries gain advanced capabilities in biotechnology. Relevant program and project documents were scrutinized at agency headquarters and managers were interviewed. Then, projects underway in three case countries (Egypt, Thailand, and Venezuela) were examined. The resulting information was used to assess whether United Nations projects were fulfilling these countries' needs and (or) advancing their capabilities in biotechnology. The minute, United Nations originated assistance available was directed solely at increasing capabilities in research and thus benefited bioscientists and their institutes. However, as virtually no linkage exists between the research establishment and the industrial--marketing sector, results from indigenous research does not reach industrialists or health workers. Consequently, biotechnology is neither advancing economic development in the case countries nor helping solve national problems. This situation is likely to persist because corrective systemic changes will be difficult to implement. Major implications of these findings are discussed, particularly as they bear on the United Nations system.

Academies and Institutes↗
PubMed2002

Perspectives on biotechnological applications of archaea.

Many archaea colonize extreme environments. They include hyperthermophiles, sulfur-metabolizing thermophiles, extreme halophiles and methanogens. Because extremophilic microorganisms have unusual properties, they are a potentially valuable resource in the development of novel biotechnological processes. Despite extensive research, however, there are few existing industrial applications of either archaeal biomass or archaeal enzymes. This review summarizes current knowledge about the biotechnological uses of archaea and archaeal enzymes with special attention to potential applications that are the subject of current experimental evaluation. Topics covered include cultivation methods, recent achievements in genomics, which are of key importance for the development of new biotechnological tools, and the application of wild-type biomasses, engineered microorganisms, enzymes and specific metabolites in particular bioprocesses of industrial interest.

Archaea↗
PubMed2005

Space, time and nature: exploring the public reception of biotechnology in New Zealand.

Nature is widely acknowledged to be a fluid, contested, material-semiotic construction, historically and spatially grounded. This is certainly the case for New Zealand, where a number of constructions of nature have been mobilized as a means to make judgements over the viability of particular biotechnologies that have entered into public debate. In this paper, we utilize Mikhail Bakhtin's space-time matrix, the chronotope, to explore a series of complementary nature-narratives that have been mobilized as a moral basis for making judgments over the acceptability of a series of exemplars of novel biotechnologies that were presented to participants in eleven national focus groups. We argue that it is the specific space-time manipulations that characterize these sometimes overlapping narrative constructions that are used to justify reactions to novel biotechnologies.

Biotechnology↗
PubMed2003

Safety assessment of foods produced through agricultural biotechnology.

Often the main criticism of foods derived from biotechnology is concerns about food safety. Whereas most present-day biotechnology-derived foods are approximately 99% similar to their non-biotechnology counterparts, the scientific community must ensure the safety of the novel aspects of these foods. The three phases of safety assessment are discussed and the concept of substantial equivalence is explained.

Agriculture↗
PubMed1995

Environmental safety assessment of vaccines derived from biotechnology.

Products derived from biotechnology are generally safer than previous products obtained by conventional, more empirical methods. Given the great variety of biotechnology-derived products and use situations, risk assessment procedures must be based on a case-by-case analysis. It is therefore difficult to propose a generic, well-defined risk assessment procedure. In the case of vectored vaccines, two main risks must clearly be assessed: the possible risk of tissue or species tropism modification, with special regard to non-target species, the risk of recombination with wild counterparts of the vector. This paper begins with a classification and description of the main biotechnology-derived products to be used in veterinary medicine, including deoxyribonucleic acid (DNA) vaccines, and then attempts to define general rules for the risk assessment of each category of products.

Animals↗
PubMed2000

Controlled delivery of biotechnological products.

Peptides, proteins, and nucleotides or DNA fragments are the new generation of drugs. They are becoming attractive owing to the fast development of biotechnology. The admnistration of such molecules, however, may be a problem as sensitivity to temperature, instability at some physiological pH values, short plasma half-life, and high molecular dimension, which hinders the diffusive transport, make, at the moment, parenteral route the only possible way of administration of such molecules. Controlled drug delivery that comprises the development of new administration routes could be the answer to the problems for administration of biotechnological molecules. The rational of drug delivery is to change the pharmacokinetic and pharmacodynamic of drugs by controlling their absorption and distribution. Rate and time of drug release at absorption site could be programmed using a so called delivery system. Different technologies, such as chemical (pro-drugs), biological, polymers, lipids (liposomes, LDL), have been proposed to obtain controlled drug release. Also the use of new administration routes is part of controlled drug delivery. In fact, it could increase the drug absorption and reduce the effects of the active ingredient in those districts not interested in the therapy. Drug delivery systems allowing for an effective release in vivo of new biotechnological molecules, such as recombinant antiidiotypic antibodies with antibiotic activity, devoted to the treatment of pulmonary (tuberculosis and pneumocystosis) and mucosal (candidiasis) diseases are discussed under that perspective.

Animals↗
PubMedDate not supplied

[Preclinical evaluation of the safety of biotechnology products: specific aspects].

Biotechnology-derived products represent a class of increasingly numerous drugs. One of their major characteristics is extreme diversity, which requires specific approaches for the preclinical evaluation of their safety. The selection of relevant animal species is not easy, as most of these products are human-specific. Thus, only one species will often be used, i.e. primates. As most of these products are large molecules, they can be directly immunogenic. When they are human-specific, no animal model is available to predict the risk. Many biotechnology-derived products have an expected influence on the immune system. This must be taken into account in the preclinical strategy of immunotoxicity evaluation that is now required for every new drug. As conventional toxicity testing is generally limited, safety pharmacology studies should include more than the core battery of assays required by current guidelines in order to complement missing data as much as possible. Because of these particularities, a comprehensive investigation of metabolism and pharmacokinetics is not usually needed. Some products can cross-react with cellular components not intended as therapeutic targets. It is, therefore, essential to rule out the risk of possible cross-reactions that can result in adverse effects. Finally, viral safety is a crucial component of the preclinical safety evaluation of these products. Overall, biotechnology-derived products raise specific issues because of their innovative and original characteristics, and it is difficult to address all these issues if not by using a case-by-case approach.

Animals↗
PubMed1987

The biotechnology of Bacillus thuringiensis.

One of the challenges in the application of biotechnology to pest control is the identification of agents found in nature which can be used effectively. Biotechnology offers the potential of developing pesticides based on such agents which will provide environmentally sound and economically feasible insect control alternatives. Such an agent, the insect pathogen Bacillus thuringiensis, is the subject of intense investigations in several laboratories. Insecticides which use the entomocidal properties of B. thuringiensis are currently produced and sold worldwide; new products are currently in the development stage. Herein, the biology and genetics of B. thuringiensis and the problems associated with current products are critically reviewed with respect to biotechnology. Moreover, the economic and regulatory implications of technologically advanced products are evaluated.

Amino Acid Sequence↗
PubMed1988

Nonconventional yeasts: their genetics and biotechnological applications.

To date, more than 500 species of yeasts have been described. Most of the genetic and biochemical studies have, however, been carried out with Saccharomyces cerevisiae. Although a considerable amount of knowledge has been accumulated on fundamental processes and biotechnological applications of this industrially important yeast, the large variety of other yeast genera and species may offer various advantages for experimental study as well as for product formation in biotechnology. The genetic investigation of these so-called unconventional yeasts is poorly developed and information about corresponding data is dispersed. It is the aim of this review to summarize and discuss the main results of genetic studies and biotechnological applications of unconventional yeasts and to serve as a guide for scientists who wish to enter this field or are interested in only some aspects of these yeasts.

Biotechnology↗
PubMed1989

Current biotechnological developments in Belgium.

In recent years, actions have been undertaken by the Belgian government to promote process innovation and technical diversification. Research programs are initiated and coordinated by the study committee for biotechnology setup within the Institute for Scientific Research in Industry and Agriculture (IRSIA). As a result of this action, the main areas where biotechnological processes are developed or commercially exploited include plant genetics, protein engineering, hybridoma technology, biopesticides, production by genetic engineering of vaccines and drugs, monoclonal detection of human and animal deseases, process reactors for aerobic and anaerobic wastewater treatment, and genetic modification of yeast and bacteria as a base for biomass and energy. Development research also includes new fermentation technologies principally based on immobilization of microorganisms, reactor design, and optimization of unit operations involved in downstream processing. Food, pharmaceutical, and chemical industries are involved in genetic engineering and biotechnology and each of these sectors is overviewed in this paper.

Agriculture↗
PubMed1994

The roles of magnesium in biotechnology.

This review highlights the important roles played by magnesium in the growth and metabolic functions of microbial and animal cells, and therefore assigns a key role for magnesium ions in biotechnology. The fundamental biochemical and physiological actions of magnesium as a regulatory cation are outlined. Such actions are deemed to be relevant in an applied sense, because Mg2+ availability in cell culture and fermentation media can dramatically influence growth and metabolism of cells. Manipulation of extracellular and intracellular magnesium ions can thus be envisaged as a relatively simplistic, but nevertheless versatile, means of physiological cell engineering. In addition, biological antagonism between calcium and magnesium at the molecular level may have profound consequences for the optimization of biotechnological processes that exploit cells. In fermentation, for example, it is argued that the efficiency of microbial conversion of substrate to product may be improved by altering Mg:Ca concentration ratios in industrial feedstocks in a way that makes more magnesium available to the cells. With particular respect to yeast-based biotechnologies, magnesium availability is seen as being crucially important in governing central pathways of carbohydrate catabolism, especially ethanolic fermentation. It is proposed that such influences of magnesium ions are expressed at the combined levels of key enzyme activation and cell membrane stabilization. The former ensures optimum flow of substrate to ethanol and the latter acts to protect yeasts from physical and chemical stress.

Animals↗
PubMed1996

Developments in biotechnological research in Austria.

Austria is a small European country with a small number of universities and biotechnological industries, but with great efforts in the implementation of environmental consciousness and corresponding legal standards. This review attempts to describe the biotechnological landscape of Austria, thereby focusing on the highlights in research by industry, universities, and research laboratories, as published during 1990 to early 1995. These will include microbial metabolite (organic acids, antibiotics) and biopolymer (polyhydroxibutyrate, S-layers) production; enzyme (cellulases, hemicellulases, ligninases) technology and biocatalysis; environmental biotechnology; plant breeding and plant protection; mammalian cell products; fermenter design; and bioprocess engineering.

Academies and Institutes↗
PubMed1997

Biotechnological aspects of membrane function.

An overview is given of the biotechnological utilizability of various features of cell membranes. Techniques are given that describe how to make use of the barrier and transport functions of membranes for biotechnological purposes, ranging from cell permeabilization and construction of immobilized biocatalysts to manipulating excretion and uptake properties of the membranes by various methods. Glucose transporters, iron-transporting membrane systems, and pumps engaged in pleiotropic drug resistance are treated in more detail as particularly biotechnologically important membrane proteins.

Biological Transport↗