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A recent addition.

Drug Identification Division

Biotechnology is broadly defined as: "the application of science and engineering to the direct and indirect use of living organisms or parts of organisms or products of organisms, in their natural or modified forms, for the production of goods or services."

To consolidate research activities at the Bureau of Drug Research in the area of biotechnology the bureau recently established a Biotechnology Section in the Drug Identification Division under the leadership of Larry W. Whitehouse. This section is responsible for developing a research programme in biotechnology as well as supporting a sister regulatory bureau, the Bureau of Biologics, with its safety and efficacy evaluations of novel drug products obtained through biotechnology.

The Biotechnology Section has a permanent staff of 11 professional and support personnel covering pharmacy, pharmaceutical chemistry, analytical chemistry, protein chemistry, pharmacology, cell biology, molecular biology, microbiology and toxicology. In addition to permanent staff, the section also employs individuals on post-doctoral, coop and cosep programmes.

The process of drug development requires that preclinical drug metabolism studies be performed in laboratory animals. The animal models are chosen according to physiological, anatomical and biochemical considerations. Despite the premise that only a mammalian system can be adequately predictive of human drug metabolism, as animal experiments become more expensive and as animal rights lobby groups become more influential, alternative testing models must be sought. The Biotechnology Section is currently devoting a significant proportion of its research activities to the development and use of in vitro mammalian cell culture and microbial systems to study drugs. Both animal and human cell culture techniques are being applied to the development of short-term cytotoxicity and carcinogenicity assays by Sabine H.H. Swierenga. In the laboratory of Brian C. Foster microbial systems are being exploited to study the metabolism and drug-drug interactions of drugs currently available for the treatment of AIDS patients. Particular emphasis is being placed on identifying treatment regimens which may be ineffective or deleterious because of interactions. Cultured microbial systems have proven useful also in converting novel compounds such as designer and illicit drugs obtained through police seizures, to products of pharmacological and/or toxicological interest, thus providing a much needed data base for these novel compounds.

Another area of research activity pursued by the Biotechnology Section relates to human carcinogenesis. While advances in therapeutic strategies have provided curative regimens for a number of cancers, these treatments are obtained at the price of considerable toxicity. Moreover, malignant tumors often behave unpredictably and different patients suffering from what appears to be the same disease show dramatically different responses to treatment. The development of new and successful strategies for the treatment of cancer will require an understanding of the genetic and biological basis for the diversity of behaviour manifested by the cells composing the tumour mass. Molecular genetic techniques are being applied to this area of research by Remy A. Aubin in an effort to identify genes and proteins which regulate the growth and spread of cancer cells. Once isolated these markers of malignant behaviour will be useful in the designing of treatment regimens more selective towards tumour cells. These markers will provide clinicians with new tools to facilitate early diagnosis, staging and grading of tumours, and the monitoring of the effects of drug treatment.

One of the underlying disciplines supporting our research areas is protein chemistry. Not only is it important to our current research endeavours but as drugs produced by novel biotechnological processes become more prevalent on the Canadian market, expertise in this area will be required to adequately regulate these new products. It is essential for safety and efficacy assessments that criteria for evaluation of product purity, stability and potency be established. Analytical methodologies employing high-pressure liquid chromatography, nuclear magnetic resonance, mass spectrometry and electrophoretic techniques for the assessment of product integrity are being developed by Michel Girard, MCIC. His current research is focused on the stability of polypeptide hormones and the characterization of macro-molecular protein-drug adducts.
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Title Annotation:Biotechnology Section of Canada's Bureau of Drug Research
Author:Whitehouse, Larry W.
Publication:Canadian Chemical News
Date:Nov 1, 1989
Words:656
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