The traditional role of the pharmaceutical industry, i.e. synthesis of new chemical entities as therapeutic agents, was suddenly expanded by the introduction of the first biotechnologically derived products in the 1980s. The approval of recombinant human insulin in 1982 broke important ground for products produced by genetic engineering (19). In 1985 another milestone was achieved when Genentech became the first biotechnology company to be granted approval to market a recombinant product, human growth hormone. These events set an entire industry into motion, to produce not only natural proteins for the treatment of deficiency-associated diseases, but also true therapeutics for both acute and chronic care.
Industry estimates show the upward trend in biotechnologicallyderived drugs continuing into the new millennium. Over 400 products generated by biotechnology are estimated to be somewhere in the development pipeline or approval process. A comprehensive list of FDA approved biotechnology drugs is available on the web at www.bio.org/er/approveddrugs. asp. The variety of products—from hormones and enzymes to receptors, vaccines, and monoclonal antibodies—seeks to treat a broad
range of clinical indications thought unbeatable just two decades ago. However, despite this period of phenomenal growth for recombinant DNA-derived therapeutics, the promise of biotechnology, once touted to be limitless, has instead become more realistically defined to include not only the actual recombinant products and the difficulties inherent in their production but also many spin-off technologies, including diagnostics and genetically defined drug discovery tools (20-22).
One particular area of traditional pharmaceutical research in which recombinant DNA technology has made a profound impact has been the engineering of antibiotic-producing organisms (23-25). Always an important source of new bioactive compounds, especially antibiotics (26, 27), fermentation procedures can be directly improved by strain optimization techniques, including genetic recombination and cloning. More exciting is the possibility of producing hybrid antibiotics that combine desirable features of one or more individual compounds for improved potency, bioavailability, or specificity. The art of finding new natural product-based lead compounds by screening fermentation broths, plant sources, and marine organisms by using genetically engineered reagents is becoming of special importance as more of the relevant targets identified by molecular biology operate in obscure or even unknown modes. The structural diversity provided by natural products combined with the ability to test molecular biology driven biochemical hypotheses has already become an important route for the discovery of new therapeutics (28-30).
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