Biotechnology pharmaceuticals hormone

Mulders, J.W.M., Wijn, H., and Theunissen, F. Development and validation of a capillary zone electrophoresis method which can be used to predict the in-vivo bioactivity of recombinant folh-cle stimulating hormone, in Proceedings of the 3rd Symposium on the Analysis of Well Characterized Biotechnology Pharmaceuticals (WCBP), Washington, DC, 1999. 

In addition to chemical-based drugs, a range of pharmaceutical substances (e.g. hormones and blood products) are produced by/extracted from biological sources. Such products, some major examples of which are listed in Table 1.2, may thus be described as products of biotechnology. In some instances, categorizing pharmaceuticals as products of biotechnology or chemical synthesis becomes somewhat artificial. For example, certain semi-synthetic antibiotics are produced by chemical modification of natural antibiotics produced by fermentation technology. 

Biotechnology-derived pharmaceuticals (biopharmaceuticals) appeared for the first time in the 1980s for medical treatment of diseases, such as diabetes mellitus and hypophysical dwarfism. Since then the number and types of biopharmaceuticals have climbed and continue to dramatically increase. One reason for the increase is the evolution of recombinant manufacturing of biopharmaceuticals. This has provided sufficient amounts of proteins for development and clinical use, whereas, for example, the amount of insulin or growth hormones extracted from animal or human tissues had been limited. Another... 

Ideally, the pharmaceutical should consist of the pure active isomer. One way to obtain the compound as a pure active isomer is to produce the chemical by using organisms, because the production of biomolecules in organisms is stereospecific (yields a specific stereoisomer). For example, amino acids, vitamins, and hormones are naturally produced by yeast in the fermentation of sugar and can be harvested from the ferment. Biotechnology, in which the gene for a particular molecule is inserted into the DNA of a bacterium, provides another approach. Insulin is now produced in this way. 

Recent reviews Hst more than 400 biotechnology-based pharmaceutical formulations either registered in clinical trials or undergoing review by the regulatory agencies for the treatment of nearly 150 diseases including cancer, infectious diseases, autoimmune diseases, and AIDS/HIV (1,2). Biotechnology-based pharmaceuticals already on the markets include recombinant blood factors, recombinant hormones, cytokines, vaccines, monoclonal antibody-based products, and therapeutic enzymes. 

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