ABSTRACT
Nowhere in the development of emerging industries does quality control play as important a role as in Biotechnology (1). The uniqueness of this industry is based on the use of genetically altered living organisms for the manufacture of commercial and human health care products. Although it traces its origins to the fermentation industry, Biotechnology is best represented by the recombinant DNA (rDNA) and monoclonal antibody industries. Only a decade old, these industries have succeeded in developing a number of products that profoundly affect the quality of human life. An example of a product derived from rDNA technology is the recently approved thrombolytic therapy drug, human tissue-type plasminogen activator (rt-PA) (2). A highly specific enzyme, rt-PA converts plasminogen to plasmin, the active fibrinolytic enzyme that dissolves blood clots causing certain myocardial infarctions.
