ABSTRACT
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33.1 INTRODUCTION
Since 1982, when the first recombinant human insulin was licensed for therapeutic use, 50 additional pharmaceuticals and vaccines have been developed by biotechnology companies and approved by regulatory agencies. Advances in molecular biology, genomics, and proteomics, as well as innovations in pharmaceutical sciences have led to a rapid increase in the number of large-molecule pharmaceuticals for medical use. The human genome project has resulted in the identification of 30,000 human genes. The application of this new information to create new diagnostics, vaccines, and therapeutics holds great promise for the future of medical care. Biopharmaceuticals have revolutionized the prevention and treatment of diseases that currently are incurable or difficult to treat, such as cancer and cardiovascular, autoimmune, and genetic diseases; however, the complexity of the science and technology of biopharmaceuticals has resulted in challenges with regard to ensuring product quality, safety, and efficacy. In contrast to small-molecule drugs, which are chemically synthesized and whose structures are defined, biological products are derived from living sources, including humans, animals, plants, and microorganisms, using complicated manufacturing processes. These heterogeneous mixtures of large molecules are difficult to characterize, often display species specificity and various pharmacologic activities, are immunogenic, tend to be heat sensitive, and are susceptible to microbial contamination.
