ABSTRACT

Biological drugs are macromolecular components of living systems used as drugs usually to treat natural deficiency states or in prophylaxis. Because of their macromolecular nature they are not amenable to synthesis in the laboratory and are obtained from extracts of cells, tissues, and organs. Almost all of the ªbiological drugsº currently in use are proteins and therefore the term ªbiological drugsº is used interchangeably with the term ªprotein drugsº. The greatest impact of biotechnology to date has been on the production of pharmaceutical proteins. This is because the earliest benefit to accrue from biotechnology was the capacity to produce proteins in large quantities. This chapter explores the advances in the production and use of protein therapeutics resulting from the application of biotechnology. Following a discussion of general principles, a few specific examples are considered. The production of chimeric proteins with novel activities, using gene splicing techniques, is also described.