ABSTRACT
Pharmaceutical biotechnology and the products resulting for biotechnologies continue to grow at an exponential rate. Note that 2005 was a record setting year with the U.S. Food and Drug Administration (FDA) approval of 21 biopharmaceutical products. There were 15 FDA approvals in 2004, 20 in 2003, and 13 in 2002 since the last edition of this textbook (Rader 2006; Staff, 2006). Early 2006 saw approvals of several unique new biopharmaceutical entities including a recombinant vaccine widely hailed as the first vaccine for the prevention of an oncogenic virus-associated cancer. However, until recently, the techniques made available by advances in molecular biology and biotechnology that have provided currently approved therapeutic agents generally fell into two broad areas: recombinant DNA (rDNA) technology and hybridoma techniques (to produce monoclonal antibodies). The technology that is fueling our ever-widening understanding of human cellular function and disease processes is undergoing an explosive evolution. Awealth of additional and innovative biotechnologies, have been, and will continue to be, developed in order
to harvest the information found in the humangenome. These technological advances will provide a better understanding of the relationship between genetics and biological function, unravel the underlying causes of disease, explore the association of genomic variation and drug response, enhance pharmaceutical research, and fuel the discovery and development of new and novel biopharmaceuticals. These revolutionary technologies and additional biotechnology-related techniques are improving the very competitive and costly process of drug development of newmedicinal agents, diagnostics and medical devices. Some of the technologies and techniques described in this chapter are both well established and commonly used applications of biotechnology producing potential therapeutic products now in development including clinical trials. Still more applications are evolving as you read this text. Their full impact on the future of molecular medicine has yet to be imagined.
