This Handbook describes the use of biotechnology to develop pharmaceuticals. The process of biotechnological drug development systematically identifies which protein is causing a problem in the body either because it is absent, defective, or excessive and then identifying and engineering a protein or related molecule to correct the problem. The Handbook of Pharmaceutical Biotechnology gives the professional a basic tool to facilitate the development of biotech medicines by bringing together, in one resource, a general but, not trivial, overview of biotechnology used in the drug development process, along with a compendium of regulations and validation methods that need to be considered when using biotech to develop a new drug.