Introduction to Biopharmaceuticals

Using the broadest definitions, a biopharmaceutical may be defined as any molecule intended for therapeutic, prophylactic or diagnostic use that was generated by a manufacturing process incorporating the use of living cells. This definition applies even if the therapeutic entity is thought to be identical in molecular structure to a naturally occurring substance. The most common biopharmaceuticals to date are proteins derived from recombinant DNA technologies and monoclonal antibodies resulting...

Development and Validation of Analytical Methods

Analytical Research and Development DuPont Merck Pharmaceutical Company Wilmington, DE 19880, USA and Department of Pharmaceutical Chemistry University of Kansas, Lawrence, KS 66045, USA Analytical Chemistry Department Hoechst Marion Roussel, Inc., Kansas City, MO 64134, USA U.K. Elsevier Science Ltd, The Boulevard, Langford Lane, Kidlington, Oxford 0X5 1GB, U.K. U.S.A. Elsevier Science Inc., 660 White Plains Road, Tarrytown, New York 10591-5153, U.S.A. JAPAN Elsevier Science Japan, Tsunashima...