Edited by a world-renowned authority, with contributions from experts, this second edition explores the redefinition of the term biotechnology as applied to pharmaceuticals. The book examines the successful evolution of humanized monoclonal antibodies to treat rheumatoid arthritis and other diseases, considers the currently disappointing results of genetic engineering and genomics that have isolated disease-responsible genes without effect, and looks at the market and scientific reasons behind the failure of many biotechnology products to live up to their hype. It contains a discussion of regulatory and compendial issues and concludes with a look at future challenges facing biotechnology.
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Biopharmaceutics
Pharmaceutical Science
Reference
Professional

Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.
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Analysis & Pharmaceutical Quality
Pharmaceutical Manufacturing
Reference
Professional