Titlebook: Antibodies; Volume 1: Production G. Subramanian Book 2004 Springer Science+Business Media New York 2004 HIV.cancer.cancer therapy.developme

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Concepts in Development of Manufacturing Strategies for Monoclonal Antibodies, creating an immortal antibody producing cell, a hybridoma (Kohler and Milstein, 1975). Since the first mouse monoclonal antibodies were produced, the idea of using them as therapeutics or “magic bullets” has been viewed as major exploitation of this technology. This is, in part, due to the fact tha

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Antibody Fragments,scular and infectious diseases. This is largely due to the development of technologies that enable the generation of antibodies of high specificity and low immunogenicity with relative ease (Maynard and Georgiou, 2000). The specificity of all antibodies is determined by the nature of their binding t

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Large-Scale Production of Therapeutic Antibodies: Considerations for Optimizing Product Capture andlin, most of the initial wave of biotechnology products launched in the 1980s and 1990s were peptide hormones and enzymes licensed for indications with relatively small patient populations and for short-term rather than chronic use. Consequently, the market requirement for these products was frequen

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Quality Control of Antibodies for Human Use,international regulatory authorities. The US Food and Drug Administration (FDA) issued a guidance in 1997 specifically for antibody products in its “Points to consider in the manufacture and testing of monoclonal antibody products for human use”. This guideline describes the quality control for the

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