Quality Assurance for Biopharmaceuticals

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This volume provides basic guidelines concerning quality assurance and its responsibilities for biopharmaceuticals manufactured by either recombinant, monoclonal antibody or other biotechnological methodologies. The author discusses what systems are needed, and gives a detailed description of each system and its functions. Leading authorities in the biotechnology industry offer insight and suggestions in order to assure the safety, purity and efficacy of the products produced.