Titlebook: Development and Manufacture of Protein Pharmaceuticals; Steve L. Nail,Michael J. Akers Book 2002 Springer Science+Business Media New York

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Quality Assurance and Quality Control for Biopharmaceutical Products,suring the consistency, quality, and safety of the manufactured drug product. Fortunately, many QA and QC systems are common to different manufacturing processes, such as chemical synthesis, isolation of biologies from natural sources, and production of biopharmaceuticals through recombinant DNA tec

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Regulatory Considerations in the Development of Protein Pharmaceuticals,and Drug Administration (FDA). It could be argued that biotechnology, as a discipline, was not new. Depending on the definition one selected, biotechnology could be considered as old as traditional beer- or bread-making, as indicated by one of the early definitions: “Biotechnology involves the appli

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Aseptic Processing of Protein Pharmaceuticals,amework for the development of aseptic processes at the lab bench, subsequent scale-up to clinical batches, and, finally, validation of the fully scaled-up and well-defined processes for commercial manufacturing of the drug product.

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Exploring Grouping Problems in Industryntrol, product testing, and auditing (see Table I). Application of these quality systems throughout the pharmaceutical industry is described in numerous reference books (Bryant, 1984; Peine, 1994; Sharp, 1991; Willig and Stoker, 1992).