Wiley-VCH - Lubiniecki, Anthony S. / Vargo, Susan A. (eds.) - Regulatory Practice for Biopharmaceutical Production

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Ernst & Sohn

Lubiniecki, Anthony S. / Vargo, Susan A. (eds.) Regulatory Practice for Biopharmaceutical Production August 1994 302.- Euro 1994. 566 Pages, Hardcover ISBN 978-0-471-04900-5 - John Wiley & Sons
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Detailed description Biotechnology represents a novel and expanding international industry bound by new and ever-changing legislature. This text provides a comprehensive overview of product-specific, international and country-specific licensing requirements and general regulatory issues in biotechnology. From the contents Partial table of contents: A U.S. View of New Biotechnology Regulation (H. Miller). Genetic Stability of Host Cell and Product (M. Wiebe & N. Lin). Quality Control Issues for the New Biotechnology (S. Vargo). Strategic Decisions in Process Design (A. Lubiniecki). Experience in Manufacturing, Testing, and Licensing a Hepatitis B Vaccine Produced by Recombinant Technology (A. Elliott, et al.). Tissue Plasminogen Activator: Regulatory Issues (D. Beebe & G. Murano). Recombinant Peptide Hormones (Y.-y. Chiu). Cytokine and Growth Factor Products (L. Dujack & K. Zoon). Licensing Biotechnology Facilities (R. Devine). Computerized Systems Validation (R. Branning). Regulation of Pharmaceuticals in Japan (M. Dibner). Unresolved Issues (T. Copmann & J. Petricciani). Index.

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