Regulatory Practice for Biopharmaceutical Production

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.

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 BVaccine Produced by Recombinant Technology (A. Elliott, etal.). 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.