Regulatory Practice for Biopharmaceutical Production
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More About This Title Regulatory Practice for Biopharmaceutical Production
English
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.
English
Anthony S. Lubiniecki and Susan A. Vargo are the authors of Regulatory Practice for Biopharmaceutical Production, published by Wiley.
English
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.
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.
