Regulatory Practice for Biopharmaceutical Production

Herausgeber: Lubiniecki, Anthony S; Vargo, Susan A

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: Wiley
• Seitenzahl: 566
• Erscheinungstermin: 27. Juli 1994
• Englisch
• Abmessung: 235mm x 157mm x 38mm
• Gewicht: 1064g
• ISBN-13: 9780471049005
• ISBN-10: 047104900X
• Artikelnr.: 22474136

Autorenporträt

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

Inhaltsangabe

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.