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.

Spis treści:
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.