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.

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