Description
Book SynopsisProvides an overview of controversial regulatory issues in biotechnology, covering fundamental aspects, specific products and international perspectives. The licensing concerns critical to facility design and product manufacturing are discussed in detail.
Table of ContentsPartial 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.
