Regulatory Practice for Biopharmaceutical Production / Edition 1

by Anthony S. Lubiniecki, Susan A. Vargo

Overview

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.

Product Details

ISBN-13:	9780471049005
Publisher:	Wiley
Publication date:	07/27/1994
Pages:	566
Product dimensions:	6.28(w) x 9.23(h) x 1.25(d)

About the Author

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

Table of Contents

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.

Editorial Reviews

Describes the regulatory aspects of pharmaceutical applications of novel biotechnology. The first two chapters furnish background on pharmaceutical regulations and biotechnology regulations. The rest of the work is divided into major sections that discuss the regulatory issues connected with biopharmaceutical processes, facilities, equipment, and products. Each plays a key interrelated role in the preparation of safe and effective protein agents. These relationships are examined and illustrated with specific product case histories. Not only are US regulatory views represented (from the perspective of both the regulator and the regulated), but also the European and Japanese views. Annotation c. Book News, Inc., Portland, OR (booknews.com)

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