Process Chromatography: A Guide to Validation - Hardcover

Sofer, Gail K.; Nystrom, L. E.E.

Hardcover

ISBN 10: 0126542678 ISBN 13: 9780126542677

Publisher: Academic Press, 1991

Synopsis

Research and development into biological products for therapeutic use has increased dramatically over the last 10 years. With this, strict regulatory requirements have been imposed by authorities such as the U.S. Food & Drug Administration, so that today validation has become a key issue in the biopharmaceutical industry.
This concise book addresses validation issues in the chromatography of biotherapeutics. It covers process design, qualification and validation, including an overview of analytical techniques commonly used in the validation of processes. A concluding section comments on product changeover and presents four case studies.

About this title

About the Author:

Gail Sofer has been consulting with biotechnology and pharmaceutical companies for the past five years through the Fast Trak Validation(r) group of PharmaciaBiotech as the Director of International Validation Development. A series of publications on validation have provided guidance to many in this arena. She is active in organizations such as PDA and ASTM.

About this edition

• Publisher: Academic Press
• Publication date: 1991
• ISBN 10: 0126542678
• ISBN 13: 9780126542677
• Binding: Hardcover
• Edition number: 1
• Number of pages: 96