Description

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.

Readership

Biotechnologists, molecular biologists, and those working in the pharmaceutical industry on biologicals/therapeutics.

Table of Contents

Process Design. Process Qualification and Validation. Analytical Techniques in Validation. Case Studies. Process Changeover. Conclusion. Appendix: Regulatory Terms and Abbreviations.

Details

No. of pages:
96
Language:
English
Copyright:
© 1991
Published:
Imprint:
Academic Press
Electronic ISBN:
9781483289175
Print ISBN:
9780126542677

About the authors

Gail Sofer

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.