Validating chromatographic methods : a p
โ David M Bliesner
๐ Library
๐
2006
๐ Wiley
๐ English
โฆ LIBER โฆ
๐
Process Chromatography. A Guide to Validation
โ Scribed by Gail K. Sofer and L. E.E. Nystrom (Auth.)
- Publisher
- Academic Press
- Year
- 1991
- Tongue
- English
- Leaves
- 81
- Edition
- 1st
- Category
- Library
โฌ Acquire This Volume
No coin nor oath required. For personal study only.
โฆ 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
โฆ Table of Contents
Content:
ACKNOWLEDGEMENTS, Page ii
Front Matter, Page iii
Copyright, Page iv
Preface, Page vii
1 - Introduction, Pages 1-4
2 - Process Design, Pages 5-30
3 - Process Qualification and Validation, Pages 31-59
4 - Analytical Techniques in Validation, Pages 61-64
5 - Case Studies and Product Changeover, Pages 65-69
6 - Conclusion, Pages 71-72
Appendix - Regulatory terms and abbreviations, Pages 73-75
Index, Pages 77-80
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