Process Chromatography
：A Guide to Validation
Publication subTitle ：A Guide to Validation
Author： Sofer Gail K.;Nystrom L. E. E.
Publisher： Elsevier Science
Publication year： 2015
E-ISBN: 9781483289175
P-ISBN(Paperback): 9780126542677
Subject： O657.7 chromatographic analysis
Keyword： 化学
Language： ENG
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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.