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OverviewResearch 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. Full Product DetailsAuthor: Gail K Sofer , Lars-Erik Nystrom , L E E NystromPublisher: Academic Press Imprint: Academic Press ISBN: 9781322263786ISBN 10: 1322263787 Pages: 89 Publication Date: 01 January 2013 Audience: General/trade , General Format: Electronic book text Publisher's Status: Active Availability: In stock  We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately. Table of ContentsReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |
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