Filtration and Purification in the Biopharmaceutical Industry

2nd Edition

Maik J. Jornitz, Maik W. Jornitz, Theodore H. Meltzer

CRC Press
Published November 28, 2007
Reference - 816 Pages - 314 B/W Illustrations
ISBN 9780849379536 - CAT# DK7953
Series: Drugs and the Pharmaceutical Sciences

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Summary

Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, including the current methods, processes, technologies and equipment, and brings you up-to-date with the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.

An essential, comprehensive, source for all professionals involved with filtration and purification practices and compliance, this text

·        addresses recent biotechnology-related processes and advanced technologies, such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and medium and buffer filtration

·        presents detailed updates on the latest FDA and EMEA regulatory requirements involving filtration and purification practices

·        describes current industry quality standards and validation requirements and provides guidance for compliance

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