PAT Applied in Biopharmaceutical Process Development And Manufacturing : An Enabling Tool for Quality-by-Design

Book Details

Format Hardback or Cased Book

Book Series Biotechnology and Bioprocessing

ISBN-10 1439829454

ISBN-13 9781439829455

Publisher Taylor & Francis Inc

Imprint CRC Press Inc

Country of Manufacture GB

Country of Publication GB

Publication Date Dec 7th, 2011

Print length 328 Pages

Weight 594 grams

Dimensions 16.20 x 24.20 x 2.30 cms

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Ksh 42,300.00

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"This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, especially in the area of real-time monitoring for end-point control as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends"--

This book summarizes the state of the art in process analytical technologies applied to various aspects of biopharmaceutical process development and manufacturing. The text summarizes regulatory perspectives, FDA/EMEA guidelines, and new expectations. In addition, it explores new technology, especially in the area of real-time monitoring for end-point control, as well as new sensor and analytical technologies. It details established and emerging measurement technologies, including future needs, and challenges that require further research. The authors also present successful industrial-scale deployment case studies and strategies from the biopharmaceutical industry and discuss future trends.

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