PAT applied in biopharmaceutical process development and manufacturing : an enabling tool for quality-by-design / edited by Cenk Undey [and others].

"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, e...

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Bibliographic Details
Other Authors: Undey, Cenk
Format: eBook
Language:English
Published: Boca Raton, Fla. : CRC Press, ©2012.
Series:Biotechnology and bioprocessing series ; 33.
Subjects:
Online Access:Click for online access
Description
Summary:"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."
Physical Description:1 online resource.
Bibliography:Includes bibliographical references and index.
ISBN:9781439829462
1439829462
128012184X
9781280121845