PAT applied in biopharmaceutical process development and manufacturing
an enabling tool for quality-by-design
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Word Count
74,750 words, Guess
Page Count
299 pages
Identifiers
- Open LibraryOL25177211M
- ISBN-139781439829455
- OCLC Control Number775569804
- OCLC Control Number746489188
- Library of Congress Control Number2011031862
Classifications
- DDC615.1/9
- LCCRS380 .P37 2012
Description
"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"--
Subjects
Topics
Series Statement
- Biotechnology and bioprocessing series
Other Editions
- PAT applied in biopharmaceutical process development and manufacturing: an enabling tool for quality-by-design
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