PAT applied in biopharmaceutical process development and manufacturing
Subtitle: an enabling tool for quality-by-design
By: edited by Cenk Undey... [et al.].
Series: Biotechnology and bioprocessing series
Publisher: CRC Press
Published: 2012
Place of publication: Boca Raton, FL
Language: eng
Number of pages: 299
ISBN-13: 9781439829455
Subjects: Biopharmaceutics; SCIENCE / Biotechnology; SCIENCE / Chemistry / Analytic; Drug development; Pharmaceutical biotechnology; MEDICAL / Pharmacology
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"--
Notes: Includes bibliographical references and index.