Franklin

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

Publication:
Boca Raton, Fla. : CRC Press, 2012.
Format/Description:
Book
1 online resource (320 p.)
Series:
Biotechnology and bioprocessing series.
Biotechnology and bioprocessing series
Status/Location:
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Details

Subjects:
Pharmaceutical biotechnology.
Biopharmaceutics.
Drug development.
Form/Genre:
Electronic books.
Language:
English
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-- Provided by publisher.
Contents:
Front Cover; Dedication; Contents; Foreword; Introduction; Contributors; Chapter 1: Scientific and Regulatory Overview of Process Analytical Technology in Bioprocesses; Chapter 2: Strategic Vision for Integrated Process Analytical Technology and Advanced Control in Biologics Manufacturing; Chapter 3: Multivariate Techniques in Biopharmaceutical Process Development; Chapter 4: Analysis, Monitoring, Control, and Optimization of Batch Processes: Multivariate Dynamic Data Modeling; Chapter 5: Multivariate Data Analysis in Biopharmaceuticals
Chapter 6: Process Analytical Technology Advances and Applications in Recombinant Protein Cell Culture ProcessesChapter 7: Process Analytical Technology Applied to Raw Materials; Chapter 8: Process Analysis Technology for Enhanced Verification of Bioprocess System Cleaning; Chapter 9: Cell Culture Process Analytical Technology Multiplexing Near-Infrared; Chapter 10: Process Analytical Technology for Bioseparation Unit Operations; Chapter 11: Process Analytical Technology Use in Biofuels Manufacturing
Chapter 12: Application of Microreactors for Innovative Bioprocess Development and ManufacturingChapter 13: Real-Time Monitoring and Controlling of Lyophilization Process Parameters through Process Analytical Technology Tools; Chapter 14: Process Analytical Technology's Role in Operational Excellence; Chapter 15: Conclusions, Current Status, and Future Vision of Process Analytical Technology in Biologics
Notes:
Description based upon print version of record.
Includes bibliographical references and index.
Description based on publisher supplied metadata and other sources.
Contributor:
Undey, Cenk.
ISBN:
0-429-15172-1
1-280-12184-X
9786613525703
1-4398-2946-2
OCLC:
775569804
Publisher Number:
10.1201/b11536 doi