PAT applied in biopharmaceutical process development and manufacturing an enabling tool for quality-by-design
by
 
Undey, Cenk.

Title
PAT applied in biopharmaceutical process development and manufacturing an enabling tool for quality-by-design

Author
Undey, Cenk.

ISBN
9781439829462

Publication Information
Boca Raton, Fla. : CRC Press, c2012.

Physical Description
xxvii, 299 p. : ill.

Series
Biotechnology and bioprocessing series

Series Title
Biotechnology and bioprocessing series

Contents
ch. 1. Scientific and regulatory overview of process analytical technology in bioprocess / Rakhi B. Shah ... [et al.] -- ch. 2. Strategic vision for integrated process analytical technology and advanced control in biologics manufacturing / Melissa M. St. Amand ... [et al.] -- ch. 3. Multivariate techniques in biopharmaceutical process development / Jeremy S. Conner -- ch. 4. Analysis, monitoring, control, and optimization of batch processes : multivariate dynamic data modeling / Theodora Kourti -- ch. 5. Multivariate data analysis in biopharmaceuticals / Joydeep Ganguly ... [et al.] -- ch. 6. Process analytical technology advances and applications in recombinant protein cell culture processes / Ana Veronica Carvalhal and Victor M. Saucedo -- ch. 7. Process analytical technology applied to raw materials / Erik Skibsted -- ch. 8. Process analysis technology for enhanced verification of bioprocess system cleaning / Peter K. Watler ... [et al.] -- ch. 9. Cell culture process analytical technology multiplexing near-infrared / Mariana L. Fazenda, Linda M. Harvey, and Brian McNeil -- ch. 10. Process analytical technology for bioseparation unit operations / Anurag S. Rathore, Vishal Ghare, and Rahul Bhambure -- ch. 11. Process analytical technology use in biofuels manufacturing / Pedro Felizardo, Jos ̌C. Menezes, and M. Joana Neiva-Correia -- ch. 12. Application of microreactors for innovative bioprocess development and manufacturing / Seth T. Rodgers and A. Peter Russo -- ch. 13. Real-time monitoring and controlling of lyophilization process parameters through process analytical technology tools / Feroz Jameel and William J. Kessler -- ch. 14. Process analytical technology's role in operational excellence / Fetanet Ceylan Erzen and Manbir Sodhi -- ch. 15. Conclusions, current status, and future vision of process analytical technology in biologics / Duncan Low and Ray Chrisman.

Abstract
"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.

Subject Term
Pharmaceutical biotechnology.
 
Biopharmaceutics.
 
Drug development.

Added Author
Undey, Cenk.

Electronic Access
Distributed by publisher. Purchase or institutional license may be required for access.


LibraryMaterial TypeItem BarcodeShelf Number[[missing key: search.ChildField.HOLDING]]Status
Online LibraryE-Book286144-1001ONLINEElektronik Kütüphane