عنوان

PAT applied in biopharmaceutical process development and manufacturing :

(Number (ISBN

128012184X

(Number (ISBN

1439829462

(Number (ISBN

9781280121845

(Number (ISBN

9781439829462

Number

b567603

Title Proper

PAT applied in biopharmaceutical process development and manufacturing :

General Material Designation

[Book]

Other Title Information

an enabling tool for quality-by-design

First Statement of Responsibility

edited by Cenk Undey [and others].

Place of Publication, Distribution, etc.

Boca Raton, Fla.

Name of Publisher, Distributor, etc.

CRC Press

Date of Publication, Distribution, etc.

©2012.

Series Title

Biotechnology and bioprocessing series, 33.

Text of Note

Ch. 1. Scientific and regulatory overview of process analytical technology in bioprocess / Rakhi B. Shah [and others] --; ch. 2. Strategic vision for integrated process analytical technology and advanced control in biologics manufacturing / Melissa M. St. Amand [and others] --; 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 [and others] --; 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 [and others] --; 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, José 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.

Text of Note

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.

Biopharmaceutics.

Drug development.

Pharmaceutical biotechnology.

Class number

Book number

edited by Cenk Undey [and others].

Cenk Undey

Electronic name

[Book]

Y