高雄醫學大學圖書館 |

PAT applied in biopharmaceutical process development and manufacturingan enabling tool for quality-by-design /

Record Type:	Language materials, printed : Monograph/item
Title/Author:	PAT applied in biopharmaceutical process development and manufacturing/ edited by Cenk Undey ... [et al.].
Reminder of title:	an enabling tool for quality-by-design /
other author:	Undey, Cenk.
Published:	Boca Raton, Fla. :CRC Press, : c2012.,
Description:	1 online resource.
基督教聖經之智慧書導讀 :	"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"
Subject:	Pharmaceutical biotechnology. -
Online resource:	http://ezproxy.lb.polyu.edu.hk/login?url=http://site.ebrary.com/lib/polyu/docDetail.action?docID=10525006
ISBN:	9781439829462 (electronic bk.)

PAT applied in biopharmaceutical process development and manufacturingan enabling tool for quality-by-design /
PAT applied in biopharmaceutical process development and manufacturingan enabling tool for quality-by-design /[electronic resource] :edited by Cenk Undey ... [et al.]. - Boca Raton, Fla. :CRC Press,c2012. - 1 online resource. - Biotechnology and bioprocessing series ;33.. - Biotechnology and bioprocessing series ;33..

Includes bibliographical references and index.

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�e 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.

"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"

ISBN: 9781439829462 (electronic bk.)Subjects--Topical Terms:

220259
Pharmaceutical biotechnology.
Index Terms--Genre/Form:

228523
Electronic books.

LC Class. No.: RS380

Dewey Class. No.: 615.1/9

PAT applied in biopharmaceutical process development and manufacturingan enabling tool for quality-by-design /
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245 0 0 $a PAT applied in biopharmaceutical process development and manufacturing $h [electronic resource] : $b an enabling tool for quality-by-design / $c edited by Cenk Undey ... [et al.].
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300 $a 1 online resource.
490 1 $a Biotechnology and bioprocessing series ; $v 33.
504 $a Includes bibliographical references and index.
505 0 $a 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�e 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.
520 $a "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"
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