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TitlePAT applied in biopharmaceutical process development and manufacturing : an enabling tool for quality-by-design
Author edited by Cenk Undey... [et al.]
Imprint Boca Raton, FL : CRC Press, c2012
Descript xxvii, 299 p. : ill. ; 25 cm.

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


CONTENT

Scientific and regulatory overview of process analytical technology in bioprocesses -- Strategic vision for integrated process analytical technology and advanced control in biologics manufacturing -- Multivariate techniques in biopharmaceutical process development -- Analysis, monitoring, control, and optimization of batch processes: multivariate dynamic data modeling -- Multivariate data analysis in biopharmaceuticals -- Process analytical technology advances and applications in recombinant protein cell culture processes -- Process analytical technology applied to raw materials -- Process analysis technology for enhanced verification of bioprocess system cleaning -- Cell culture process analytical technology multiplexing near-infrared -- Process analytical technology for bioseparation unit operations -- Process analytical technology use in biofuels manufacturing -- Application of microreactors for innovative bioprocess development and manufacturing -- Real-time monotoring and controlling of lyophilization process parameters through process analytical technology tools -- Process analytical technology's role in operational excellence -- Conclusions, current status, and future vision of process analytical technology in biologics


Pharmaceutical biotechnology Biopharmaceutics Drug development

LOCATIONCALL#STATUS
Pharmaceutical Sciences LibraryRS380 P37 2012CHECK SHELVES

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