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008 120329s2012 flua sb 001 0 eng d
020 _a9781439829462 (ebook : PDF)
040 _aFlBoTFG
_cFlBoTFG
090 _aRS380
_b.P37 2012
092 _a615.19
_bP294
245 0 0 _aPAT applied in biopharmaceutical process development and manufacturing
_h[electronic resource] :
_ban enabling tool for quality-by-design /
_cedited by Cenk Undey ... [et al.].
260 _aBoca Raton, Fla. :
_bCRC Press,
_cc2012.
300 _axxvii, 299 p. :
_bill.
490 0 _aBiotechnology and bioprocessing series
504 _aIncludes bibliographical references and index.
505 0 _ach. 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"--
_cProvided by publisher
530 _aAlso available in print edition
538 _aMode of access: World Wide Web
650 _aPharmaceutical biotechnology
650 _aBiopharmaceutics
650 _aDrug development
655 _aElectronic books.
_2lcs
700 _aUndey, Cenk
776 _z9781439829455 (hardback : acid-free paper
856 _uhttp://marc.crcnetbase.com/isbn/9781439829462
_qapplication/PDF
_zDistributed by publisher. Purchase or institutional license may be required for access
999 _c15586
_d15586