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13 QbD in Bio Process Development and Operation


Description:
This session focuses QbD work applied to BioProcesses. Authors are invited to discuss the physical circumstance and the tools they used to quantify, visualize and define the design space.

Sponsor:
Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products
Co-Sponsor(s):
Systems and Process Design (10a), Process Development Division (12), Food, Pharmaceutical & Bioengineering Division (15)


Chair:
Ron Taticek
Director, Regulatory CMC
Genentech, Inc.
Regulatory CMC & Information Systems
1 DNA Way
South San Francisco, CA 94080
Phone Number: 650-225-3569
Email: taticek.ron@gene.com

Co-Chair:
Michael H. Henson

Papers:
233a
QbD for Biotherapeutics: Opportunities and Challenges -- An Industrial View Point
Stefanie Pluschkell, Pfizer Inc
233b
A Systems Approach for Design of Intensified Bio-Pharmaceutical Processes
Alicia Román Martínez, Technical University of Denmark; Rafiqul Gani, Technical University of Denmark; John M. Woodley, Technical University of Denmark
233c
Upstream Process Characterization Utilizing Response Surface Experimental Design: Case Study for a GS-NS0 Monoclonal Antibody Production Process
Serena Fries Smith, Merck & Co. Inc; Edith Senderak, Merck & Co. Inc; Rachel Bareither, Merck & Co. Inc; Melanie Tellers, Merck & Co. Inc; Vanessa Parikh, Merck & Co. Inc; T. Craig Seamans, Merck & Co. Inc; Michel Chartrain, Merck & Co. Inc
233d
Characterization of Monoclonal Antibody Primary Recovery and Purification Steps: Towards Process Validation
Michael Iammarino, Merck & Company, Inc.; Nihal Tugcu, Merck & Company, Inc.; Joseph Nti-Gyabaah, Merck & Company, Inc.; Martin Chandler, Merck & Company, Inc.; David Roush, Merck & Company, Inc.
233e
Improving the Batch Cycle in Bioreactors: From Media Makeup to Cleaning
Elaine Martin, University of Newcastle upon Tyne.; Gary Montague, University of Newcastle upon Tyne.
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
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