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13 QbD in Bio Process Development and Operation

Tuesday, November 10, 2009: 12:30 PM
Bayou B (Gaylord Opryland Hotel)

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
Email: taticek.ron@gene.com

Co-Chair:
Michael H. Henson
Email: henson@ecs.umass.edu


12:30 PM
(233a) QbD for Biotherapeutics: Opportunities and Challenges -- An Industrial View Point
Stefanie Pluschkell

12:55 PM
(233b) A Systems Approach for Design of Intensified Bio-Pharmaceutical Processes
Alicia Román Martínez, Rafiqul Gani and John M. Woodley

1:20 PM
(233c) Upstream Process Characterization Utilizing Response Surface Experimental Design: Case Study for a GS-NS0 Monoclonal Antibody Production Process
Serena Fries Smith, Edith Senderak, Rachel Bareither, Melanie Tellers, Vanessa Parikh, T. Craig Seamans and Michel Chartrain

1:45 PM
(233d) Characterization of Monoclonal Antibody Primary Recovery and Purification Steps: Towards Process Validation
Michael Iammarino, Nihal Tugcu, Joseph Nti-Gyabaah, Martin Chandler and David Roush

2:10 PM
(233e) Improving the Batch Cycle in Bioreactors: From Media Makeup to Cleaning
Elaine Martin and Gary Montague
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture