Session 5: Round Table: Quality by Design (QbD) and Design of Experiments for Development: Elements, Regulatory Requirements and Tools
Tuesday, November 10, 2015: 1:00 PM-4:30 PM
Grand Ballroom F-G (Hilton Clearwater Beach Hotel)
Conveners:
Zhibiao Fu - GlaxoSmithKline and Ryan Hamilton - Genentech, Inc
Co-Convener:
Aili Cheng - Pfizer Global Reseach and Development
QbD is a science- and risk-based approach for process development and manufacturing, requiring extensive information about the product and its manufacturing process. This session will focus on recent advances in process development withQbD and DOE multivariate analysis, the opportunities and challenges. There will be presentations from five speakers followed by a round table discussion.

1:00 PM
S27
QbD Strategies Employed for a Biopharm Fermentation Process: A Customer’s Perspective
S. Weisser*, J. Aon, E. Appelbaum and Z. Fu, GlaxoSmithKline, King of Prussia, PA
Weisser, RAFT 2015, Qbd Strategies for a Biopharm Fermentation Process.pdf
1:30 PM
S28
Microbial Fermentation Scale Down Model Qualification – A Case Study
K. Veeravalli*, R. Hamilton, J. Burr and M. Laird, Genentech, Inc, South San Francisco, CA
2:00 PM
S29
Concepts and Tools for Building Models for Design Space
J. Peterson*, GlaxoSmithKline, Collegeville, PA
2:30 PM
Break - Exhibits Open
3:00 PM
S30
Use of quality by design elements in process characterization 
J. Gunson*, Genentech, Inc, South San Francisco, CA
3:30 PM
S31
Developability and pre-process risk assessment in biopharmaceutical development: a critical aspect in QbD implementation
J. Zurdo*, A. Arnell, R.G. de la Cueva, N. Smith and O. Obrezanova, Lonza Biologics plc, Cambridge CB21 6GS, UK
See more of: Invited Papers
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