661 Quality By Design in Drug Substance Process Development

Thursday, November 17, 2016: 8:30 AM - 11:00 AM
Continental 4 (Hilton San Francisco Union Square)
Description:
Modernization of regulatory processes in the pharmaceutical industry has led to several innovative approaches to risk-based implementation of Quality by Design. Speakers for this session should include topics describing their application of QbD principles with examples of determination of critical process parameters (CPPs), mapping of design spaces (DS), real time process monitoring, and the determination of appropriate control strategies for small and large molecule drug substance processes.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B)

Chair:
Joe Hannon
Email: joe.hannon@scale-up.com

Co-Chair:
Kevin Seibert
Email: seibertkd@lilly.com


8:30 AM
(661a) A QbD Approach for Identifying Critical Process Paramerters in Drug Substance Manufacturing
Michael Ryan, Geny Doss, Thomas Gandek, Patricia Hurter, Stephanie Krogmeier, Drew Kuzmission, Adam Looker, William Rowe, Derek Vrieze and David Willcox

9:33 AM
(661d) New Trends in Materials-Sparing and Modelling Approaches Towards Pharmaceutical Development
Jasmine M. Rowe, Xiaodong Chen, Johnathan M. Goldman and Faranak Nikfar

9:54 AM
(661e) The Journey of Mechanistic Models from Design to Optimization/ Launch… and Beyond
Carla Luciani, Salvador García-Muñoz, Kevin Seibert, Eric Crick, Thomas Wilson, Michael Kobierski and Colm O'Mahony

10:36 AM
(661g) Case Study:  QbD Approach to Design Space Verification
David Willcox, Brian Phenix and Billie Kline