469184 Case Study:  QbD Approach to Design Space Verification

Thursday, November 17, 2016: 10:36 AM
Continental 4 (Hilton San Francisco Union Square)
David Willcox, Vertex Pharmaceuticals Inc., Boston, MA, Brian Phenix, Chemical Development, Vertex Pharmaceuticals, Boston, MA and Billie Kline, Chemical and Materials Engineering, Vertex Pharmaceuticals, Boston, MA

Design Space Verification was completed for a recent regulatory filing using the Quality by Design paradigm for a drug substance process. A risk analysis approach was utilized to identify the key issues to address in order to verify that the design spaces derived from laboratory scale experiments were appropriate for commercial scale production.

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