472207 A QbD Approach for Identifying Critical Process Paramerters in Drug Substance Manufacturing

Thursday, November 17, 2016: 8:30 AM
Continental 4 (Hilton San Francisco Union Square)
Michael Ryan, Geny Doss, Thomas Gandek, Patricia Hurter, Stephanie Krogmeier, Drew Kuzmission, Adam Looker, William Rowe, Derek Vrieze and David Willcox, Vertex Pharmaceuticals Inc., Boston, MA

The Vertex approach to critical process parameter identification via an effect threshold concept will be discussed and accompanied by examples applying the method to drug substance development and manufacture.

Extended Abstract: File Not Uploaded