2016 AIChE Annual Meeting
(661a) A QbD Approach for Identifying Critical Process Paramerters in Drug Substance Manufacturing
Authors
Michael Ryan - Presenter, Vertex Pharmaceuticals Inc.
David Willcox, Vertex Pharmaceuticals Inc.
Patricia Hurter, Vertex Pharmaceuticals Incorporated
Thomas Gandek, Vertex Pharmaceuticals Inc.
Drew Kuzmission, Vertex Pharmaceuticals Inc.
Geny Doss, Vertex Pharmaceuticals Inc.
Stephanie Krogmeier, Vertex Pharmaceuticals
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.