(661a) A QbD Approach for Identifying Critical Process Paramerters in Drug Substance Manufacturing | AIChE

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(661a) A QbD Approach for Identifying Critical Process Paramerters in Drug Substance Manufacturing

Authors 

Ryan, M. - Presenter, Vertex Pharmaceuticals Inc.
Willcox, D., Vertex Pharmaceuticals Inc.
Hurter, P., Vertex Pharmaceuticals Incorporated
Gandek, T., Vertex Pharmaceuticals Inc.
Looker, A.
Kuzmission, D., Vertex Pharmaceuticals Inc.
Doss, G., Vertex Pharmaceuticals Inc.
Krogmeier, S., Vertex Pharmaceuticals
Vrieze, D.
Rowe, W.
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.

Topics 

Process Design & Development
Regulations

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