March 2017


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"Mazzeo (R&D), Tony" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Mon, 6 Mar 2017 20:14:19 +0000
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Hello stabilitarians,

Does anyone have any experience with filing an NDA using pilot scale drug substance batches (primary stability batches) that were manufactured at two different manufacturing facilities, e.g. one batch at a pilot plant and the others at the commercial site?

If, so, did you run into any issues with the ICH country reviewers or non-ICH reviewers?

I would appreciate hearing about your experiences.


Anthony R. Mazzeo, Ph.D.
Senior Principal Scientist
Analytical and Bioanalytical Operations
Pharmaceutical Development Department

Bristol-Myers Squibb Company
1 Squibb Drive
New Brunswick, New Jersey 08903-0191

Ph: 732-227-7044
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