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.
Thanks
Tony
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
USA
Ph: 732-227-7044
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