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
[log in to unmask]
This message (including any attachments) may contain confidential, proprietary, privileged and/or private information. The information is intended to be for the use of the individual or entity designated above. If you are not the intended recipient of this message, please notify the sender immediately, and delete the message and any attachments. Any disclosure, reproduction, distribution or other use of this message or any attachments by an individual or entity other than the intended recipient is prohibited.
The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community. Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
Avista Pharma Solutions - http://www.avistapharma.com/
Comprehensive testing and CMC services organization
Analytical and Microbiology support to early stage API and drug product development and manufacturing.
BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
Cincinnati Sub-Zero - http://www.cszindustrial.com/
Provides a large selection of environmental chambers from benchtop, reach in to walk-in
rooms along with chambers for freeze/thaw, temperature cycling applications.