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I do not believe the Comparability Protocol guidance applies to Phase 2 material, only changes once in Commercial Distribution.
FDA did however issue a guidance called INDs for Phase 2 and Phase 3 Studies, Chemistry, Manufacturing, and Controls Information, May 2003, that covers changes quite a bit:
https://www.fda.gov/media/70822/download
Original Message:
Sent: 28-Mar-2020 08:43
From: Arvilla Trag
Subject: Changing manufacturing site for Phase 2 material
Guidance:
- FDA: Comparability Protocols for Human Drugs and Biologics
- ICH Q5E: Comparability of Biotech Products Subject to Changes in their Manufacturing Process
FDA slide presentation: Regulatory Perspective on Comparability Assessments of Biotechnology Products (very informative)
As far as stability goes, Q5E recommends accelerated and forced degradation studies to evaluate any changes. I would also put product on a routine stability study and submit whatever data you have from that at the time you submit the accelerated and forced degradation data.
Happy weekend!
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Arvilla Trag RAC
Principal Consultant
Iron River MI
United States
Original Message:
Sent: 27-Mar-2020 10:14
From: Mariia Johnson
Subject: Changing manufacturing site for Phase 2 material