Dear Anon,
Yes, you can make the change to improve your productivity and process. Just design some analytical bridging study and if all goes well there is no need to repeat the tox. Don't forget to submit all the information in an IND amendment before using the new material in clinical studies.
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Gene Zhu
Principal Consultant
Pasadena, CA
USA
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Original Message:
Sent: 21-Dec-2021 16:56
From: Anonymous Member
Subject: Cell culture medium change
This message was posted by a user wishing to remain anonymous
Hello, Raps community,
Our company received ok to proceed from FDA for phase I IND submission. We use company A's base medium and feeds for the upstream process. Can we change the medium system (both base medium and feeds) at this stage? If so, do we need to redo the TOX study using the new medium system? Thank you.