This message was posted by a user wishing to remain anonymous
At a CDMO, and struggle with the same challenge. We are going global, and the DMF is not universal. Assume confidentiality agreement and Quality agreement is in place:
I suggest a generic 32A1 (~10 pages), likely with drawings that will need to be maintained and updated in parallel for all commercial clients.
The list of products in the plant is most challenging. I keep two, one remaining confidential to send directly to regulators, and a "blinded" one that is high level enough that it may be shared. "CHO based oncology product". For both, add a statement that nothing is highly potent or toxic.
The mainenance and notification of changes is the real issue, and should be tied to annual reviews. I think we are obligated to maintain any commercial submission, but for clinical submissions it may be a negotiation between you and the client if a US trial and they do not accept the LOA. You are providing an accurate snapshot of the state of the facility at the time of production for the clinical material.
Original Message:
Sent: 23-Sep-2019 17:05
From: Anonymous Member
Subject: Type V DMF LOAs for BLAs
This message was posted by a user wishing to remain anonymous
I represent a CMO that manufactures biologic and drug products. Our clients have historically requested a Letter of Authorization (LOA) to our Type V DMF. However, recently we have had more Biologic clients pushing back against the LOA based upon the June 2019 Federal Register Docket No. FDA-2019-N-1363.
My question is how are CMOs protecting the confidentiality of their clients and facility processes without referencing their DMFs, while still providing information needed by clients for successful submissions?