I have never been in this situation, so I can't say for sure it would be accepted, but I don't see why it wouldn't be. Just be very clear about what data you have at what age. You have the data on the CofA, then start testing at whatever age it is. I do think this is one of the situations where it might depend on the data. If everything stays flat as expected, then there shouldn't be a problem. If you get a weird result, then you might have to go back and start over, or at least start with newer material to get a bit more data on the stability trends within the approved shelf life.
But as I said, I have no experience with this, so I'm just speculating.
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Rachel Thornton
Associate Director
Smyrna GA
United States
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Original Message:
Sent: 18-Jan-2022 16:51
From: Anonymous Member
Subject: Extending Shelf-Life of Biologic API
This message was posted by a user wishing to remain anonymous
Hello Forum Members,
We currently obtain our API (a 51-amino acid protein manufactured using recombinant technology) from a vendor and reference their US DMF in our BLA (this approach was "grandfathered" when our NDA was deemed a BLA in March 2020).
The vendor has only conducted sufficient stability testing to support a 5 year shelf life and will not conduct additional testing to extend the shelf life. The API shows no degradation when stored frozen so we are fairly confident the shelf life could be extended.
Can we just take API near the 5 year expiry and start our own stability program to perform the testing beyond the 5 years to demonstrate it continues to meet specifications (ie leverage the vendor's data for the first 5 years)? Or does our program need to be documented "a priori" and utilize newly manufactured API?
Thank you in advance for your input!