Avid Bioservices Inc (CDMO)

[skweze]

Probably makes sense to already own the capacity in a validated facility. Disposable technology also affords maximum flexibility and accelerates start up ...no cleaning validation, etc. All imo.

Yes there is an FDA requirement.

Says, FDA Jeanette Woodcock herself in an interview that was posted here.
She argument it with the fact that if such a form of early access is granted and the public then wants the drug, it would be unethical to allow manufacturers not to be able to deliver.

And so she EXPLICITLY said that one of the things the FDA looks at for granting it is the capacity. Now that being said doesn't mean you need to OWN that capacity. I suppose that is you have the needed sub-contractors and some kind of agreement that you can call of GUARANTEED production batches on YOUR TIMELINE NEEDS it will be ok too.