This PR is pretty big news, so don’t be fooled by the supposed “market” reaction. Commercial GMP regulations are extremely stringent, and licensing the Sawston facility for commercial manufacturing would be a significant achievement for an experienced Big Pharma company, let alone for Advent, a relatively small and inexperienced CDMO. To me, it makes this milestone all the more impressive, especially in light of the mentioned shortage of GMP experts in cell manufacturing, and equipment shortages and delays.
So we now know that all of the additional commercial GMP SOP’s and documentation required for cleaning, packaging, distribution, etc., have already been drafted, and all of the required qualification, validation and comparability work for all of the equipment used in the commercial process has been accomplished. Yes, this means that Flaskworks system is now ready for commercial production.
This PR also confirmed that Advent has installed, and will be using an automated fill and finish system, so all of the major manufacturing processes can be done in the same low-level cleanroom environment, which should lower cleanroom and personnel costs right from the start.
This manufacturing readiness also means that all the the manufacturing information that is needed for a marketing application should now be available. (except possibly some stability data, which can be submitted later)
I believe the MHRA has a policy to process the application in 90 working days, but as we’ve seen, it can take longer if there are backlogs. I also recall reading somewhere that this inspection could be processed more rapidly if it’s in conjunction with a marketing application though. (as in a pre-approval inspection)
