WRONG.
MHRA requires that the intended commercial manufacturing process be assessed before granting a marketing authorisation for an ATMP.
Direct quote from MHRA’s own GMP inspectorate: “The MHRA require you to fully demonstrate your ability to consistently and correctly manufacture your ATMP in order to obtain an authorisation.”
If Flaskworks/Grade C is the commercial route (NWBO explicitly stated it is “central to large scale-up”), then that is the process that must be validated, inspected and reviewed as part of the MAA. Manual Grade B is pilot-scale, not the commercial plan and that is NWBO’s own wording, not mine. Im asthonised you and the lot of you refuse to accept the last NWBO PR in that regard.
You cannot submit an MAA with Process A (manual) and commercially supply Process B (Flaskworks). MHRA inspects and approves the process that will actually be used. If the commercial route changes during review, the dossier must be updated and the review will pause until the new CMC is assessed. MHRA explicitly classifies this as a sponsor-side clock-stop. Flaskworks is not a Type II variation. A Type II variation is only allowed when the originally approved process remains commercially viable. Manual is not. NWBO said it themselves: Flaskworks/Grade C is required for scalable commercial production. That makes the automation pathway part of the active MAA, not a post-approval convenience update.
ATMP law is clear:
A major manufacturing-platform change (manual ? automated closed system) must be included in the MAA assessment.
Not after approval.
Not “later.”
Not optional.
But hey whatever makes you sleep better at night
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