I don’t dispute that the artisan/manual process is technically capable of producing commercial product at limited scale, nor that NWBO may genuinely intend to use it for an initial rollout or bridging period. From a pure capacity perspective, that route is indeed viable in the short term.
Where I see the potential disconnect is more regulatory than practical.
The MHRA language focuses on the “commercial manufacturing process intended for the MA”, not merely on whether an older process could still be used temporarily. Once an applicant has clearly identified a new process as the intended commercial route, the regulator typically expects the MA to reflect that route — even if a legacy process could still function as a bridge.
In other words, the key question is not whether the artisan process can be used commercially, but whether it is considered the intended commercial manufacturing route at the time the MA is granted. If NWBO can genuinely and credibly represent to the MHRA that:
the artisan process is the intended commercial route at approval, and
Flaskworks is a subsequent post-approval change,
then your interpretation would be correct, and Flaskworks would not be MA-critical.
My concern is simply that once Flaskworks has been positioned — internally or externally — as the commercial endpoint, the regulator may reasonably expect that route to be reflected in the MA, even if the bridging period is relatively short. So I don’t claim certainty here, and I agree this hinges on how NWBO has framed its intent to the MHRA. I just think the MHRA’s wording leaves less flexibility than many assume.
As I have said here before, NWBO may find the MHRA very displeased if, as NWBO itself states, it intends to change the intended manufacturing route shortly after MA approval while the MA is based on the manual process. For that reason, the MHRA could, as I have been saying, suspend or refuse to finalise an MA based on the manual route.
That said, I agree that the MHRA will not read or respond to NWBO’s press releases. If NWBO did not tell the MHRA about their intended manufacturing route, Flaskworks, then that can be interpreted as misleading the MHRA> Its that simpe.
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