Commercialization is not defined solely by whether some product can be sold, but by what the applicant represents as the intended commercial manufacturing route at the time of approval. Even if initial commercialization is feasible using a Grade B, artisan process, the regulator may still focus on the route intended to support ongoing commercial supply, rather than a short-term bridge.
So my concern isn’t whether the artisan process can support an initial launch — it probably can — but whether the MHRA would accept an MA that reflects a process the company already plans to replace shortly thereafter. The MHRA is quite clear when it says:
“We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.”
That raises an obvious question: when does “intent” change?
If NWBO uses the manual process for one week? Two? Five? Six?
In GZ’s email, he states:
“The build-out of manufacturing at Advent for the Flaskworks closed system has begun, as you saw in our November 20 press release. If that’s completed according to the timelines suggested in the press release, we will have to file an amendment to our (hopefully) approved MAA in order to change to the faster, less time-consuming, and more efficient closed system.”
“According to the timelines” puts this around mid-June — roughly two to three months after a manual-based MA.
Do we really think that would amuse the MHRA? How is manual the INTENDED commercial rout on such 2,3 months phase between the two (Manula MAA and Flaskworks amendment? So the core question remains: what is the intended commercial manufacturing route if Flaskworks is expected to take over two, three, or four months after approval of a manual-based MA?
Anyone with a logic mind would say at this point in time, after what has been stated by NWBO Flaskworks is the intended route and not manual.
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