Under MHRA ATMP rules, the MA must reflect the actual intended commercial manufacturing route and NWBO themselves stated that Flaskworks is “key” and “central” to commercialisation. Manual B-labs cannot be approved as the commercial route when the company has already committed to a different process. Everything else is wishful thinking.
The use of IFRs during the interim allows for best use of funds during the transition time which I believe wouldn’t start until Flaskworks is demonstrated to be a viable solution. This would mean demonstrating ability to perform at commercial scale ie engineering runs, initial comparability and other with a full GMP unit prior to full validation of layout at commercial scale with multiple units in place. Once MHRA is satisfied with sufficient progress to take into account their projections for demand and the labeling phase ended then approval would be the next step. The moves made to prepare for increased capacity of leukapheresis and manufacturing with Class C clean room expansion before an approval is granted point to this as required preparation. IFRs appear set to act as a temporary restriction of access and allow for the panel deciding on grants to choose those most likely to benefit out of broader demand until Flaskworks is fully validated and in use. Best wishes.
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