flipper44,
Dr. Mark Lowdell has also worked with NWBO and describes these cell therapy hang ups in this reference piece as related to all cell therapy. The conclusions section points out the need for digitization which points to release by exception to greatly reduce demand on the time of the QP overseer of quality control which in the U.K. is done for each batch. NWBO described this process as highly time consuming with over 30 man hours needed per batch. This all must be validated at each manufacturing site and each manufacturing site listed on a BLA/MAA application. Dr. Lowdell also mentioned that individual components must all pass muster in any jurisdiction that the product passes through and gave an example of a reagent acceptable in one jurisdiction but not another. With NWBO suggesting that Memphis is in the plans, perhaps as backup or other, they too must pass muster before submission(s) if they are to be potentially utilized.
Then there is the issue of future demand for leukopheresis vs current capacity which Lykiri found severely under prepared for as described in post 604399 in an article by Mark Sawicki. Current capacity, I am assuming US although US and EU were mentioned in a previous paragraph, as of 2022 being 9,000 per quarter and projected to be 13,000 per quarter in 2027 vs demand for 90,000 by then. There is tighter definition of regulation of leukopheresis products in the U.K. vs US too that needs or needed to be worked out.
I expect as you do that product release issues are pretty far advanced towards being worked out for NWBO but with this taking so long Edens must be running into the picture by now. Edens is one step closer to the black box picture of closed system manufacturing considered the ideal in Dr. Lowdell’s article. Best wishes.
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