Lykiri, I have never worked directly with apheresis operations nor am I familiar with the particulars of UK vs USA guidelines for operating such centers. I have been in mfg plants which process blood products and have seen the controls needed. But I can emphasize the reason the CEO in the interview you included stated the need for experienced individuals is there are nuances in these processes just as there are nuances in every step of biopharmaceutical processing.
Since cellular processing is still in its early development in some ways the regulations will lag behind, particularly the intl coordination efforts which need to coordinate cellular processing across borders. To be in the development wave of such newer intl regulatory coordination can be resource and time consuming and a large undertaking for small companies.
I am sure that when processes such as leukapheresis are used to source material for biopharma processing these processes will draw new scrutiny on the collection standards and may necessitate new additional tests and steps to secure and preserve the material if needed, particularly if sourcing countries have different standards than processing countries.
And to answer your question, yes any details of the collection, testing, transportation and storage of the cellular material that can impact the quality, purity and sterility characteristics of the starting material, which can affect the final product, will be defined in the MAA from leukapheresis to infusion. Collection and handling of the starting material is expected to be performed in a standardized way unless it can be proven that it is not necessary to do so because of the downstream processing. Generally speaking the level of standardized control is the responsibility of the sponsoring company to define and complete standardization is expected unless a defined tolerance is proven such as in temperature tolerance during shipping as proven in stability studies.
I do believe that any and all of the steps starting with leukapheresis standards have come under intense scrutiny throughout the development and MAA compilation process for DCVax-L and any time a sponsoring company files an application for new capabilities, particularly when the guidance for such capability is new, that there is plenty of room for question and delay to address such RA questions. In such circumstances, particularly when Orphan Designation is granted, there is good reason to explore advantageous regulatory tactics and the door to discuss with the RA is open.
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