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Re: Lykiri post# 605016

Tuesday, 06/27/2023 11:31:24 PM

Tuesday, June 27, 2023 11:31:24 PM

Post# of 700308
Thanks Lykiri (and sharpie), that’s some good diligence. (and also a good reminder to - help Tracy)

I don’t think that this actually disproves that fresh monocytes are used. For one thing, that picture is of fresh leukapheresis material, and the labeling states that it is “non-mobilised” and must be “used within 48 hours, and stored between 20-25C” (68-77F), so definitely not cryopreserved. (and likely not intended to be with that label)

Where did you read that quality control testing only takes 2 days? The last manufacturing timeline I read (according to Carol Powers almost 10 years ago), it takes 8 days to manufacture the vaccine, and an additional 35-40 days for final product testing. Although this may be shortened somewhat by now (especially with in-process testing), I don’t think 2 days for final-product testing is correct, since sterility testing alone would likely take a couple weeks (samples must be incubated for that long to detect evidence of microbial contamination). So a leukapheresis date of 12 June, and an availability date of the vaccine by the middle to end of July, would still be consistent with that. (the final product will be frozen, which allows some flexibility for the exact patient-administration date)

Also not sure why else the patients would have to fly to London for the leukapheresis procedure if the blood draw was frozen. (unless maybe Northwest Bio’s exact cryopreservation procedure wasn’t yet established at other hospitals outside of London? But if cryopreservation was being developed with a London hospital, then the labeling would be different, so likely still fresh.)
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