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Re: meirluc post# 556805

Thursday, 01/05/2023 11:19:24 PM

Thursday, January 05, 2023 11:19:24 PM

Post# of 700606
meirluc, that is certainly a reasonable way to read it. I don’t think they really knew how long it will take to get the Flaskworks process approved, and I think they are adding cleanrooms at Sawston because they will need the extra cleanroom space for commercial production demands, whether it begins manual or automated. I think it would depend on where Flaskworks is in the comparability/approval process when DCVax is approved. It has always been questionable to me whether NICE would approve the high cost of DCVax with manual production, so I’ve thought that they’d wait for the Flaskworks system if it was reasonably close to approval.

I don’t know what grade of clean rooms are currently being built, but I’m speculating there will be a mix of both high (grade B) and low level (grade C & D), similar to phase 1a. Even with the closed, automated production process with the Flaskworks’ system, a low level of cleanroom is needed, generally a C or D grade. Additionally, there are still some processes, like the lysate preparation, assay testing, etc., that will require higher level, B-grade clean rooms.
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