I do agree that automation with Flaskworks is very important. Especially with increasing DCVax-L production capacity by a multiple of 10, compared to using clean rooms without Flaskworks.
However, I don’t believe that the FDA, MHRA, Health Canada and the EMA are requiring that Flaskworks be incorporated into the production process before issuing the initial regulatory approvals of DCVax-L. I believe that the clean room production capacity at Cognate/CRL and Advent are currently sufficient enough for initial approval of DCVax-L.
But, because of the eventual worldwide demand for DCVax-L, it will be important that NWBio complete the DCVax-L equivalency and comparability tests with Flaskworks as soon as possible to reach the DCVax-L manufacturing capacity required to scale and meet DCVax-L commercial demand worldwide.
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