NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

dmb, I agree that surely Flaskworks possesses all of the relevant development documentation for their systems. However, I think the professor was just giving a general answer to a general question, and it does not appear to me to be specifically discussing the Flaskworks’ system, which was previously sold commercially by Corning.

Most of the new closed automated manufacturing systems use single-use consumables, and I think the testing that he discussed was to ensure that no chemical substances leached from the plastic consumables, which is a well-known potential issue. Corning obviously would have done this testing prior to selling their consumables for the Flaskworks system, but it’s unknown if the new supplier (Saint Gobain) can provide the same assurances, or test results, so it’s a good point.

https://www.eppendorf.com/product-media/doc/en/146279/Consumables_White-Paper_026_Consumables_Leachables-Minimizing-Influence-Plastic-Consumables-Laboratory-Workflows.pdf