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newman2021

07/10/22 7:42 PM

#493821 RE: hyperopia #493819

ASM PR could reveal milestone option awards to employees for meeting the completion of Flaskwork techline, imo. Recall several months ago DI has been telling the callers about working on techline level manufacturing.

flipper44

07/10/22 7:51 PM

#493822 RE: hyperopia #493819

What do you think were the seven pieces of equipment referred to in this paragraph?


Preparations for this commercial license have included the creation of a further 50 standard operating procedures (SOPs) and policy and technical specification documents, validation of transport and shipping, and full validation and qualification of seven new pieces of equipment. Each step in such validation and qualification processes incorporates user requirement specification, design qualification, installation/operational qualification and performance qualification. This takes many months for each item of equipment. Additional controlled rate freezers were also procured, validated and qualified to expand the cryostorage capacity at the Sawston facility.

biosectinvestor

07/11/22 8:22 PM

#494059 RE: hyperopia #493819

I think this is similar to my thoughts though I do not recall a leak of any sort. I do know that Nick had a call and did have also the sense that the Flaskworks validation process was far along in the spring and likely would be finished sooner than many here expected.

As for the actual machines, one of the benefits of having the entire process happen within a cartridge that is not exposed to the environment is that in a robust manufacturing process, they should ultimately be able to handle more than one cartridge at the same time. That is the point of automation. Are you sure that machines handle one cartridge for x days? That would seem less than optimal for commercial operations and more consistent with a lab process, IMHO.