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Re: apmarshall post# 557259

Friday, 01/06/2023 8:34:35 PM

Friday, January 06, 2023 8:34:35 PM

Post# of 827598
The Flaskworks EDEN device should be ready for mass production soon, weeks not months, IMPO.

Per the original presentation,

"One is, you're all familiar that we acquired Flaskworks, a couple of years ago in 2020. And the purpose of that acquisition was to acquire the technology, the system that they had developed to close and to ultimately automate most of the steps of the manufacturing process. And we haven't made announcements recently about this, but the entire team is working intensively on that.

I'm happy to say we feel that we've made considerable progress. Again, just to give you a flavor of it, we've tested multiple versions of the system. We've tested versions that had high rate, high flow perfusion of the culture and media. We've tested low flow or slow rate of perfusion. We've tested static cultures, all of which is to reach specifications about the yield of these products made through the automated system.

And because when we're ready, to ask for approval of this manufacturing system from regulators who are going to have to approve to their satisfaction that the product that comes out is fundamentally equivalent to the product that comes out from our manual manufacturing process today. So we've tested a number of versions of the system. We have a test system established at the Sawston facility. So there are teams working in tandem at Sawston and at Flaskworks facilities in Boston, and that is progressing."

According to my notes, the Flaskworks EDEN device is also be tested at several other Universities including other manufacturing facilities. It appears that the goal is when DCVax-L is approved, the Flaskworks EDEN device will also be ready for production since it exceeds the manual production rate by a factor of 10X to 15X, IMPO.
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