NorthWest Biotherapeutics Inc (NWBO)

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Flaskwork’s/NWBO’s IP success is very impressive. The patents themselves contain a rich source of detail. Clearly they have made advancements along the way. It’s remarkable how fast they achieve new patent grants.

Here is what Linda Powers stated 14 months ago.

Now secondly, there's a whole other picture going on while we're working on all of that. And this is work that I would describe as kind of process development and infrastructure development. These are things that we're doing to be ready for scale-up to solve bottlenecks that will otherwise be encountered when we try to scale up. And I'll just give you 3 examples of this.

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. December 30, 2022

The belief that LP should have further updated us on Flaskworks before the MAA is cemented seems like a distraction when we are on the cusp of product approval manufactured by a very legitimate and advanced cell manufacturing plant licensed, expanded and staffed to supply initial demand requirements in the UK. Also Cognate has a very large and licensed facility in the U.S., also with massive offsite storage, and it is owned by a very well resourced global company that has GMP approved facilities around the globe that could be scaled up with rapid technology transfer.

Both Cognate and Advent’s new facilities were licensed via demonstrating DCVax-l manufacturing capability.