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Replies to post #588788 on NorthWest Biotherapeutics Inc (NWBO)
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. — Linda Powers December 21, 2022
[/DI went on to say "Our comm license was for the production we were doing for specials and clinical trials. Flaskworks is being worked on to integrate into our facility for some time".quote]
if Estevito's quote of DI's reply is correct, Flaskworks is still very much in the picture and SM's departure may simply mean that he successfully finished the work that he was assigned to do.
04/26/23 2:10 PM
04/26/23 3:04 PM
04/26/23 4:18 PM
Presenter Speech
Linda Powers (Executives)
So good afternoon, everybody. Thank you so much for coming to our Annual Meeting of Stockholders of Northwest Biotherapeutics. It's 1:30 p.m. East Coast Time, and the meeting is called to order, and the polls are now open. Our agenda for this year's annual meeting will be as follows. First, I'll introduce the company's directors and officers.
Our annual meeting -- then we'll introduce the 6 proposals that stockholders are being asked to vote on. Following that introduction, we'll discuss the proposals and open and close the polls. After the closing of the polls, we will provide the stockholders with a report of the election results.
Now secondly, there's a whole another 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.
So that is one area that is continuing to be worked upon. Another area that we haven't talked about publicly before. We haven't discussed is another aspect of producing these products. It's not just that you manufacture them. You -- after you finish manufacturing, which, as you know, our process is very efficient. It takes 8 days. It's a really good process.
Then you have to do quality control tests and you have to do -- go through a process called product release, product has to be -- only if a product successfully passes all of the quality control tests is it able to be released for use in human patients. The product release step is one thing when you're doing a release on a huge batch of millions of pills that are all the same. But this is a fully personalized product, each patient’s product has to be released individually separately.
Well, if you think about it, that could be a bottleneck for scale up. And not only does the product have to go through the quality control test, the person who's conducting the evaluation for the product release, which is a person who has to have a special certification in order to do it. In the U.K., this person is called a QP, a qualified person [indiscernible]. And it has to be a very specialized certified person to do it. They have to not only review the results of all of the quality control tests, the composition of the product, the purity, the potency, the sterility.
They have to not only do all that, they even have to review things like the readouts from the environmental monitoring centers that were in the clean room suite for the entire 8-day process that the product was made to make sure that the particles in the air, and the air goes through 60 air changes per hour, an entire air change per minute in these clean room suites have to check that the particle count didn't exceed the tolerance limits and that all the GMP requirements were met.
Well, that's a big thing. And it can take as much as 30 hours of a qualified person to release a product. So we started more than 3 years ago, okay, not weeks, not months, we started more than 3 years ago with [Advent ] and working on arrangement to develop ways that the product release process could be automated or at least partially automated. So as to not have a bottleneck on this and be ready for scale up.
And we're not ready to make an announcement yet, but suffice it to say that's been an area of a big amount of work and a big amount of focus. And we haven't talked about it because we weren't at the stage yet to have something completed. But there's a lot of things that we work on behind the scenes that are forward looking of what do we have to be ready for a year from now, 2 years from now, 3 years from now, because with the time lines involved, if we need something 2 years from now, we have to start today.
And this product release system has been more than 3 years already so far. So that's just another example. The last example that I'll just give is infrastructure. As I think you know, the operational model that we plan to use going forward is the same as what we have used during the clinical trial, which is when the product gets manufactured.
And as I think everybody knows, a whole set of doses for a patient gets manufactured in 1 batch, right? That's part of the efficiency. We store those doses on a centralized basis. That's a risk management choice on our part right now. We send the doses when it's time for them to be administered because these are precious, individualized, irreplaceable doses. It's not just like if we send it to a hospital pharmacy and a hospital pharmacy doesn't handle it properly,oh well, we'll send another batch of pills, no.
So we do centralized storage. We have a lot of experience with this now. We did it during the clinical trial. That also means we need to be ready with large-scale capacity. And just as 1 aspect of that, we have to have controlled cryo storage. So we have to have controlled resource capacity for all these doses. Well, we already have existing physically in place now, controlled cryo storage capacity for up to 3 million doses, okay?
So this is, again, something that we've been working on for quite some time. Okay. That was a long discussion of kind of where are we, what are we working on behind the scenes, where do we go next is these applications for approval and not some of kind of what's involved. We don't have massive amounts of time left. So I'm going to go through the other questions more quickly.
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