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Replies to post #605603 on NorthWest Biotherapeutics Inc (NWBO)
“….otherwise I’m not wasting my time.” Hyperopia
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.
The final product is tested for identity, purity, potency, and stability against pre-established release criteria for the product. And then as I just said, there are a number of additional tests (sterility, endotoxin, mycoplasma) to ensure that the product contains no contaminants. All of this testing takes about a month or more.
Hi xxxxx,
It is potentially possible, but the viability and potency of the dendritic cells may not be as good as when they are fresh.
LL
