Replies to post #445269 on NorthWest Biotherapeutics Inc (NWBO)

[Kaizenman]

flipper44: You make perfect sense here.

I agree with you that theorectically, the certification of Flashworks should required a much shorter duration than what was experienced with Sawston. The primary reason is that all of the site related processes are already in place and have been certified. Besides certifying the Flashworks as a new process, they will likely have to certify the site level processes work and interact correctly with Flashworks. Finally, the procedure documentation for Flashworks should be a fraction of the documentation with the manual process.

Thanks and Peace.

[exwannabe]

Flipper, the GMP certification to use Flaskworks to manufacture DC vaccines in the IND and Specials setting is far different from certification to manufacture commercially (MAA/BLA approved).

I agree the former is "easy". The later is a far different beast as that requires demonstrating the same product is being made despite a very different process.

[dmb2]

What you write does make sense, basically the qualification of Flaskworks will be a simpler process than the original facility qualification and the current status of the Flaskworks transition is about the same as when they announced they were filing for site certification. I agree with your points as you laid them out. This would imply the Flaskworks comparability studies have been completed.

What is atypical to this situation compared to my experience is the period of time that compassionate care is being offered. Compassionate care manufacturing is commercial manufacturing, maybe or maybe not on the same scale, but it is commercial manufacturing. So, we have a situation where the company is performing commercial manufacturing but it does not yet have a commercial product. The question is do they gain approval of an improved (streamlined and automated and enclosed) process as they would if they had an approved product, meaning a submission and a review/approval by MHRA separate from their BLA, so they start to use this new process asap? Or, would such an additional submission delay the BLA submission or the BLA approval if they have initiated a rolling submission? I don't want to over complicate this but a BLA as you know is a massive undertaking and the regulatory strategy of adding the Flaskworks transition is a major additional project, unless they have timed the BLA to incorporate it, which is a lot of additional work. It can be more difficult to do a transition like this at this time because of a limited baseline of mfg processing data for comparison though the assays should be in place for all analytical work. They are following the normal path of same process between sites and then improved process post new site qualification. The complication is the BLA. It is I who has to say I hope this is making sense.

All good though knowing they are well along with their Flaskworks transition, which will occur in the near future or relatively near future.

GLTA

[antihama]

Flipper, I don’t think an inspector would need to go to Sawston to inspect the Flaskworks manufacturing set-up. Sawston was recently GMP certified meaning that the MHRA inspectors previously looked at their GMP systems (quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling) in place to perform GMP manufacturing. So whatever modifications/enhancements they make the assumption is that it is done per GMPs since Sawston has the systems in place to do so. I also base this on a reference from Lykiri, and a revelation to me, that unlike the FDA, the MHRA does not do pre-approval inspections (I’ll have to go find that link again). Number 5 on your list is the biggie.