Replies to post #258724 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Well. If you were right about only one patient's cells in a cleanroom at a time, they would need an awful lot of cleanrooms...
I therefore assume you must be wrong.

IIRC, they did a slide presentation at Phacilitate in Jan '19, which went into a degree of detail about the manufacturing process, and stated something about further manufacturing refinement meant that only 1 gram (I think) of tumor material was now needed for batch production, and they mentioned (I think) potential production capacity for Sawston (or might have been Memphis) in the tens of thousands. Which of course could not be the case, if what you asserted was accurate.

So I'll do the same as you and assert you must be wrong, then humbly withdraw my remarks if you are proved correct.

Unfortunately that slide deck, which was available on the NWBO website, appears to no longer be there.
Don't know if anybody retained it or can find it.

On the broader point: Of course, there comes a point with increasing demand you have to scale up or scale out.
But we all know this. And you expand when you are able to or when you have to.

As we know, the Car-T manufacturing process, after approval, has run into big problems. Their manufacturing still runs at 3 weeks, and they have had problems with lots of their autologous product failing QC parameters.

The whole CMC arena is what we are talking about here. And I assume NWBO are on to it.
Because if they are not, then we've got problems...

But they've long known that 'the process is the product' and have been working on streamlining production for many years.

They believe they are ahead of competitors in this regard, not behind.

[hyperopia]

ex, I think you are correct that Linda has said that the process is about 7 or 8 days. From what I understand, for autologous therapy manufacture, each patient’s own cells constitute one batch, and if the process is open, then manufacturing requires dedicated equipment and separate cleanroom processing suites to separate each patient-specific product. Each batch must be segregated to prevent cross contamination, and a high-grade cleanroom is required, typically grade B. I think Linda has talked about this slow, manual process and “men in space suits” that was used for the trial. I doubt very seriously this method will be used for commercial production however. Implementing isolators dedicated to one product or patient and/or using automated closed systems alongside single-use fluid paths would allow the processes to be fully enclosed. That approach reduces surrounding cleanroom classification to grade C. Several vendors provide fully automated and closed systems suitable for cell therapy applications. Two of these companies are Terumo BCT and FloDesign Sonics, who signed collaboration agreements with Cognate last fall.