NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Thanks for the confirmation senti. I don’t think that I actually corrected you, but merely stated my understanding which was different from yours.

Yes, it’s true that fresh cells begin losing viability between 24-48 hours. As the article states, and as the CAR-T manufacturers have proven; the better the starting material, the better the final product. So, the more viable the cells are, the better. Viable cells are a very real problem for patients who've undergone radiation therapy, chemo, and are on steroids. Many years ago, there was a conversation posted between Carol Powers, who was a Patient Liaison for Northwest Biotherapeutics, and a patient who was inquiring about compassionate use of DCVax, and Carol stated that the leukapheresis material had to arrive Northwest Bio’s manufacturing facility within 20 hours for processing. So this requires that the leukapheresis procedure be performed near, and coordinated with, the manufacturing facility so that a manufacturing time slot can be reserved within the 24-hour window. Scheduling and coordinating this will become increasingly difficult as volumes increase.

I think it was biosectinvestor who said that the specialized shipping companies that handle the logistics for cell therapy companies could ship from the US just the same as shipping from the UK, but it’s simply not true. Yes, it may be possible for some hospitals that are located near an airport to ship from the US to London within a 24-48 hour window, but it’s not only the flight that takes time, there are many other logistical aspects that I won’t get into. It certainly couldn’t be guaranteed for more rural hospitals that are a distance from the airport, or require connecting flights. It’s simply not possible to transport within the window on a near-100% consistent basis, which would be necessary for commercial manufacturing. Commercial manufacturing is all about minimizing risk, and shipping fresh cells from most parts of the US would present an unacceptable supply chain risk.

So yes, the solution is to cryopreserve (freeze) the leukapheresis material, which would alleviate any time constraints that fresh blood materials present. This way, the leukapheresis procedure could be performed anywhere in the world and the material could be frozen and shipped to any DCVax manufacturing facility in the world . . . even Minneapolis. Why do you mention Minneapolis by the way? Do you know something that the rest of us don’t? Or did you mean Memphis? (Charles River Labs)

Northwest Bio (Advent) will have to determine through studies, the optimal temperature range, maximum hold time for stability, optimize the cryopreservation process, and demonstrate through an equivalency study that the cryopreserved leukapheresis material is the same as fresh leukapheresis material, which in my estimation would take at least a year or two.

I’m quite certain that they know about all this. Other CAR-T companies conducted these studies early in the development process and used cryopreserved apheresis material during their clinical trials. The question I’ve been wondering for a couple years now is; why does Advent continue to use fresh cells?

The other bottleneck that I highlighted was enlightening. I didn’t realize that demand for leukapheresis in 2027 is anticipated to be around 350,000 but the supply is only anticipated to support roughly 50,000 patients. That’s a tremendous business opportunity, that I sure hope someone will fill.