NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Northwest Bio has said that the monocytes should arrive at their manufacturing facility within 24 hours to remain viable for the manufacturing of DCVax, but generally fresh monocytes remain viable for 24 to 48 hours. I posted about this not too long ago:

With fresh monocytes, there’s a limited window (24-48 hours) in which manufacturing should take place because cell viability decreases after that time. Therefore, manufacturing timeslots have to be reserved for each patient prior to undergoing leukapheresis. This presents logistical challenges if there are shipping delays, or if sick patients miss their leukapheresis appointment, which can cause cancelled manufacturing slots and rescheduling backlogs. During the trial, there were only a few hundred patients treated over many years, so these issues could be overcome fairly easily. But this becomes a nightmare for commercial manufacturing when hundreds of patients a month from all over the country are being scheduled. The solution is to cryopreserve the leukapheresis material, which not only provides scheduling flexibility, but also allows centralized manufacturing from a greater distance. Unfortunately, this requires comparability studies to show the equivalence of cryopreserved cells to fresh cells. The question is: who will perform the comparability studies, and when? By the way, Kite performed the comparability studies early in the development of Yescarta, and used cryopreserved leukapheresis material during their clinical trials so they were well prepared for commercialization.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165199072