Agree flipper, manual production will be history, but as I said before, I think there’s a reason that Northwest Bio gives an annual figure for it. And of course cold storage is critical regardless of the manufacturing method. The tumor tissue is shipped and stored in the -20C to -80C range, while the finished doses are cryopreserved and stored in the colder > -194C cryostorage.
I’m not sure if people understand how large the Sawston facility actually is, so I’ll throw some comparability numbers out there. Sawston is roughly double the size of Kite’s 44,000 square foot El Segundo CAR-T manufacturing facility, which Kite estimates is large enough to produce about 4,000 personalized cell therapy treatments annually. The shell size alone shouldn’t be used to compare with potential DCVax manufacturing capability, because this doesn’t account for the difference in manufacturing time or potential space utilization.
It seems reasonable to think that with process optimization using Flaskworks and other automated processes, DCVax-L manufacture time may be reduced from 8 days to 7 days, which is less than half the manufacturing time of Yescarta’s ~16 days. So given that Sawston is double the size and it takes half the time to manufacture DCVax, then theoretically, Sawston should be able to produce 4X Kite’s number, or 16,000 treatments annually using the whole Sawston facility, or the same number of treatments using 1/4 the space. (4,000 treatments using 11,000 square feet) But there’s more.
CAR-T manufacturers use individual all-in-one, end-to-end manufacturing work stations, which isn’t the most efficient use of space, as it ties up each individual work station during the long culturing step. If the Flaskworks system has one culture chamber, then the manufacturing capability would be approximately the same per space utilized. However, with Flaskworks system development, it’s conceivable that, by using larger media fill and waste tanks, and adding additional culture chambers and perfusion pumps, it could produce multiples of that in basically the same footprint. So by adding 10 culture chambers to each system for example, each manufacturing run could produce 10X the number of treatments in basically the same floor space. This might be what Michael Bigger was taking about when he said “cleanroom disruption.”
