ATLnsider, I think there’s many ways to guesstimate the potential production capacity for Flaskworks automation, so until we get more information, it’s really anyone’s guess, and you could be right. Our estimates were really not that far apart using different methods, but that 16,000 number that I threw out was just theoretic, and I wasn’t trying to be accurate at this point because there are too many unknowns. Perhaps my post was a long winded way of saying that I think Sawston is a relatively large facility, with plenty of capacity for Advent to manufacture DCVax for both the UK and EU, and as flipper said, there’s also room for Advent to manufacture for other clients using the high-grade clean rooms, that for the most part, Northwest Bio won’t require. Plus, there’s potentially a way to scale it to the masses when that time comes.
I’ve seen that 10X manual process capacity estimate here before, and to be honest, I don’t know where it came from. Is that taken from Corning’s brochure for the Flaskworks’ MicroDEN system? That it’s supposedly 10X more efficient or something, so somehow it will have 10X the production capacity? I personally don’t think that’s a useful way to analyze Flaskworks potential production capacity because the open manual processes, workflows, and clean room requirements are so different than for the automated, closed processes.
The automated workflow manufacturing process for CAR-T’s is much more similar to the automated workflow process that I think DCVax will have. The first step for both is cell isolation, (with CAR-T’s, the T-cells are separated from the other cells in the leukapheresis material instead of the dendritic cells) and although the CAR-T’s go through an extra process of engineering the T-cells, but the DCVax dendritic cells don’t, otherwise the rest of the manufacturing process involves culturing, washing, filling into dosing containers, and cryopreserving, which is all fairly similar. So, because it's an established autologous cell therapy, that will likely use a similar closed, automated production process as DCVax, it seems (to me) to be a more tangible way to compare and estimate.
To be realistic though, and put these projections into perspective; it’s been almost 5 years since Yescarta was approved, and Kite is still only producing at half of that projected capacity level. Although I anticipate that DCVax will ramp much more quickly than Yescarta, it’s still an expensive, brand-new cell therapy treatment with insurance reimbursement hurdles, complicated logistics, and new hospital protocols to establish, etc., so even though I project that potential capacity, I think the ability to manufacture DCVax in these larger quantities may not be as necessary as rapidly as many here seem to expect.
