Please recognize that I know nothing about the specifics of what I'm discussing, I certainly welcome correction, but this is my belief.
I believe that DCVax-L, and many other products, can be made in what I'll refer to as a cell line. Cell lines must be operated in clean room conditions. I know that at places like UCLA, City of Hope, etc. they have cell lines where they do make personalized drugs for patients as necessary.
We know that UCLA does make DCVax-L, and I suspect that many other places given the proper information could do so as well.
I'm saying this because I believe the question of capacity is really not a problem if we have the demand, but it is an expensive proposition. I suspect that CRL alone has tremendous clean room and cell line capacities that they can bring on line for DCVax-L production.
In the long term the Flaskwork device is certainly a far better answer, it doesn't require a clean room at all. I don't know the cost of the disposable cassette, but believe it small when compared with the cost in man hours of working on cell lines. I would suspect that if the cassettes are ordered in tens or hundreds of thousand units the cost per unit will be quite low. As for building the device that the cassette fits in, others have assured me they can be mass produced rather inexpensively. I believe with proper air conditioning surrounding the devices, virtually hundreds of Flaskwork devices can be contained in the space that only a few cell lines would fit into.
If I'm correct, sufficient cell lines currently exist to meet demands, but clearly in the future they'll be replaced by Flaskwork devices. Don't let the fear that we don't have sufficient production capability make you think the regulators won't approve the vaccine, it won't be a problem.
If you believe I'm wrong about this, that existing clean rooms and cell lines can't be adapted to make DCVax-L, please explain to me why not. It's my belief that if DCVax-L became part of the SOC in many solid cancers the demand would be met with a lot of Flaskwork devices, and St. Gobain glasswork will only be too happy to make millions of the disposable cassettes if they're ordered. Corning glass might realize the sale of the company was the biggest mistake they ever made.
Gary
