Doubling capacity when you're only looking to reach a few hundred patients in a Phase 3 trial is a drop in the bucket when compared to the demand for an approved product. In 2012 I have no idea if they envisioned a device like the FlaskWorks Eden unit for making DCVax-L, but once they learned of it they made a great move in acquiring the company.
The cost of creating tens of thousand of individual cleanrooms for producing DCVax-L would be a huge multiple of the cost of making it in larger facilities with tens of thousands of Eden units, that's clearly driving the decision not to go for worldwide approval until the Eden unit is approved. I believe they'll go for it in the U.K. with minimal capacity with manual manufacturing, and they're waiting for approval of that facility.
I believe that if DNDN had a device similar to the Eden for production of Provenge the company would probably be thriving today, instead of going belly up. NWBO could probably survive on manual production of the vaccine, but it will be very costly to produce, the extra time needed to gain approval of the Eden unit should allow them to thrive, and DCVax-L's pricing should be determined acceptable throughout the world.
Anyone following NWBO knows that they're using contractors to develop things like the BLA's, I believe they're essentially done and where rolling submissions are permitted, they've been made. Clearly you cannot submit until you're prepared to produce commercial quantities in an inspected and approved facility. I can't say whether Sawston totally outfitted with Eden units can meet worldwide demand, but the CRL facility in Memphis appears to be fit out to take the Eden units as well, though no formal agreement exists for CRL to take on that production, but it was acknowledged in the Annual Meeting. I believe you'll see a formal agreement with CRL once the Eden unit's been approved by the regulators. Mass producing the Eden units and their disposable cassettes shouldn't be a problem once the unit has regulatory acceptance.
Gary