Replies to post #405518 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Advent doesn’t get a “license”, as has been explained numerous times, the facility is GMP, in London. Advent is hired as the CDMO for NWBO at that facility for making DCVax. There is no special “license”. The production there was GMP Certified. Advent is the responsible manufacturer and I presume as I have said before that that means they were previously certified at that facility as well. It is facility specific. Which is why they needed to have a certification at Sawston. They are still certified compliant in the London facility as well and will be so long as they continue to operate there. And this is why their role is completely modular, and why the contracts allow for the CDMO to be replaced. All the IP belongs to NWBO, and they are hired by contract. At Sawston, the facilities and inputs all belong to NWBO, other than the Human Resources, which are provided by contract. The manufacturer is the certified compliant party because they are the responsible party if something goes wrong and procedures were not followed and a batch is deemed or production series is deemed adulterated.