NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Smokey, I don’t think it has to do with Flaskworks per se, but is consistent with a commercial process. GMP for an investigational product only requires final-product testing, and initially, it appears that Advent outsourced their final-product sterility testing, which normally takes a couple of weeks. This would make economical sense in the limited quantities they were sending out, but would make less sense for larger quantities of a commercial operation. In-house sterility testing would also be important for in-process testing that is required for the validated commercial process.