dmb, it’s interesting that we can all read the same thing and each come away with different ideas of what is said based upon our own point of view and experience. I wouldn’t have thought that consumables leaching would be an issue until the professor raised it, but it seems likely that some assurances would be a part of the new supplier agreement. I think you’re right, and it makes sense that it would simply be a perfunctory task, particularly if Saint Gobain is the new supplier, since they’re as established as Corning in plastic lab supplies. (note: Saint Gobain supplied the consumable bags for the DCVax-direct trial) This testing would probably be more of an issue for a lesser-known supplier, or if they were selling Flaskworks as a medical device, which the professor didn’t know.
I believe closing and automating processes is more commonly done in conjunction with a marketing application or post approval, but Northwest Bio seems to blaze their own (slower) path, so if I had to guess, right now I would say that Flaskworks approval for investigational products will come before marketing approval, but I agree that it will be interesting to watch how this is unfolds.