Thanks biosectinvestor, I’ve seen that first link before and flipper beat me to the reply. I’ve posted links to that Invetech site as well to show what the next version of the Flaskworks device might look like. I agree that there are many different methods and commercial equipment available to perform the manufacturing functions, and that some of Advent’s commercial manufacturing development work likely was completed before Sawston licensing.
I’ve been told that I write in a dogmatic style sometimes and I can’t deny it, but I assure you that I welcome differing opinions and points of view. I was pushing back on the narrative that Flaskworks certification has been completed, which has been repeated multiple times, by multiple posters, but all without plausible explanation, and an understanding of everything that Advent has been working on. Perhaps people confuse the actual comparability study, with the practice runs, which are steps to interface with the Autolomous softtware and sensors, and dial in the Flaskworks system to Northwest Bio’s culturing and maturation protocols, which can be, and likely was, accomplished before licensing.
It is my belief that the Flaskworks comparability study will be a side-by-side comparison, manual culturing method vs automated Flaskworks method, which requires real patients, and that has to be conducted in a licensed GMP facility. The length of time for the actual study will obviously depend on how long it takes to get the compassionate-use patients in the study, and the number of batches required. You don’t want to see much variation between each Flaskworks’ batch, so if there is wide variation, then more will have to be run. At this point it’s really anyones guess how long that will take, but mine is after the second quarter. The second quarter may be the optimistic goal, which is fine, but I don’t have remind anyone about Northwest Bio’s optimistic timelines around here.
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