Gary, I basically agree with your commentary. Though biologics testing has come a long way the past couple of decades making comparisons like this from aseptic processing to Flaskworks automation is mostly about the analytical work which enables the comparison.
Significant variation will always exist in natural occurring biologics compared to mostly synthetic small molecules and the pursuant processing adds variation in specific areas compounded by the variability in the analytical methods themselves. Though the Flaskworks equipment is about as straightforward as a standard 3D printer the process control feedback loops and responses are the keys which have to be proven. And they have to be proven via the use of in house specifically designed and developed analytical methods. This is where the rubber meets the road for equivalency testing. And this is where the RA's have to have confidence in the methods used by the developers of the equipment, the processing and the testing. And it is all based on understanding all the behaviors of the technologies and all the interactions between them, even if each technology utilized is relatively simple.
I believe purchasing the Flaskworks technology and retaining the main system developer as well as building expertise in Sawston (as well I am sure of utilizing outside labs to supplement) and the time that has passed will show they have properly developed the necessary knowledge and development expertise and have created and executed well designed and compliant qualification, validation and equivalency protocols.
This has been an unprecedented long road to product approval but 2023 is finally bringing it through all requirements and obstacles to fruition for the many who will benefit, though it still may have a somewhat deliberate pace.
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