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exwannabe

09/20/25 1:47 PM

#789101 RE: bas2020 #789099

au contraire... it's why S87 was developed by the MHRA. You should really pay attention to the developments.


I admit I do not always keep up with the latest developments from the fantasy AI world.

S87 allows for a centralized QA plan and qualified person and makes GMP certification simpler. It does not change the fact that this entire concept of POS mfg for -L is replicating a lot of Sawston at every hospital. A huge expense and for no benefit.

Under your concept every site will need (at a minimum):

1) The initial processing of the leuko-pak.
2) The freeze thaw cycles used to extract the lysate
3) The Eden device and operational support
4) The fill and finish equipment
5) The cryostorage
6) The post batch production lab work (which is not part of Eden as you falsely assert).,

That would be hugely expensive if done POS. Even with Eden.

And for what benefit? The patient does not use the first dose for a month or more later.

Sure, GM could manufacture cars at dealerships to save on shipping too.