Quote:
Originally Posted by Sephiroth
Andrew, I don't know what you do for a living. But I live in the world of projects. Risk analysis and risk mitigation are matters of expertise ahead of any feared event. My projects also involve safety of life - and if the vaccine isn't in that class, my whatsit's a kipper.
In the EU vaccine case, one of the feared events is (should be in any competent organisation) late/non-delivery. The EC fupped badly here and then started a campaign to shake the blame off their shoulders,
It's no good you trading nonsense here by looking at the square root of a few words. Nobody agrees with you (that might provoke a few Remainers!).
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There was always going to be a risk in this vaccine project as it uses contract manufacturers such as Halix (as well as others such as Oxford Biomedica and Cobra) Normally, a drug products manufacturing process uses a set suite of equipment. If demand increases, the drug companies are more likely to replicate their factory rather than replacing with a bigger one as it is much, much easier to copy a production process exactly than start messing with things.
This situation is different - each factory will have different equipment. The 'Tech Transfer' process has to take notice of this. If the production process is robust, it will tend to forgive small changes in equipment and processes but I get the impression that the AZ vaccine production process is not really there, it seems finicky. In all honesty, it wouldn't have made it to market in normal times due to this lack of production robustness.
From a regulatory point of view, AZ need to prove that the vaccine produced at a site (in this case Halix) is the same as the one submitted for approval. If the analysis results during production and the final product is different from what was submitted for approval, it is not the same drug and will not be approved. The stage Halix (and Novasep) are at is trying to get to the stage of churning out vaccine that matches the approved product. They can't submit for approval by the EMA until this happens.
Lack of understanding of the production and being in a hurry has led us to where we are now - 'Tech Transfer hell'