Quote:
Originally Posted by Sephiroth
The EC project delivery manager would have the knowledge of how to do a risk analysis. They did have a project manager, didn't they?
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The issue is that often, you don't know how hard or easy the tech transfer will be until you do it. When the contracts were signed off in mid August, the manufacturing process was still in development. Even going from lab scale to large scale at one manufacturing site is fraught with issues. This process has gone from Oxford Uni to AZ development to Cobra and Oxford Biomedica to pin down the production method. Cobra and Oxford Biomedica had the freedom to tinker about with the production to get it going well. Halix, Novasep, CSL,
etc. don't have such a luxury.
There was a lot of risk signing off the contract in August and the contract acknowledges that risk. Hell, there was no idea if the vaccine would even work at that point!
It is known what step is causing the problems. How to fix it is the struggle and that is down to AZ, the manufacture and the supplier of the manufacturer to sort