Plenty of evidence. It all boils down to having a product that works and has established quality attributes and potency assay. When you have this you can change manufacturing technologies and there is no need to start again. Big problem for CYP as they use 2D manufacturing producing very similar product but have no way of knowing what is critical or not. So you are right when it comes to your manufacturing process, change anything and you are back to the start.
Plenty of evidence. It all boils down to having a product that...
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