Lykiri, of course I agree with you “that the changes to the manufacturing of the ATMP must be supported by the data generated in a comparability exercise.“ However when you say “IMO, this is valid for both investigational ATMPs and authorised ATMPs,” are you saying that you think that only a comparability exercise for the Flaskworks system is all that’s needed for commercialization? If so, you’re probably in good company, but I think we may be reading into some information differently.
The way that I read the quote that you highlighted from the Arnold and Porter Blog is that it’s saying that the data from a comparability exercise for an investigational product should show evidence that the post-change investigational product is equivalent to the pre-change investigational product, and the data from the comparability study for a commercial product should show evidence that the post-change commercial product is equivalent to the pre-change commercial product. There are different GMP for investigational products than for commercial products, so the comparability exercise for each type of product should comply with the GMP for that type of product.
I don’t think a comparability study alone will provide sufficient evidence for regulators to conclude that an investigational product is equivalent to a commercial product, and it will require additional process validation and development documentation, which may or may not be occurring simultaneously. It makes sense to me to do this all at the same time for expediency, but there’s always unknown factors that may make expediency less of a priority.
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