Interesting thought, coordinating changes across sites and countries is no small challenge. And, since each country regulatory body has to approve any changes your point is an interesting possibility. I thought the hold was at all sites thereby removing the possibility of having a single country issue. But, it is possible they need a minimum enrolled in Germany. I would say mfg is not the cause of the hold, though it is not impossible to be so. The carriers who transport cold chain product have to validate their containers and their routes using those containers. This has been a booming part of the biologics industry and it is not so difficult these days to contract with dependable transporters as the big boys of transportation have entered the space too.
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