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03/30/23 9:27 AM

#581702 RE: hoffmann6383 #581695

hoffman6383,

This certificate includes biological investigational medicinal products 1st and then 1:3:1 biological medicinal products. Appears to be an order to how this process works but I don’t have the last GMPC in front of me to compare. Just noted this as I reread the current cert. I read this before and made the comment that I believed this GMPC basically covers the investigational GMP renewal (not needed yet but also renewed so future inspections are always done together) as well as serves to validate a GMP very for commercial manufacturing. Best wishes.