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Re: Kaizenman post# 502811

Tuesday, 08/09/2022 9:47:38 AM

Tuesday, August 09, 2022 9:47:38 AM

Post# of 696006
I do not believe this includes DCVax which is an autologous product.

DCVax not a virus either:



Small volume liquids: only cell therapy products; Other aseptically prepared products: manufacture of sterile active substance as part of the continuum processing steps in the manufacture of the finished product: virus specific cytotoxic T lymphocytes; Cell therapy products: virus specific cytotoxic T lymphocytes.



http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do?ctrl=searchGMPCResultControlList&action=Drilldown¶m=149209

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