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I'm currently providing regulatory support for a client that is manufacturing Drug Substance at multiple CMO sites. The client would like to leverage data across sites to limit the number of studies performed (resin reuse, buffer hold studies, etc.). In particular one question is whether or not they could perform End of Production Cell Bank testing at only one site with the justification that the processes are comparable between sites, with risk assessments for support. Does anyone have any experience and success with this approach? If so any recommendations for success?
Thank you.