Re-establishment of working seeds and working cell banks using TSE compliant materials - Scientific guideline

HumanScientific guidelines

This document reflects the CPMP/CVMP position on established working seeds (WS) and working cell banks (WCB) that have been declared acceptable with respect to TSE safety. It also provides a guidance for re-establishment of existing WSs and WCBs, which contain materials where not all relevant information is available to demonstrate compliance with the TSE guideline.

Keywords: Transmissible spongiform encephalopathy (TSE), working seeds, working cells banks.

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