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når der anvendes celleseeds, skal det dokumenteres, at celleegenskaberne er uændrede op til det højeste antal passager, der er anvendt ved fremstillingen.
when cell seeds are used, the cell characteristics shall be shown to have remained unchanged up to the highest passage level used for the production.
Last Update: 2014-11-21
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når der anvendes cellebanker, skal det dokumenteres, at celleegenskaberne er uændrede efter det antal passager, der er anvendt ved fremstillingen og derudover.
when cell banks are used, the cell characteristics shall be shown to have remained unchanged at the passage level used for the production and beyond.