Draft guideline on quality of biological active substances produced by transgene expression in animals

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Download document Draft guideline on quality of biological active substances produced by transgene expression in animals
Reference number EMA/CHMP/BWP/159188/2012
Status draft: consultation closed
First published 31/05/2012
Last updated 31/05/2012

Summary

This guideline provides guidance on the approaches that should be employed in order to achieve satisfactory quality for biological drug substances proposed to be produced using transgenic animal technology. Its principal aim is to adapt some specific aspects of the quality guidance already in place for other recombinant production systems to the special case of transgenic animal systems.