Quality of biological active substances produced by transgene expression in animals

Current effective version PDF iconAdopted guideline
Reference number CHMP/BWP/151897/2013
Published 10/06/2013
Effective from 01/12/2013
Keywords Transgenic animals, recombinant protein, matrix
Description This document addresses the use of transgenic animals as a manufacturing technology for the production of recombinant therapeutic proteins. Guidance is provided on the approaches that should be employed in order to achieve satisfactory quality for biological active substances to be produced using this technology.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

In operation: 01/12/2013–present


Published: 10/06/2013


Published: 31/05/2012


Published: 20/05/2009

Superseded document PDF iconAdopted guideline Dates in operation: 31/06/1995–01/12/2013

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