Quality of biological active substances produced by transgene expression in animals

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Current effective versionAdopted guideline
Reference numberCHMP/BWP/151897/2013
Effective from01/12/2013
KeywordsTransgenic animals, recombinant protein, matrix
DescriptionThis 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

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/12/2013–present

Published: 10/06/2013

Published: 31/05/2012

Published: 20/05/2009

Superseded documentAdopted guidelineDates in operation: 31/06/1995–01/12/2013

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