Quality of biological active substances produced by transgene expression in animals

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Current effective versionAdopted guideline
Reference numberCHMP/BWP/151897/2013
Published10/06/2013
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Superseded documentAdopted guidelineDates in operation: 31/06/1995–01/12/2013


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