Immunogenicity assessment of biotechnology-derived therapeutic proteins

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMEA/CHMP/BMWP/14327/2006
Published13/12/2007
Effective from01/04/2008
KeywordsImmunogenicity, unwanted immune response, biotechnology derived proteins, immunogenicity risk factors, assays, clinical efficacy and safety, risk management
DescriptionThis document contains background information concerning the potential causes and impacts of immunogenicity of biological/biotechnology-derived proteins. It provides general recommendations for the performance of a systematic immunogenicity assessment from a marketing authorisation perspective.


Document history

Revision 1

Adopted guideline
 

Draft guideline


Concept paper

Published: 01/06/2017
Effective from: 01/12/2017
 

Published: 01/10/2015


Published: 25/03/2014

First version

Current version

Adopted guideline


Draft guideline


Concept paper

In operation: 01/11/2010–present


Published: 24/01/2007


Published: 22/02/2006


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