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
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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