Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BMWP/86289/2010
Published15/06/2012
Effective from01/12/2012
KeywordsImmunogenicity, monoclonal antibodies, similar biological medicinal products, clinical use, assay strategy
DescriptionThis document addresses issues relating to the unwanted immunogenicity of monoclonal antibodies intended for clinical use. It is intended as an addendum to the guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/12/2012–present


Published: 15/06/2012


Published: 26/11/2010


Published: 19/03/2009


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