Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use - Scientific guideline

This 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.

Keywords: Immunogenicity, monoclonal antibodies, similar biological medicinal products, clinical use, assay strategy

Document history - First version (current)


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