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