Multiplexed immunoassay approach to characterize antidrug antibody like specific reactivity.

Abstract

Aim: Characterization of antidrug antibody (ADA)-like reactivity has emerged as critical element of bioanalytical design and assessment of compound immunogenicity risk. Materials& methods: Multiplex immunoassay was applied to detect and characterize ADA like reactivity using Photonic Ring Immunoassay platform (Genalyte). Specific binding to human IgE or human recombinant IL21-receptor-Fc fusion using exogenous reagents as surrogates for drug-specific reactivity was investigated. Results: Multiplexed assay format allowed identification of spiked antihuman IgE reactivity as murine IgG1 and endogenous antihuman recombinant IL21-receptor-Fc reactivity in rheumatoid arthritis sera as antihuman Fc-specific binding. Conclusion:The ability of a multiplex immunoassay platform to identify isotype and domain specificity of antidrug immunoglobulins was shown to be effective and should be considered when screening and characterizing pre- and post-dose ADA reactivity.