Novel drug and soluble target tolerant antidrug antibody assay for therapeutic antibodies bearing the P329G mutation

Bioanalysis
Uwe WesselsKay Stubenrauch

Abstract

Bridging immunoassays for detection of antidrug antibodies (ADAs) are typically susceptible to high concentrations of residual drug. Sensitive drug-tolerant assays are, therefore, needed. An immune complex assay to detect ADAs against therapeutic antibodies bearing Pro329Gly mutation was established. The assay uses antibodies specific for the Pro329Gly mutation for capture and human soluble Fcγ receptor for detection. When compared with a bridging assay, the new assay showed similar precision, high sensitivity to IgG1 ADA and dramatically improved drug tolerance. However, it was not able to detect early (IgM-based) immune responses. Applied in combination with a bridging assay, the novel assay serves as orthogonal assay for immunogenicity assessment and allows further characterization of ADA responses.

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Citations

Sep 11, 2019·Protein Engineering, Design & Selection : PEDS·Diana DarowskiChristian Klein
Mar 12, 2021·Cytometry. Part a : the Journal of the International Society for Analytical Cytology·Fabian JunkerHenry Kao

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Methods Mentioned

BETA
ELISA
chip
surface plasmon resonance
Assay

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