Novel Drug and Soluble Target Tolerant Antidrug Antibody Assay for Therapeutic Antibodies Bearing The P329G Mutation | Zendy

Uwe Wessels | Zendy; Eginhard Schick | Zendy; Mirko Ritter | Zendy; Frank Kowalewsky | Zendy; Julia Heinrich | Zendy; Kay Stubenrauch | Zendy

AI Assistant Blog Pricing

Home ZAIA Blog

Open Access

Novel Drug and Soluble Target Tolerant Antidrug Antibody Assay for Therapeutic Antibodies Bearing The P329G Mutation

Author(s) -

Uwe Wessels,

Eginhard Schick,

Mirko Ritter,

Frank Kowalewsky,

Julia Heinrich,

Kay Stubenrauch

Publication year - 2017

Publication title -

bioanalysis

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.566

H-Index - 58

eISSN - 1757-6199

pISSN - 1757-6180

DOI - 10.4155/bio-2017-0048

Subject(s) - antibody , immunogenicity , drug , immunoassay , immune system , microbiology and biotechnology , assay sensitivity , chemistry , monoclonal antibody , pharmacology , biology , immunology , medicine , alternative medicine , pathology

Aim: Bridging immunoassays for detection of antidrug antibodies (ADAs) are typically susceptible to high concentrations of residual drug. Sensitive drug-tolerant assays are, therefore, needed. Materials & methods: 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. Results: 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. Conclusion: Applied in combination with a bridging assay, the novel assay serves as orthogonal assay for immunogenicity assessment and allows further characterization of ADA responses.

The content you want is available to Zendy users.

Already have an account? Click here to sign in.

Having issues? You can contact us here

Accelerating Research