Immunogenicity testing strategy and bioanalytical assays for antibody-drug conjugates.

Hoofring SA, Lopez R, Hock MB, Kaliyaperumal A, Patel SK, Swanson SJ, Chirmule N, Starcevic M.
Journal   Bioanalysis
Analytes Measured  
Matrix Tested   Serum
Year   2013
Volume   5
Page Numbers   1041-1055
Application   Immunogenicity
Background: Immunogenicity testing is an important component of clinical development for large-molecule biotherapeutics. New complex types of large molecules, such as antibody-drug conjugates (ADCs), require careful evaluation of the testing strategy and bioanalytical assays used to monitor the development of antitherapeutic antibodies.

Results: An electrochemiluminescence-based immunoassay for the detection and epitope characterization of anti-ADC antibodies was validated. Using this assay format, antibodies directed against the monoclonal antibody and linker-drug components of the ADC were successfully detected in a multiple-dose rat toxicity study.

Conclusion: Immunogenicity assays incorporating epitope determination may provide additional information about the characteristics of induced antitherapeutic antibodies, including the magnitude and timing of the various types of antibody responses.

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