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2013
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Immunogenicity testing strategy and bioanalytical assays for antibody-drug conjugates.
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.
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Journal
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Bioanalysis
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Species
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Analytes Measured
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Matrix Tested
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Serum
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Abstract
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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