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Bioanalysis. 2013 May;5(9):1041-55. doi: 10.4155/bio.13.10.

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

Author information

1
Clinical Immunology, Amgen Inc., One Amgen Center Drive, 30E-3-B, Thousand Oaks, CA 91320, USA.

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.

PMID:
23641695
DOI:
10.4155/bio.13.10
[Indexed for MEDLINE]
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