An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug

Monoclonal antibody therapeutics typically have relatively long half-lives and can be dosed at high levels. Although formation of anti-drug antibodies (ADA) is relatively rare, detection of these antibodies can be very difficult in the presence of high circulating levels of drug. Typically these ADA...

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Bibliographic Details
Published in:Journal of immunological methods 2007-10, Vol.327 (1), p.10-17
Main Authors: Bourdage, James S., Cook, Carolyn A., Farrington, Daphne L., Chain, Jana S., Konrad, Robert J.
Format: Article
Language:English
Subjects:
Acid dissociation
Antibodies - analysis
Antibodies - immunology
Antibodies, Anti-Idiotypic - immunology
Antibodies, Monoclonal - immunology
Antibodies, Monoclonal - therapeutic use
Antibody Affinity
Antibody assay
Antibody Specificity
Antigen interference
Biological and medical sciences
ELISA
Enzyme-Linked Immunosorbent Assay - methods
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Humans
Immunoassay - methods
Immunogenicity
Molecular immunology
Sensitivity and Specificity
Techniques
Therapeutic proteins
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Summary:Monoclonal antibody therapeutics typically have relatively long half-lives and can be dosed at high levels. Although formation of anti-drug antibodies (ADA) is relatively rare, detection of these antibodies can be very difficult in the presence of high circulating levels of drug. Typically these ADA are detected by bridging ELISAs which can be very sensitive to even low levels of drug. We describe an ELISA method based on affinity capture of ADA on solid-phase drug followed by removal of excess free drug, release and transfer of bound ADA and subsequent detection using biotinylated drug. The assay is both sensitive and highly tolerant to free drug with detection of 500 ng/ml of ADA readily achieved in the presence of 500 μg/ml of drug.
ISSN:0022-1759
1872-7905
DOI:10.1016/j.jim.2007.07.004