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  • Title: Overcoming soluble target interference in an anti-therapeutic antibody screening assay for an antibody-drug conjugate therapeutic.
    Author: Carrasco-Triguero M, Mahood C, Milojic-Blair M, Amaya C, Ruppel J, Hong K, Yi JH, Kaur S.
    Journal: Bioanalysis; 2012 Aug; 4(16):2013-26. PubMed ID: 22946917.
    Abstract:
    BACKGROUND: The standard safety evaluation of biotherapeutics includes assessment of immunogenicity. Anti-therapeutic antibodies (ATA) can be detected in serum using immunoassays with a bridging format. However, these assays can be subject to interference. RESULTS: In the bridging ATA assay for 3A5 TDC, an antibody-drug conjugate that binds to the multimeric extracellular domain of MUC16 (CA125), soluble CA125 in the serum caused false-positive results by binding to the ATA assay reagents. This interaction was blocked by wheat germ agglutinin lectin as it binds to the glycans in CA125; thus, the specificity of the assay improved. CONCLUSION: The assay development and validation results showed that the addition of wheat germ agglutinin eliminates the interference from circulating CA125 without impacting the ability to detect ATA.
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