{Reference Type}: Journal Article
{Title}: Mitigating target interference challenges in bridging immunogenicity assay to detect anti-tocilizumab antibodies.
{Author}: Bhavaraju K;Dhiman MK;Desai H;Brien KO;Gadgil SS;Mohapatra S;Kumar V;
{Journal}: Bioanalysis
{Volume}: 16
{Issue}: 12
{Year}: 2024 Jul 16
{Factor}: 2.695
{DOI}: 10.1080/17576180.2024.2349417
{Abstract}: Aim: An assay to detect anti-tocilizumab antibodies in the presence of high levels of circulating target and drug is needed for immunogenicity assessment in comparative clinical studies.Methods: An assay was developed and validated using a combination of blocking agents and dilutions to overcome target interference challenges.Results: No false-positive signal was detected in serum samples spiked with 350-500 ng/ml of IL-6 receptor. As low as 50 ng/ml of positive control antibodies could be detected in the presence of either 500 ng/ml of IL-6 or 250 μg/ml of the drug product. Assay also demonstrated high sensitivity, selectivity and precision.Conclusion: A robust, easy to perform immunogenicity assay was developed and validated for detecting anti-tocilizumab antibodies.<BR>[Box: see text].