A competitive ligand-binding assay to detect neutralizing antibodies to a bispecific drug using a used multiplex Meso Scale Discovery platform

Background: Monitoring appearance of neutralizing antibodies (NAbs) to multidomain large molecule drugs is a challenging task. Materials & methods: Here, we report development of a competitive ligand-binding assay for detection of NAbs to a bispecific candidate drug using a used multiplex Meso Scale Discovery platform, which allows for detection of NAbs to both drug arms in the same sample. Results: The assay has sensitivity better than 250 ng/ml and is tolerant to the presence of drug at concentration >600 mu g/ml and to the level of soluble target(s) >400 ng/ml. Conclusion: Our data suggest that multiplex approach can be successfully used for development of NAb assays in competitive ligand-binding assay format.

Automated summary

The study developed a competitive ligand-binding assay for detecting NAbs to a bispecific candidate drug, which showed sensitivity better than 250 ng/ml and tolerance to high concentrations of drug and soluble targets. The data suggest that a multiplex approach can be successfully used for developing NAb assays in competitive ligand-binding assay format.