Development and validation of an ELISA method for quantification of the anti-HER3 antibody HMBD-001 in human serum: Supplementary figures

Background: HMBD-001 is an IgG1 humanized monoclonal antibody specifically targeting HER3, a receptor

highly expressed on cancer cells in certain tumors. A bioanalytical method was required to quantify HMBD-

001 in human serum, with high selectivity and without interference from HER3. Methods and results: A

bridging ELISA using an anti-idiotypic monoclonal capture and detection was developed and validated

for quantitative measurement of HMBD-001 in human serum. The assay is sensitive, with a lower limit

of quantification of 250 ng/ml, has a broad dynamic range of 250–7000 ng/ml HMBD-001, and exhibits

excellent precision and overall accuracy. Conclusion: We have developed and validated a sensitive and

selective method for measuring HMBD-001 in human serum. This assay is now being used in a clinical trial

setting.