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

Oladipo S Idowu1, Jenny L Craigen2, Gareth J Veal1

  • 1Newcastle University Centre for Cancer, Newcastle University, Newcastle upon Tyne, NE2 4HH, UK.

Bioanalysis
|November 15, 2022
PubMed

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.

Keywords:
ELISAHER3assay validationcancerpharmacokinetics

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