AI Article Synopsis
- HMBD-001 is a humanized IgG1 monoclonal antibody that targets HER3, a receptor commonly found on certain cancer cells.
- A selective bioanalytical method using a bridging ELISA was created to accurately measure HMBD-001 levels in human serum without interference from HER3.
- This assay is sensitive (with a lower limit of 250 ng/ml), has a wide range (250-7000 ng/ml), and is now being used in clinical trials to quantify HMBD-001.
Article Abstract
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. 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. 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.
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| http://dx.doi.org/10.4155/bio-2022-0141 | DOI Listing |
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