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

被引：3
|
作者：
Idowu, Oladipo S. [1 ]
Craigen, Jenny L. [2 ]
Veal, Gareth J. [1 ]
Jamieson, David [1 ]
机构：
[1] Newcastle Univ, Newcastle Univ Ctr Canc, Newcastle Upon Tyne NE2 4HH, England
[2] Canc Res UK Ctr Drug Dev, London E20 1JQ, England
来源：
BIOANALYSIS | 2022年 / 14卷 / 18期
关键词：
assay validation; cancer; ELISA; HER3; pharmacokinetics; RECEPTOR HETERODIMERIZATION; ERBB3; EXPRESSION; GROWTH; CANCER; HER3;
D O I：
10.4155/bio-2022-0141
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
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.
引用
收藏
页码：1241 / 1249
页数：9
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