Eliminating drug target interference with specific antibody or its F(ab')₂ fragment in the bridging immunogenicity assay.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS Bioanalysis Pub Date : 2024-04-01 Epub Date: 2024-02-22 DOI:10.4155/bio-2023-0191

Xiaojie Deng, Yingying Hou, Wenyi Yuan, Hongzhou Yang, Ruowen Guo, Tingting Liu, Yongzhen Liu, Junjiu Xu, Heng Liu, Likun Gong, Qiuping Qin

引用次数: 0

Abstract

Background: DB-1003 is a humanized anti-IgE monoclonal antibody with higher affinity than omalizumab. In the affinity capture elution (ACE)-based bridging electrochemiluminescent immunoassay (ECLIA) for antibodies to DB-1003, monkey serum IgE caused false-positive results. Materials & methods: The target-specific antibody or its F(ab')₂ fragment was used to mitigate drug target interference in an ACE-based bridging ECLIA for the detection of anti-DB-1003 antibodies. Results: The sensitivity of the developed assay was at least 100 ng/ml. When the anti-drug antibody concentration was 250 ng/ml, the assay tolerated at least 20.0 μg/ml of the monkey IgE. Conclusion: Incorporating the target-specific antibody or its F(ab')₂ fragment can overcome the interference from monkey serum IgE in ACE-based bridging ECLIA for anti-DB-1003 antibody detection.

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消除桥接免疫原性试验中特异性抗体或其 F(ab')2 片段对药物靶点的干扰。

背景介绍DB-1003 是一种人源化抗 IgE 单克隆抗体，其亲和力高于奥马珠单抗。在基于亲和力捕获洗脱（ACE）的桥接电化学发光免疫测定（ECLIA）中检测 DB-1003 的抗体时，猴子血清 IgE 会导致假阳性结果。材料与方法：用目标特异性抗体或其 F(ab')2 片段来减轻基于 ACE 的桥接电化学发光免疫分析仪检测抗 DB-1003 抗体时的药物目标干扰。结果所开发检测方法的灵敏度至少为 100 ng/ml。当 ADA 浓度为 250 ng/ml 时，该检测方法可耐受至少 20.0 μg/ml 的猴 IgE。结论在基于 ACE 的桥接 ECLIA 检测抗DB-1003 抗体时，加入目标特异性抗体或其 F(ab')2 片段可以克服猴血清 IgE 的干扰。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.

Eliminating drug target interference with specific antibody or its F(ab')2 fragment in the bridging immunogenicity assay.

Abstract

Eliminating drug target interference with specific antibody or its F(ab')₂ fragment in the bridging immunogenicity assay.