用于定量检测人血清中单克隆抗体 (mAb) PYX-106 的新型电化学发光 (ECL) 免疫分析法

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-03-28 DOI:10.2174/0115734110293837240320042928

Feng Yin, Diana Adhikari, Xiaodong F. Liu, Jianxin Wang, Wensheng Yang, Gabriela A. Balogh, Teri Simon, Wenji Lei, Mariana Squicciarini, Lisa Bruce, Yan Ke, Mike Dyszel, Shawn Harriman, Jan Pinkas

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引用次数: 0

摘要

背景PYX-106是一种新型单克隆抗体（mAb），其靶点是肿瘤微环境（TME）中的硅铝酸结合免疫球蛋白样凝集素15（Siglec-15）。PYX-106的精确测量对于在临床研究中全面评估PYX-106的药代动力学至关重要。方法开发并验证了一种新型电化学发光（ECL）免疫测定法，用于定量检测人血清中的PYX- 106。采用生物素化的抗PYX-106抗体Bio-A1A1作为捕获抗体，以钌化的抗PYX-106抗体Ru-A3G10作为检测抗体，在中观尺度发现（MSD）平台上进行ECL免疫测定。结果根据2018年美国食品药品管理局（FDA）指南和2022年美国FDA ICH M10指南，该检测方法在选择性、准确性、精密度、钩效应、稳定性等方面得到了充分验证，在人血清中的动态范围为50.0至2,500 ng/mL。结论：：首次报道了PYX-106在生物基质中的生物分析测定验证，该测定已成功应用于支持临床试验PYX-106-101。

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A Novel Electrochemiluminescence (ECL) Immunoassay for the Quantitation of Monoclonal Antibody (mAb) PYX-106 in Human Serum

Background:: PYX-106 is a novel monoclonal antibody (mAb), targeting the sialic acidbinding immunoglobulin-like lectin 15 (Siglec-15) in the Tumor Microenvironment (TME). Precise measurement of PYX-106 is essential for the thorough assessment of PYX-106 pharmacokinetics in clinical investigations. Methods:: A novel Electrochemiluminescence (ECL) immunoassay for the quantitation of PYX- 106 in human serum was developed and validated. Biotinylated anti-PYX-106 antibody Bio-A1A1 was employed as the capture antibody, and ruthenylated anti-PYX-106 antibody Ru-A3G10 was utilized as the detection antibody in the ECL immunoassay on Meso Scale Discovery (MSD) platform. Results:: This assay was fully validated in terms of selectivity, accuracy, precision, hook effect, stability, etc., with a dynamic range from 50.0 to 2,500 ng/mL in human serum under the 2018 U.S. Food and Drug Administration (FDA) guidance and the 2022 U.S. FDA ICH M10 guidance. Conclusion:: PYX-106 bioanalytical assay validation was reported for the first time in a biological matrix, and this assay has been successfully applied to support a clinical trial PYX-106-101.

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.