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

IF 1.7 4区化学 Q3 CHEMISTRY, ANALYTICAL Current Analytical Chemistry 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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Abstract

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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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

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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来源期刊

Current Analytical Chemistry 化学-分析化学

CiteScore

4.10

自引率

0.00%

发文量

审稿时长

9 months

期刊介绍： Current Analytical Chemistry publishes full-length/mini reviews and original research articles on the most recent advances in analytical chemistry. All aspects of the field are represented, including analytical methodology, techniques, and instrumentation in both fundamental and applied research topics of interest to the broad readership of the journal. Current Analytical Chemistry strives to serve as an authoritative source of information in analytical chemistry and in related applications such as biochemical analysis, pharmaceutical research, quantitative biological imaging, novel sensors, and nanotechnology.