Quantification of serum daratumumab in multiple myeloma patients by LC-MS/MS, comparison with ELISA.

IF 3.1 3区 医学 Q2 CHEMISTRY, ANALYTICAL Journal of pharmaceutical and biomedical analysis Pub Date : 2025-03-15 Epub Date: 2024-12-08 DOI:10.1016/j.jpba.2024.116627
Weiqiang Li, Zhuoran Tian, Xiong Yu, Hongyu Xu, Fang Huang, Jinghua Yu, Xingxing Diao
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Abstract

Daratumumab is a fully human immunoglobulin G1 monoclonal antibody employed for treating relapsed/refractory multiple myeloma and light-chain amyloidosis. Quantifying monoclonal antibodies in serum presents challenges due to interference from biological matrices. This research aimed to develop and verify an liquid chromatography tandem-mass spectrometry (LC-MS/MS) approach for quantifying serum daratumumab, employing immunoglobulin G purification without alkylation, and to assess its applicability in patients with multiple myeloma receiving intravenous daratumumab. The chromatographic peaks of the daratumumab-derived peptides and internal standard were well-delineated from the serum digests, with an overall run time of 14 min. The calibration curves for serum daratumumab were linear across over 1-1000 μg/mL. The inter- and intra-day accuracy varied between 92.4 % and 108.4 %, with a coefficient-of-variation below 10 %. In patients receiving intravenous daratumumab, serum concentrations ranged from 181.8 to 975.3 µg/mL. Bland-Altman analysis revealed no significant bias, and Passing-Bablok regression demonstrated a good agreement between the LC-MS/MS method and enzyme-linked immunosorbent assay.

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用 LC-MS/MS 对多发性骨髓瘤患者的血清达拉单抗进行定量,并与 ELISA 进行比较。
Daratumumab是一种全人免疫球蛋白G1单克隆抗体,用于治疗复发/难治性多发性骨髓瘤和轻链淀粉样变性。由于生物基质的干扰,血清中单克隆抗体的定量提出了挑战。本研究旨在开发和验证一种液相色谱串联质谱(LC-MS/MS)方法,采用免疫球蛋白G纯化而不进行烷基化,用于定量血清达拉图单抗,并评估其在静脉注射达拉图单抗的多发性骨髓瘤患者中的适用性。达拉图单抗衍生肽和内标的色谱峰从血清消化物中被很好地描绘出来,总运行时间为14 min。血清daratumumab的校准曲线在1-1000 μg/mL以上呈线性。日间和日间的准确度在92.4 %和108.4 %之间变化,变异系数低于10 %。在接受静脉注射的患者中,血清浓度范围为181.8至975.3 µg/mL。Bland-Altman分析显示无显著偏倚,Passing-Bablok回归显示LC-MS/MS方法与酶联免疫吸附法之间具有良好的一致性。
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来源期刊
CiteScore
6.70
自引率
5.90%
发文量
588
审稿时长
37 days
期刊介绍: This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.
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