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

文献类型：期刊论文

作者Li, Weiqiang1,2; Tian, Zhuoran1,3; Yu, Xiong1,5; Xu, Hongyu1,5; Huang, Fang4; Yu, Jinghua1; Diao, Xingxing1,2
刊名JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
出版日期2025-03-15
卷号255页码:7
关键词Multiple myeloma Daratumumab LC-MS/MS Surrogate peptide
ISSN号0731-7085
DOI10.1016/j.jpba.2024.116627
通讯作者Huang, Fang(huangfang335@163.com) ; Yu, Jinghua(yujinghua2@simm.ac.cn) ; Diao, Xingxing(xxdiao@simm.ac.cn)
英文摘要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 daratumumabderived 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 mu g/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 mu g/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.
WOS关键词DEXAMETHASONE
WOS研究方向Chemistry ; Pharmacology & Pharmacy
语种英语
WOS记录号WOS:001386311800001
出版者ELSEVIER
源URL[http://119.78.100.183/handle/2S10ELR8/315294]  
专题中国科学院上海药物研究所
通讯作者Huang, Fang; Yu, Jinghua; Diao, Xingxing
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, Shanghai 201210, Peoples R China
2.Univ Chinese Acad Sci, Beijing 100049, Peoples R China
3.Tianjin Univ Tradit Chinese Med, Inst Tradit Chinese Med, Tianjin 301617, Peoples R China
4.Shanghai Jiao Tong Univ, Xinhua Hosp, Sch Med, Dept Hematol, Shanghai 200092, Peoples R China
5.Ocean Univ China, Sch Med & Pharm, Qingdao 266003, Peoples R China
推荐引用方式
GB/T 7714		 Li, Weiqiang,Tian, Zhuoran,Yu, Xiong,et al. Quantification of serum daratumumab in multiple myeloma patients by LC-MS/MS, comparison with ELISA[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2025,255:7.
APA Li, Weiqiang.,Tian, Zhuoran.,Yu, Xiong.,Xu, Hongyu.,Huang, Fang.,...&Diao, Xingxing.(2025).Quantification of serum daratumumab in multiple myeloma patients by LC-MS/MS, comparison with ELISA.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,255,7.
MLA Li, Weiqiang,et al."Quantification of serum daratumumab in multiple myeloma patients by LC-MS/MS, comparison with ELISA".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 255(2025):7.

入库方式： OAI收割

来源：上海药物研究所

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