生物分析
色谱法
单克隆抗体
肽
化学
校准曲线
单克隆
抗体
医学
检出限
生物化学
免疫学
作者
Noritaka Hashii,Yoshiko Tousaka,Koji Y. Arai,Yoshimasa Enoki,Suguru Fukuda,Ryoya Goda,Noriko Inoue,Mitsuhiko Kawabata,Kazuyuki Murata,Mio Nakatsuji,Takeshi Okuzono,Takuma Shigeyama,Hidehisa Tachiki,Takeru Yamaguchi,Shin‐ichi Yamane,Mariko Yamaoka,Yoshiro Saito,Akiko Ishii‐Watabe
出处
期刊:Bioanalysis
[Newlands Press Ltd]
日期:2021-02-01
卷期号:13 (4): 265-276
被引量:2
标识
DOI:10.4155/bio-2020-0262
摘要
Aim: We aimed to develop an easy, low-cost and versatile mass spectrometric method for the bioanalysis of a therapeutic monoclonal antibody (mAb) in human serum that employs peptide adsorption-controlled (PAC)-LC/MS using selected reaction monitoring mode (LC–MS/MS-SRM). Materials & methods: Rituximab was used as a model mAb. To apply the method to human serum samples, a peptide of the complementarity-determining region was selected as the surrogate peptide. The usefulness of PAC-LC–MS/MS-SRM was evaluated by a collaborative study. Results: The calibration curve ranged from 0.5 (or 1.0) to 1000.0 μg/ml. The selectivity, linearity, accuracy and precision met the predefined acceptance criteria. Conclusion: Our method could be a useful bioanalytical method for the quantification of mAbs in clinical samples.
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