Hashii Noritaka, Tousaka Yoshiko, Arai Koji, Goda Ryoya, Inoue Noriko, Murata Kazuyuki, Okuzono Takeshi, Sasahara Satomi, Shigeyama Takuma, Tachiki Hidehisa, Yamane Shinichi, Saito Yoshiro, Ishii-Watabe Akiko
Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.
Bioanalysis Department, Advanced Technology Center, Medical Solution Segment, LSI Medience Corp., 30-1, Shimura 3-chome, Itabashi-ku, Tokyo 174-8555, Japan.
Bioanalysis. 2020 Feb;12(4):231-243. doi: 10.4155/bio-2019-0253. Epub 2020 Feb 24.
A generic bioanalytical method was developed to quantify therapeutic IgG1 monoclonal antibodies (mAbs) in mouse sera by combining an easy sample preparation method with LC/MS using selected reaction monitoring. Rituximab and trastuzumab were used as model mAbs. A synthetic stable isotope-labeled peptide or a stable isotope-labeled mAb was used as an internal standard. The method feasibility was evaluated by a collaborative study involving six laboratories. The calibration curve ranged from 1.0 to 1000.0 μg/ml (correlation coefficient >0.99). The validation parameters including selectivity, linearity of calibration curve, accuracy and precision met the predefined acceptance criteria. Our method is a useful bioanalytical method for the quantification of therapeutic IgG mAbs in nonclinical animal studies.
通过将简便的样品制备方法与使用选择反应监测的液相色谱/质谱联用，开发了一种通用的生物分析方法，用于定量小鼠血清中的治疗性IgG1单克隆抗体（mAb）。利妥昔单抗和曲妥珠单抗用作模型单克隆抗体。使用合成的稳定同位素标记肽或稳定同位素标记的单克隆抗体作为内标。通过涉及六个实验室的合作研究评估了该方法的可行性。校准曲线范围为1.0至1000.0μg/ml（相关系数>0.99）。包括选择性、校准曲线线性、准确度和精密度在内的验证参数符合预先定义的验收标准。我们的方法是一种用于非临床动物研究中定量治疗性IgG单克隆抗体的有用生物分析方法。
