治疗性单克隆抗体的药物监测:LC-MS/MS技术的应用进展

Therapeutic drug monitoring for monoclonal antibody:progress in the application of LC-MS/MS technique

随着生物制剂的迅猛发展,治疗性单克隆抗体以其低毒高效的优点占据临床治疗的重要地位,临床疗效的个体差异对开展抗体药物的常规治疗药物监测提出了新的需求。因此,建立准确、可靠的分析方法定量测定单克隆抗体,对于其临床应用至关重要。近年来LC-MS/MS技术在大分子药物中的应用越来越广泛。本文综述了LC-MS/MS技术在单克隆抗体定量分析中的应用、常见问题及解决办法等,为治疗性单克隆抗体的临床治疗药物监测提供技术支撑。

With the rapid development of biopharmaceuticals,therapeutic monoclonal antibodies(mAbs)are widely accepted due to their low side-effects and high therapeutic efficacy.Individual differences in the response to mAb drugs put forward new requirements for therapeutic drug monitoring of antibody drugs.Therefore,the need for accurate and robust bioanalytical methods is increasing.Recently,LC-MS/MS has been gaining increasing interest in the field of large molecules.In this article,the recent advances in this emerging field are reviewed,along with common issues and analytical approaches.Thus,this review article is helpful for better understanding the advance of LC-MS/MS technique in the field of therapeutic drug monitoring for mAbs.