Research Progress on Quantification Methods of Drug Concentration of Monoclonal Antibodies

Abstract

Background: With the development of monoclonal antibodies (mAbs) from the first generation of mice to the fourth generation of human origin, the efficacy and safety in the treatment of many diseases have been continuously improved. MAbs have been widely used in the treatment of cancer, chronic inflammatory diseases, etc. However, the treatment response of mAbs varies greatly among individuals, and drug exposure may be affected by a variety of physiological and pathological factors, such as combined use of drugs and progression of the disease. Therefore, studies tend to recommend therapeutic drug monitoring and individualized treatment strategies. Objective: In this paper, the commonly used methods of quantification of monoclonal antibodies were reviewed, especially liquid chromatography- mass spectrometry (LC-MS/MS) and enzymelinked immunosorbent assay (ELISA), to provide technical support for therapeutic drug detection and individualize dosing for patients. Conclusion: For patients achieving mAbs treatment, it is necessary to carry out therapeutic drug monitoring and take it as a routine monitoring index. We recommend that for pharmaceutical laboratories in hospitals, establishing an appropriate assay format, such as ELISA and LC-MS/MS is critical to determine drug concentration and antidrug antibody (ADA) for mAbs.