Research progress in quantitative analysis of monoclonal antibody drugs based on mass spectrometry
ZHANG Yan-bao
GAO Hui-tao
ZHENG Xin
HAN Xiao-hong
Abstract：With the continuous development of modern biotechnology,monoclonal antibody,as an important and rapidly growing biotechnology product,plays an increasingly important role in disease treatment,diagnosis and bioscience research.Monoclonal antibodies have been widely used in the treatment of tumors,autoimmune diseases,infectious diseases,and transplant rejection.Although traditional immunoassays are technically straightforward,they are constrained by antibody cross-reactivity,limited dynamic range,and challenges in simultaneously detecting low-abundance monoclonal antibodies and their metabolites within complex biological matrices.In recent years,liquid chromatography-tandem mass spectrometry(LC-MS/MS),as a highly sensitive,highly selective,rapid,and efficient analytical tool,has shown important application value in the analysis of monoclonal antibodies.The purpose of this paper is to review the biological analysis methods of monoclonal antibody,focusing on the detection methods,pre-treatment methods,key steps,and challenges,so as to provide references for further promoting the development of mass spectrometry-based quantitative techniques for monoclonal antibody drugs.
Keywords：monoclonal antibodyLC-MS/MSbioanalysisimmunoadsorbentsample pretreatment method
Publication Date：2026-02-28
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 353-360 )