LC-MS/MS quantitative method development of Herceptin based on selective hydrolysis (nSMOL) technology and Skyline software

Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. With the wide use of Herceptin in clinic, the requirement is increasing for precision and accuracy in quantitative analysis of Herceptin in human plasma. With the development of high performance liquid phase, mass spectrometry and separation technology in biological samples, LC-MS/MS technology has been used for protein quantity study. Relative to conventional analytical technology ELISA, LC-MS/MS quantitative method improved the precision and accuracy of protein analysis. For the close combination of protein quantitative technology and drug development, Shimadzu combined LC-MS/MS analysis platform and proteomics software "Skyline". And we also developed nSMOL pretreatment technology for selective enzymolysis of Fab zone in monoclonal antibody. Thus, LC-MS/MS combining with Skyline software and nSMOL technology can provide useful tool for the accurate quantity of monoclonal antibody drugs.