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• W2896483963 abstract "In recent studies, the development of bioanalysis technologies using liquid chromatography-tandem mass spectrometry (LC-MS/MS) has attracted attention. Our developed nano-surface and molecular-orientation limited (nSMOL) proteolysis enables Fab-specific proteolysis and is optimal for LC-MS/MS analysis of antibody drugs and Fc-fusion proteins in biological samples. In this nSMOL method, antibodies and Fc-fusion proteins are held in pores of the particle and the subsequent proteolysis is carried out with protease-immobilized nanoparticles. The Fab of antibodies or fused region of Fc-fusion protein can be held to orient toward the reaction solution. The access of the immobilized protease is limited to a part in the structure of protein substrate on the particle surface. Thus, nSMOL proteolysis reacts selectively at the Fab complementarity-determining region of antibodies or N-terminal specific domain of Fc-fusion proteins and can be applied to both types of drugs. We have already evaluated drug concentrations in biological samples pretreated with nSMOL proteolysis using LC-MS/MS for more than twenty drugs, of which ten drugs have been fully validated and published. In this review, we discuss the development and application of LC-MS/MS bioanalysis, which enables the bioanalysis of therapeutic antibodies and Fc-fusion proteins by focusing on a structure-based approach." @default.
• W2896483963 created "2018-10-26" @default.
• W2896483963 creator A5012161779 @default.
• W2896483963 creator A5023330443 @default.
• W2896483963 date "2019-02-01" @default.
• W2896483963 modified "2023-10-18" @default.
• W2896483963 title "Regulated LC-MS/MS bioanalysis technology for therapeutic antibodies and Fc-fusion proteins using structure-indicated approach" @default.
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• W2896483963 doi "https://doi.org/10.1016/j.dmpk.2018.10.002" @default.
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