method for detection of monoclonal antibody using mass spectrometry

摘要

The present invention provides a process for easier detection and quantitation of a protein by regioselectively digesting a variable region of a fab domain of a monoclonal antibody while proteolysis of an fc domain is suppressed. In the process, a porous body in which a monoclonal antibody is immobilized on pores and nanoparticles on which a protease is immobilized are contacted with each other in a liquid to perform selective proteolysis of the monoclonal antibody and a resulting peptide fragment is detected using liquid chromatography-mass spectrometry (1c-ms) and a peptide having an amino acid sequence that includes an amino acid derived from a cdr2 region of a heavy chain or a light chain of the monoclonal antibody is detected.