Shimadzu Review Vol.74[1・2](2017)


Feasibility study of therapeutic drug monitoring for biopharmaceuticals by mass spectrometry

by Noriko Iwamoto, Ph.D.1and Takashi Shimada, Ph.D.1

Shimadzu Review 74[1・2] (2017.6)


After two decades from first approved monoclonal antibody drug, many excellent antibodies have been approved in severe drug discovery. In 2015, global market size of antibody drugs is above 700 billion USD, and this will be forecasted to increase. Antibody drugs have been actively treated because of its high-specificity to target molecules and low adverse effect. However, indicator development for clinical efficacy of antibody therapy has been delayed. In 2000s, clinical relevance between efficacy and blood level has been revealed by several antibody trials. Therefore, the importance of antibody level in blood are now discussing for one of the indicators of drug efficacy. In this report, we will discuss the analytical technology for therapeutic drug monitoring (TDM) using nSMOL (nano-surface and molecularorientation limited proteolysis、Iwamoto N, Analyst, 2014) coupled with LCMS bioanalysis.

Keywords: Antibody drug, nSMOL, LCMS, Therapeutic drug monitoring, Multiplex assay, Regulatory science

1Technology Research Laboratory, Shimadzu Corporation, Kyoto, Japan

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