LCMS Bioanalysis of Antibody Drugs Using Fabselective Proteolysis "nSMOL Method" - Part 6 - Improvement of Reaction Conditions for Automated Analyses -

Introduction

nSMOL is a new bioanalysis technology developed by Shimadzu Corporation that enables selective proteolysis of the Fab region of monoclonal antibodies. This technology facilitates method development independent of the variety of the antibody drug and is an innovative technology for the bioanalysis of antibody drugs. Furthermore, nSMOL is the only method that has fulfilled the criteria of the "Guideline on Bioanalytical Method Validation in Pharmaceutical Development" (issued by the Japanese Ministry of Health, Labour and Welfare for small molecule drug compounds) with respect to multiple antibody drugs. Shimadzu also offers optimization methods and procedures for each antibody drug. nSMOL method is optimized for use with the Shimadzu LCMS-8050 (hereinafter, LCMS-8050) and LCMS-8060 (hereinafter, LCMS-8060) triple quadrupole mass spectrometers.

August 30, 2018 GMT