LC-MS Bioanalysis of Antibody Drugs Using Fab-Selective Proteolysis nSMOL - Part 5 - Instrument comparison of precision and accuracy -

Introduction

nSMOL is Shimadzu's completely new and breakthrough LC- MS pretreatment technology 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 achieves a paradigm shift in the bioanalysis of antibody drugs. Furthermore, nSMOL proteolysis 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 protocols for each antibody drug. nSMOL proteolysis is optimized for use with the Shimadzu LCMS-8050 and LCMS- 8060 triple quadrupole mass spectrometers.

May 30, 2018 GMT