Peptide Mapping of Monoclonal Antibody (mAb) Using Nexera Bio with Q-TOF Mass Spectrometer for Full Sequence Confirmation

Introduction

The manufacturing of antibody drugs has been gaining massive popularity due to their specificity towards target diseases, efficacy and role as potential personalised medicines. Peptide mapping plays a critical role in quality assurance of antibody drugs. It is employed for elucidating of the primary structure of antibody biosimilars. Peptide mapping of enzymatic digest is carried out using a C18 reversed phase column on a inner HPLC or UHPLC. In this report, a biocompatible Nexera Bio UHPLC system is evaluated in terms of repeatability of LC profiling analysis of tryptic digest of human IgG (immunoglobulin G). It is then applied to bevacizumab biosimilar, a recombinant monoclonal IgG1 antibody. Subsequently, LCMS-9030 (Q-TOF) was employed for confirming the protein sequence through accurate mass matching analysis of the peptides detected, which provides comprehensive and reliable structural characterization and sequence information of the biosimilar drug.

December 6, 2019 GMT