Released glycan analysis of trastuzumab biosimilar using LCMS-9030

User Benefits

- The methodology for released glycan analysis of trastuzumab biosimilar using LCMS-9030 for sample analysis; and Protein Metrics and SimGlycan software for data processing is described. - Excellent and stable mass accuracy, comprehensive fragmentation pattern and high sensitivity offered by LCMS-9030 helped in identification of N-glycan profile of trastuzumab biosimilar.

Introduction

Monoclonal antibodies (mAbs) are a major class of biopharmaceuticals with indications now covering a large panel of diseases, from cancer to asthma, including central nervous system disorders, infectious diseases and cardiovascular diseases. Glycosylation is a very commonly occurring post- translational modification (PTM) in mAbs, that plays a vital role in the safety and efficacy of many therapeutic mAbs. Throughout therapeutic antibody development, glycosylation analysis is frequently performed not only to profile their biochemical characteristics, but also to assess the stability of expression cell lines and robustness of downstream processes. Furthermore, as an important structural and functional attribute of antibodies and related proteins, glycosylation is a critical aspect in comparing the biosimilar monoclonal antibodies with the innovator’s molecule. This application note describes the methodology for glycosylation profiling of trastuzumab biosimilar at released glycan level using LCMS-9030 for sample analysis and Protein Metrics and SimGlycan software for data processing.

October 29, 2023 GMT