Electrospray Ionization Quadrupole Ion-Mobility Time-of-Flight Mass Spectrometry as a Tool to Distinguish the Lot-to-Lot Heterogeneity in N-Glycosylation Profile of the Therapeutic Monoclonal Antibody Trastuzumab

摘要

Monoclonal antibodies (MABs) are an upcoming group of disease-modifying drugs. Their efficacy results from specificity and inhibition of the target antigen and from biological activities (effector functions) activated by immune complexes formed. MABs are used to treat cancer, auto-immune diseases, and systemic infections [1]. Trastuzumab (Herceptin) is a humanized monoclonal immunoglobulin -1 (IgG1) antibody directed against the HER2eu receptor, which is over-expressed in about 25% of all breast cancer patients [2, 3].