A novel, highly sensitive fluorescent dye–based system for N-glycan analysis
Glycosylation is one of the key critical quality attributes of monoclonal antibody–based biotherapeutics. Glycosylation changes can impact a biological drug’s safety, efficacy, clearance, and immunogenicity, making it necessary to accurately detect changes. Glycan profiling begins at cell line development, continues through process development, and, in certain cases, continues through drug substance release. Current glycan analysis methods involve laborious multistep sample preparation that takes anywhere from a day to multiple days for 96 samples, followed by single-channel LC or CE separation.