원문정보
초록
영어
Glycosylation of biotherapeutics is significantly associated with drug’s quality, safety, and potency. Thus, comprehensive characterization of glycosylation is vital to assess the biotherapeutic quality and establish the equivalency of biosimilars. However, current glycan analysis mainly focuses on the N-glycans due to the absence of analytical tools to liberate O-glycans with high sensitivity. We developed selective and sensitive method to profile native O-glycans on therapeutic glycoproteins. O-glycosylation on biotherapeutics including O-acetylation on a sialic acid was comprehensively characterized. Details such as O-glycan structure and O-acetylmodification site were obtained from tandem MS. This method may be applied to QC and batch analysis of biotherapeutics bearing multiple O-glycosylations.