이은주 (충남대학교)

윤소희 (한국표준과학연구원)

박해민 (충남대학교)

이은주 (충남대학교)

윤소희 (한국표준과학연구원)

박해민 (충남대학교)

Glycosylation profiling and quantitative analysis are essential for assessing biosimilarity and quality attributes of biopharmaceuticals. Matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) has been widely adopted as a powerful analytical tool for glycan profiling, owing to its high ionization efficiency for glycans and predominant formation of singly charged ions. In this study, we introduce a rapid and streamlined glycomics strategy that combines stable isotope labeling of N-glycans using a cationic reagent with an amidation reaction of sialic acids. This approach enables simultaneous relative quantification of both neutral and sialylated N-glycans within a MALDI-MS spectrum. Linearity and reproducibility of the method were evaluated using N-glycans released from human serum IgG. Subsequently, application to an originator biologic and its biosimilar demonstrated effective relative quantification and confirmed practical utility in biopharmaceutical analysis. Thus, this method effectively differentiates glycosylation patterns resulting from manufacturing variability and serves as a rapid and practical tool for biosimilar quality control in biopharmaceutical development.

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