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Comparison Study on the Critical Quality Attributes between Similar Biological Medicine(YD057) and Dulaglutide

??OBJECTIVE To investigate whether there is significant difference between the GLP-1-Fc fusion protein(YD057) that is expressed by gene recombination and the marketed drug dulaglutide(Lilly). METHODS SDS-PAGE, SEC, CE-SDS and CIEF were used to analyze the differences in molecular weight, purity and charge heterogeneity. The amino acid sequence, biological activity and receptor binding analysis were measured to assess whether the cytological function and molecular binding capacity were consistent. Oligosaccharide distribution was measured to assess whether N-linked glycosylation modification ratio was consistent. RESULTS There was no significant difference in physicochemical properties, amino acid primary sequence, N-linked glycosylation modification ratio, cell biology function and receptor binding capacity between the biological similar drugs(YD057) and dulaglutide. CONCLUSION Their critical quality attributes are basically the same.