Comparison Study on the Critical Quality Attributes between Similar Biological Medicine(YD057) and Dulaglutide
DAI Ya-dong, PENG Hong-wei, GOU Fan-cheng, HOU Yi-ling, DING Xiang*
Key Laboratory of Southwest China Wildlife Resources Conservation(Ministry of Education), College of Life Science, China West Normal University, Nanchong, Sichuan 637009, China
Abstract��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.
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DAI Ya-dong, PENG Hong-wei, GOU Fan-cheng, HOU Yi-ling, DING Xiang. Comparison Study on the Critical Quality Attributes between Similar Biological Medicine(YD057) and Dulaglutide. Chinese Pharmaceutical Journal, 2018, 53(4): 300-305.
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2018, Vol. 53 
