Comparison of Primary Structures of Recombinant Human Erythropoietin Marketed in China
TAO Lei, LI Xiang, ZHOU Yong, QIN Xi, RAO Chun-ming*
National Institute for Food and Drug Control, Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing 100050, China
Abstract��OBJECTIVE To characterize and compare the primary structures of recombinant human erythropoietin marketed in China.METHODS Recombinant human erythropoietin reference substances were obtained from nine manufacturers, for which the molecular mass, peptide mass mapping, oligosaccharide profile and content of sialic acid were analyzed and compared. RESULTS The measured molecular masses of de-N-glycosylated EPO were all in agreement with the theoretical values with mass error less than 1. All the samples had consistent amino acid sequence, disulfide bonds (Cys7-Cys161, Cys29-Cys33), O-glycosylation site (Ser126), and N-glycosylation sites (Asn24, Asn38, Asn83), but different glycosylation pattern and ratio of glycoforms. The sialic acid content of the nine samples were within 11.5-15.7 mol��mol EPO. CONCLUSION Recombinant human erythropoietins from nine manufacturers have identical primary structures except for glycosylation patterns.
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TAO Lei, LI Xiang, ZHOU Yong, QIN Xi, RAO Chun-ming. Comparison of Primary Structures of Recombinant Human Erythropoietin Marketed in China. Chinese Pharmaceutical Journal, 2016, 51(13): 1071-1075.
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