[Study on evaluating methods for the quality control of glycoprotein products. (1). Erythropoietin products].

N Kawasaki, K Morimoto, T Hayakawa
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Abstract

The ability of high performance anion exchange chromatography (HPAEC) with pulsed amperometric detection was studied for evaluation of carbohydrate moieties of erythropoietin (EPO) products. The N-linked oligosaccharides were released from EPO by the treatment with N-glycosidase F. HPAEC analysis of oligosaccharide standards revealed that elution time of sialylated oligosaccharides were dependent on the number of sialic acid, which contributed to the activity of EPO. Using HPAEC, N-linked oligosaccharides of two kinds of recombinant human EPO (rhEPO) produced in chinese hamster ovary (CHO) cells and baby hamster kidney (BHK) cells were compared. The HPAEC profiles of oligosaccharides of these EPO products indicated that there were some differences in the carbohydrate moieties between CHO rh-EPO and BHK rh-EPO. In conclusion, HPAEC method is useful to evaluate the quality of EPO products.

糖蛋白产品质量控制评价方法的研究。(1).促红细胞生成素产品。
研究了高效阴离子交换色谱(HPAEC)与脉冲安培检测法对促红细胞生成素(EPO)产品碳水化合物成分的评价能力。经n -糖苷酶f处理后,n -连接寡糖从EPO中释放出来。寡糖标准品的HPAEC分析表明,唾液酸的洗脱时间与唾液酸的数量有关,唾液酸的数量对EPO的活性有影响。采用HPAEC方法,比较了中国仓鼠卵巢(CHO)细胞和幼鼠肾脏(BHK)细胞中两种重组人EPO (rhEPO)的n -链低聚糖含量。这些EPO产品的低聚糖HPAEC谱表明CHO rh-EPO和BHK rh-EPO的碳水化合物部分存在一定差异。结果表明,HPAEC方法可用于EPO产品的质量评价。
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