[Study on evaluating methods for the quality control of glycoprotein products. (II)--Erythropoietin products. Part 2]

Using recombinant human erythropoietin (rh-EPO) from three different sources, the usefulness of HPAEC-PAD (high-pH anion exchange chromatography with pulsed amperometric detection) for evaluation of carbohydrate moieties of rh-EPO products was evaluated. It is well known that in vivo bioactivity and metabolic fate of EPO are dependent on the number of sialic acids and the degree of branching in the carbohydrate moieties. Here we show that HPAEC analysis reveals differences in the number of sialic acids as well as in the structure of desialylated N-glycans among the rh-EPO products. Therefore, HPAEC is useful for evaluation of the quality of rh-EPO products.