Antigenicity of HM10760 in Guinea Pigs

HM10760 is a recombinant human erythropoietin that has beer developed as a drug for anemia. In this study, antigenic potential of HM10760 was examined by active systemic anaphylaxis in guinea pigs and passive cutaneous anaphylaxis in a guinea pig-guinea pig system. HM10760 was subcutaneously administered at 0, 2, and $20{\mu}g/kg$ and also as a suspension with adjuvant ($20{\mu}g/kg$ + FCA). Ovalbumin as a suspension with adjuvant was administered to induce positive control responses. In the active systemic anaphylaxis test, no symptoms except rubbing or licking nose and urination that were considered as physiological phenomena were observed at $0{\mu}g/kg$. Four of 5 animals at $2{\mu}g/kg$ and all the 5 animals at $20{\mu}g/kg$ showed cyanosis and lying on side. All animals in the adjuvant mixture group showed relatively mild symptoms such as rubbing or licking nose, urination, and evacuation. In the passive cutaneous anaphylaxis test, 0/5, 3/5, and 5/5 serum samples from the animals immunized with 0, 2, and $20{\mu}g/kg$, respectively, showed positive reactions against HM10760. All 5 sera collected from the animals immunized with an adjuvant mixture contained HM10760-specific antibodies. These results suggest HM10760 have antigenicity in guinea pigs.