Antigenicity of HM10411 in Guinea Pigs

기니픽에서 HM10411의 항원성

  • 고우석 (한국화학연구원 부설 안전성평가 연구소) ;
  • 김종춘 (한국화학연구원 부설 안전성평가 연구소) ;
  • 차신우 (한국화학연구원 부설 안전성평가 연구소) ;
  • 김영민 (한미약품(주) 중앙연구소) ;
  • 정성엽 (한미약품(주) 중앙연구소) ;
  • 권세창 (한미약품(주) 중앙연구소) ;
  • 이관순 (한미약품(주) 중앙연구소)
  • Published : 2002.06.01

Abstract

HM10411 is a recombinant granulocyte-colony stimulating factor (rG-CSF) that has been developing as a drug for neutropenia. In this study, antigenic potential of HM10411 was examined by active systemic anaphylaxis (ASA) in guinea pigs and passive cutaneous anaphylaxis (PCA) in guinea pig-guinea pig system. HM10411 was subcutaneously administered at 0,5, and 50 mg/kg and also as a suspension with adjuvant (50 mg/kg+FCA). Ovalbumin (OVA) as a suspension with adjuvant was used to induce positive control responses. In the ASA test, no symptoms except urination and evacuation that were considered as physiological phenomena were observed at 0 and 5 mg/kg. Two of 5 animals at 50 mg/kg showed sneering, dyspnea, or cyanosis. All animals in the adjuvant mixture group showed severe symptoms of anaphylatic shock and 3 of them died. In the PCA test, no antibody against HM 10411 was detected in the sera from the animals sensitized with 0 or 5 mg/kg. Only 1 serum sample from the animals immunized with 50 mg/kg showed positive reaction against HM10411, while all 5 sera collected from the HM10411 and FCA mixture group contained the HM10411-specific antibodies. These results suggest HM10411 is considered to have antigenicity In guinea pig.

Keywords

References

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