• Biomolecules & Therapeutics
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• v.10 no.2
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• pp.129-135
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• 2002

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.

• Korean Journal of Veterinary Research
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• v.43 no.2
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• pp.255-261
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• 2003

The antigenicity of nonspecific immunostimulator BARODON$^{(R)}$, a newly developed drug, was investigated by tests for passive cutaneous anaphylaxis (PCA) and active systemic anaphylaxis (ASA) in mice and guinea pigs. In ASA test using guinea pigs, there were no significant clinical symptoms in all individuals of low(0.3%) and high(3%) dose of both groups treated with only BARODON$^{(R)}$ and cotreated with BARODON$^{(R)}$ and adjuvant group. In PCA test, blue spots of Evan's were observed from $2^6$ to $2^{10}$ in homologous group and from $2^2{\sim}2^5$ dilution rate in heterologous group of BSA treated positive control group. However, intradermal sensitization with antiserum obtained from low (0.3%) and high (3%) dose of BARODON$^{(R)}$ only treatment group and treated-with-adjuvant group, followed by intravenous injection of respective antigen and Evan's blue mixture (1:1) showed no blue spot observed. In conclusion, BARODON$^{(R)}$, as showed in ASA and PCA test, did not cause anaphylatic shock when treated 3 and 10 times higher than clinically intended dose, nor induce IgE, so that might not have antigenic properties in mice and guinea pigs.