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Genotoxicity Assessment of HM10620 Containing Recombinant Human Interferon-α

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Authors
Kim, Ji-Young; Lee, Young-Mi; Koh, Woo Suk; Kim, Choong-Yong; Choi, In Young; Kwon, Se Chang; Lee, Gwan Sun; Han, Jae Yong; Lee, Michael
Issue Date
2007
Publisher
Taylor & Francis
Citation
Drug and Chemical Toxicology, vol.30 no.1, pp. 83-95
Keywords
Ames assayChromosomal aberration assayGenotoxicityHM10620IFN-αMicronucleus assay
Abstract
HM10620 is a recombinant human interferon-α (rhIFN-α) linked to immunoglobulin via N-terminal–specific non-peptidyl polyethylene glycol linker to improve the in vivo stability of interferon. Potential genotoxic effects of HM10620 in three short-term mutagenicity assays were investigated, which included the Ames assay, in vitro chromosomal aberration assay, and the in vivo micronucleus assay. HM10620 did not cause any mutation in the Ames assay tested using five tester strains at six concentrations of 6.25, 12.5, 25, 50, 100, and 200 μg/plate. To assess clastogenic effect, the in vitro chromosomal aberration assay and the in vivo micronucleus assay were performed using Chinese hamster lung cells and male ICR mice, respectively. Chromosomal aberration was not induced at the concentrations of 10, 20, and 40 μg/mL. Also, there was no difference in the incidence of micronucleated polychromatic erythrocytes at doses of 10, 20, and 40 mg/kg in male mice compared with the vehicle control group. Therefore, based on the results obtained from the three studies, it is concluded that HM10620 is not a mutagenic agent in bacterial cells and causes no chromosomal damage in mammalian cells both in vitro and in vivo.
ISSN
0148-0545
Language
English
URI
https://hdl.handle.net/10371/100238
DOI
https://doi.org/10.1080/01480540601017744
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College of Agriculture and Life Sciences (농업생명과학대학)Dept. of Food and Animal Biotechnology (식품·동물생명공학부)Journal Papers (저널논문_식품·동물생명공학부)
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