천연형 인성장호르몬 DA-3002 의 항원성 = Antigenicity of DA-3002 , a Genuine Recombinant Human Growth Hormone , in Guinea Pigs and Mice

다국어 초록 (Multilingual Abstract)

DA-3002 is a genuine human growth hormone produced by Dong-A Pharm. Co. Ltd. research laboratory using recombinant DNA technic. In this study, antigenic potential of DA-3002 was examined by active systemic anaphyaxis(ASA) in guinea pigs, mouse-rat passive cutaneous anaphylaxis(PCA) and passive hemagglutination(PHA) test as a part of safety research. DA-3002 induced anaphylactic shock in ASA test using guinea pigs immunized with DA-3002 alone or DA-3002 incoporated into Freund`s complete adjuvant(FCA) when challenged with 10 times higher dose of anticipated clinical dose of DA-3002, In the mouse-rat PCA and PHA test, DA-3002 also showed positive results. DA-3002, therfore, was considered to produce IgE, IgG and/or IgM in mice. The results of this study were similar to those of the other human growth hormones and these positive results were thought to be caused due to the fact that both DA-3002 and the other human growth hormones were heterogenous proteins to guinea pigs and mice. Considering the fact that DA-3002 is a genuine human growth hormone of which structure is identical with indigenous human growth hormone, DA-3002 is thought not to cause immunological problems in clinical use.