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재조합 사람성장호르몬(소바트로핀)의 KFDA표준품(KS 98/674) 설정연구
신원(Won Shin),정지원(Jee Won Joung),진재호(Jae Ho Jin),Adrian F. Bristow,손여원(Yeo Won Sohn) 대한약학회 2001 약학회지 Vol.45 No.2
The complexity and variability of both the biologicals and the bioassays used to test them led to the use of the reference standard- a sample of the product of defined purity and potency, against which all preparations of that product must be calibrated. In order to prepare and establish KFDA reference standard for recombinant human growth hormone(somatropin), somatropin substance was filled in ampoules in National Institute for Biological Standards and Control(NIBSC). The candidate KFDA reference standard for somatropin(designated as 98/674) was evaluated to determine the suitability of serving as a KFDA reference standard for somatropin by the collaborative study, in which 10 laboratories participated. Physicochemical analysis and in vivo bioassay were performed by direct comparison with the international somatropin standard 88/624. 98/674 was identified as somatropin by SDS-PAGE, IEF, peptide mapping, and HPLC. Determination of somatropin content by SE-HPLC yielded a mean estimate of 2.01mg somatropin per ampoule. Data from the study also yielded mean values of 0.39+/-0.26% for high molecular weight impurities by SE-HPLC and mean values of 2.13 +/- 1.29 % for somatropin related proteins by RP-HPLC. Estimates of relative potency by weight gain bioassay in the hypophysectomised rats showed that relative potency of KS 98/674 was 1.07 against IS 88/624. Based on the results of the collaborative study, the candidate reference standard for somatropin is suitable to serve as a KFDA reference standard for somatropin.
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손여원,신원,정자영,최영주,정지원,오일웅,진재호,박선영,박태성 식품의약품안전청 2000 식품의약품안전청 연보 Vol.4 No.-
우리나라에서 유통되고 있는 재조합 인터페론 알파의 역가시험을 표준화하기 위하여 국내제조 5개사,수입 1개사 및 식품의약품안전청이 참여하여 공동연구를 실시하였다. 공동연구 참여사의 역가시험법의 상대적인 감도와 상용표준품의 활성을 비교 ·보정하기 위하여 공통의 인터페론 알파 시험물질에 대하여 5회 이상의 독립적인 시험들 실시하고 시험결과의 정확도, 정밀포 및 재현성을 비교하였다. 보다 정확한 분석을 위하여 모든 참여사는 자사 제품의 품질관리에 적용되고 있는 역가시험법과 더불어 식품의약품안전청에서 제공한 참조씨험법을 함께 시험하였고 시험결과를 자사의 계산법과 동시에 평행선분석법으로 각각 계산하여 그 차이를 비교하였다. 그 결과 시험의 정밀도와 재현성은 각 참여사의 자사 뵉가시험법과 평행선분석법을 적용하였을 째 보다 우수하게 나타났고 대부븐의 참여사에서 1표시역가의 80%~l%', 신뢰구간 '표시울가의 64%~l56%' 내에 분포하여 상대적인 감도가 고르면서 정확포가 높았다. 또한 각 참여사의 자사 결과계산법과 평행선분석법 간의 차이를 't-Test'로 분석한 결과 유의한 차이를 나타내지 않았으며 모든 찹여사의 두 가지 시험법과 분석법으로부터 얻은 평균값들의 차이를 분석한 결과 유의한 차이를 나타내지 않아 모든 참여사의 인터페론 역가시헌이 '표준화'되어 있는 것으로 분석되었으며 평행선분석법 및 신뢰구간에 대한 적용가능성을 제시하였다. The specific activiw of recombinant interferons made by different manufacturers can vary and bioassay systems which are utilized to determine the biological potency ofinterferon may he affected by a number of factors, such as ceIB lines, viruses and the statisticalanalysis of the assay. Tllerefore the bioassay of interferon, like as other biological products, isessentially comparative and thus requires a fHxed reference standard and standardized assayconditions. A collaborative study was performed for standardization of interferon bloassay. Sixlaboratories of interferon Danufacturers and KFDA were participated in this study. Alllaboratories measured the potency of'the same inteferon samples'by their own routinemethods and the reference method which was offered by KFBA. The results were analysed byboth ways using their own data analysis methods and the usual statistical methods for aparallel line assay The relatiue sensitivities of each assay system and the potency of eachworking standard of the participants were compared by assessing the assay performance svchas accuracy, precision and reproducibility. The results showed best pr·ecision and reproducibiBitywhen the potency was measured by the manufacturer's routine methods and calculated byparallel line analysis. Tte estimated potency was from 80% to 125% and the confidence limitwas from 64% to 156% of the stated potency in most laboratofes, which showed goodaccuracy. Differences in data analysis between the manufacturer's routine analytical method andthe Parallel line assay were not significant by't-Test'and differences in all results fromroutine assay and reference assay also were not significant by'analysis of valiance'. Based onthe results of the collaboriltive study, all participants were'standardized'in the interferonbioassay and we may consider the change of the data analysis of Inteferon potency to thestatistical method for a parallel line assay.
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