국내 허가된 유전자재조합의약품 품질시험에 사용되는 전하변이체 분석법 조사연구

Analysis on approval documents of recombinant DNA-derived biopharmaceuticals (172 items) marketed inKorea showed as followed. First of all, antibody drugs are about 37% among the biopharmaceuticals and most ofantibodies as a major ingredient (about 92%) are humanized or human type. Second, charge variant assays using in quality(purity) test are distinctly different between antibody drugs and non-antibody drugs. The former prefer CEX and cIEF, thelatter IEF and CZE. The preference difference may be related to size and complexity of target molecules. Third, the resultof analysis on usage of 4 assays (CEX, CZE, IEF, and cIEF) in accordance with approval period indicated that cIEF usagegot increased since 2010 and was about 50% after 2015. And finally, acceptance criteria of charge variant assays showeda few distinguished patterns independent of drug products. In the light of these facts, whether or not to establish a chargevariant method and acceptance criteria as a quality test, and which method to use may depend on the characteristics ofthe product and analysis conditions of other manufacturers. In particular, in biopharmaceuticals that contain polymerproteins as the main component, such as antibodies, charge variant analysis is important, and the use of modern analyticalmethods such as the icIEF method is expected to increase. KCI Citation Count: 0