피부각질세포치료제에 적합한 순도시험법 연구
분야
의약학 > 의공학
저자
이수연 ( Su Yeon Lee ) , 박선화 ( Seon Hwa Park ) , 채병철 ( Byung Chul Chae ) , 김선희 ( Sun Hee Kim ) , 박순희 ( Sue Nie Park ) , 김윤영 ( Yun Young Kim )
발행기관
한국조직공학·재생의학회
간행물정보
조직공학과 재생의학 2010년, 제7권 제4호, 452~459페이지(총8페이지)
파일형식
2a800565.pdf [무료 PDF 뷰어 다운로드]
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    영문초록
    Many keratinocyte therapy products are in development or have recently been introduced onto the market. Recently new products are constantly produced and approved for clinical use in burn surgery and other chronic wounds. The purpose of this study is to suggest the purity test method for keratinocyte therapy products. In this study, we investigated the cellular impurity test and in-process impurity test for keratinocyte therapy products. For cellular impurity test, the ratio of inactive cell (fibroblast, endothelial cell and melanocyte) to against active cell was detected using real-time PCR and FACS (fluorescent activated cell sorter). Because of unavailability of specific surface marker, cellular impurity results by real-time PCR was more objective than FACS. For in-process impurity test, the amount of residue gentamicin and FBS were detected. A sensitive and robust high-performance liquid chromatographic method with fluorescence detection (HPLC-FLD) was developed for the determination of gentamicin residues in keratinocyte therapy product. Gentamicin is consists of four major components, C1, C1a, C2, and C2a. BSA (bovine serum albumin) residues of FBS were detected by commercial test kit based on ELISA (Enzyme-Linked Immunosorbent Assay).
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