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Study on methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion protein
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- Author:
- No author available
- Journal Title:
- ACTA PHARMACEUTICA SINICA
- Issue:
- 3
- DOI:
- 10.3321/j.issn:0513-4870.2003.03.002
- Key Word:
- 重组人肿瘤坏死因子受体-Fc融合蛋白;质控;质量标准;生物学活性
Abstract： 目的建立重组人肿瘤坏死因子受体-Fc融合蛋白质控方法和质量标准.方法用中和TNF-α生物学活性的方法测定重组人肿瘤坏死因子受体-Fc融合蛋白效价,用胰蛋白酶酶切分析肽图,用ELISA方法分别测定蛋白A、残留宿主细胞蛋白残留量和重组人肿瘤坏死因子受体-Fc融合蛋白含量.结果建立了重组人肿瘤坏死因子受体-Fc融合蛋白的生物学活性、肽图分析、残留蛋白A等质控方法和质量标准.结论建立的方法和质量标准已用于重组人肿瘤坏死因子受体-Fc融合蛋白产品的检定.
- [1]饶春明,张翊,韩春梅,等.重组人白细胞介素-11的胰蛋白酶切肽图分析[J].2000,(5).
- [2]Ware JE Jr,Gandek B.Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project.[J].1998,51(11).
- [3]张翊,王军志,郭莹,等.重组人GM-CSF的理化特性及其肽图的研究[J].1998,(2).
- [4]王军志,高凯,饶春明.RHTNF-α生物活性测定方法的改进及其对人白血病早幼粒细胞HL-60作用机理研究[J].1999,(2).
- [5]Craig A. Smith,Terry Farrah,Raymond G. Goodwin.The TNF receptor superfamily of cellular and viral proteins: Activation, costimulation, and death[J].1994,76(6).
- [6]Firestein GS.VIP: a very important protein in arthritis.[J].2001,7(5).
- [7]Feldmann M,Brennan FM,Maini RN.Role of cytokines in rheumatoid arthritis.[J].1996,14.
- [8]K M, Murray,S L, Dahl.Recombinant human tumor necrosis factor receptor (p75) Fc fusion protein (TNFR: Fc) in rheumatoid arthritis.[J].1997,31(11).