重组人粒细胞集落刺激因子-Fc融合蛋白(rhG-CSF-Fc)的质量研究
Quality control research of recombinant human granulocyte colony-stimulating factor-Fc fusion protein(rhG-CSF-Fc)
分类号：
出版年·卷·期（页码）：2012,32 (1):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的: 建立重组人粒细胞集落刺激因子-Fc融合蛋白的质控方法和质量标准。方法: 采用NSF-60细胞增殖法测定生物学活性;非还原SDS-PAGE电泳和RP-HPLC测定纯度;以ELISA法分别测定残留CHO细胞蛋白和蛋白A;其余检测项目按中国药典2010年版三部规定进行。结果: 用建立的方法对重组人粒细胞集落刺激因子-Fc融合蛋白原液和成品进行了检定,各项指标均符合《人用重组DNA制品质量控制技术指导原则》和中国药典2010年版三部的要求。结论: 建立的质控方法和质量标准具有保证产品安全有效、质量可控的特点,可用于该类产品的常规检定。
-----英文摘要：---------------------------------------------------------------------------------------
Abstract Objective: To establish methods and requirements for quality control of recombinant human granulocyte colony-stimulating factor-Fc fusion protein(rhG-CSF-Fc). Methods: Biological activity of rhG-CSF-Fc was determined by NFS-60 cell proliferation assay. Non reducing SDS-PAGE and RP-HPLC were applied to analyze the product purity. CHO host cell protein and Protein A residue were determined by ELISA. Routine tests were all carried out according to Pharmacopoeia of Peoples Republic of China(volume Ⅲ,2010 edition). Results: The requirements and methods for quality control of rhG-CSF-Fc were established and used for quality control of bulk and final product. The results of all tests complied with the requirements of Guideline for Quality Control of Recombinant DNA Products for Human Use and Pharmacopoeia of People’s Republic of China (volume Ⅲ,2010 edition). Conclusion: The methods and requirements for quality control of rhG-CSF-Fc showed characteristics of assuring the products safety and efficacy,which can be used for routine quality control rhG-CSF-Fc.
-----参考文献：---------------------------------------------------------------------------------------
1 Lyman GH,Shayne M.Granulocyte colony-stimulating factors:finding the right indication.Curr Opin Oncol,2007,19(4):299
2 Kamar N,Abravanel F,Garrouste C,et al.Three-month pegylated interferon-alpha-2a therapy for chronic hepatitis E virus infection in a haemodialysis patient.Nephrol Dial Transplant,2010,25(8):2792
3 Silva LC,Ortigosa LC,Benard G.Anti-TNF-α agents in the treatment of immune-mediated inflammatory diseases:mechanisms of action and pitfalls.Immunotherapy,2010,2(6):817
4 ChP(中国药典).2010.Vol Ⅲ(三部):附录(Appendix)72,56
5 YAO Xue-jing(姚雪静),LI Zhuang-lin(李壮林),FANG Jian-min(房健民).Peptide mapping analysis of recombinant human B lymphocyte stimulator receptor:IgG Fc fusion protein(重组人B淋巴细胞刺激因子受体-抗体融合蛋白的肽图分析).Chin J Pharm Anal(药物分析杂志),2011,31(6):1185
6 ZHOU Hai-jun(周海钧).Bioassay for Pharmaceuticals(药品生物检定).Beijing(北京):People’s Medical Publishing House(人民卫生出版社),2005.385
7 WANG Jun-zhi(王军志).Development and Quality Control of Biopharmaceuticals(生物技术药物研究开发和质量控制).Beijing(北京):Science Press(科学出版社),2007.76
欢迎阅读《药物分析杂志》！您是该文第 2013位读者！
