分泌型rhGM-CSF中试产品的质量分析  

Quality Analysis of Secretory rhGM CSF during pilot fermention and purification process

作　　者：迟春萍[1] 王妍[1] 刘淑玲[1] 张秀霞[1] 刘冬梅[1] 李健平[1] 金铎[1] 李云富[1] 

机构地区：[1]长春生物制品研究所,长春130062

出　　处：《微生物学免疫学进展》2001年第1期37-40,共4页Progress In Microbiology and Immunology

摘　　要：参照 2 0 0 0版《中国生物制品规程》对 3批粒细胞 巨噬细胞集落刺激因子 (rhGM CSF)原液及半成品进行理化及生物学活性检定 ,结果显示 3批rhGM CSF原液及半成品均符合 2 0 0 0版生物制品规程的各项检定标准。对 3批rhGM CSF中试产品质量分析 ,说明rhGM CSF的生产工艺合理 ,产品质量稳定 。The physical and chemical characteritics as well as biological activities of three lots of secretory rhGM CSF were detected during pilot fermentation and purification process,which were from stock solution and semi final products.The results showed that all the quality indexes of three lots confirmed with.Chinese Requiremennts for Biologicals(published 2000).It indicates that the manufacture procedure is well disigned and resonable arranged,and the quality of our prepared rhGM CSF has reached to the standazation for international advanced level.

关 键 词：RHGM-CSF 质量分析 分泌 中试产品 粒细胞-巨噬细胞集落刺激因子 生物制品 

分 类 号：R392-33[医药卫生—免疫学]