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.
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
