哺乳动物细胞在生物技术药物研究与开发中的应用

Application on Mammalian Cells in Research and Development of Biopharmaceuticals

分析了20多年来欧美已上市的生物技术药物,指出哺乳动物细胞已成为生物技术药物研发主要采用的基因表达系统。对外源基因高表达工程细胞株、高效工程细胞培养工艺、工程细胞产物分离纯化技术及工程细胞制品的安全性评价等进行了综述分析,并论述了中国哺乳动物细胞工程化技术现状和在药物研发中的作用。

The licensed biopharmaeeutieals in U.S.A. and E.U. in last two decades have been reviewed in this paper.The authors pointed out that the gene expression system of mammalian cells has become major system in research and development of biopharmaeeuticals the progresses in construction of foreign gene high expressed engineered cell line was discussed, in process for large scale fermentation of mammalian cells and in safety evaluation of the products from mammalian cells. The authors also described the progress of biopharmaeeuticals produced with mammalian cell system in China.