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中国仓鼠卵巢(CHO)细胞—基本药物的病毒安全性已很好确证。已有1亿次以上输注CHO衍生的药物未证实病毒传染的单独病例。重组因子Ⅸ(rFⅨ)的生产建立在这样的安全记录之上,通过采用一种接近病毒安全性的多层次工艺状态。这些包括广泛测试用于生产rFⅨ的CHO细胞,细胞培养生产过程的常规病毒监控,工业生产和配方不采用血液或血浆制品以及验证纯化过程的病毒去除能力。rFⅨ的多方面病毒安全性计划
The virus safety of Chinese hamster ovary (CHO) cells - essential drugs has been well established. More than 100 million transfusions of CHO-derived drugs have not confirmed individual cases of viral infection. The production of recombinant factor IX (rFIX) is based on the safety record by adopting a multi-level process state close to virus safety. These include extensive testing of CHO cells used for the production of rFIX, routine virus monitoring of cell culture production processes, absence of blood or plasma preparations for industrial production and formulation, and validation of the virus removal capabilities of the purification process. Multifaceted virus safety program for rFIX