影响人血白蛋白Fv过滤时间的工艺研究

Process Research on the Filtration Time of Fv in Human Albumin

在利用压滤技术分离Fv时,时常会出现过滤时间长,Fv沉淀中液体含量高及沉淀冻存到温时间长的情况。经研究发现,上述情况主要受Fv制作时缓冲液添加速度及过滤时压滤机进液压强的影响。在其他工艺参数不变的情况下,改变缓冲液加液速度及进液压强。经多批次生产统计发现,在平均加液速度为36L/h及进液压强为160k Pa时,能大幅缩短过滤时长,减少沉淀中液体含量,缩短沉淀冻存到温时间。此工艺对缩短生产周期,降低能耗有重要意义。

During filtering Fv with pressure filtration technique, if the filter time is too long, Fv precipitations with high liquid content and the precipitations freeze-stored to the specified temperature with a long time happen frequently.The study found that those were influenced by the speed of adding buffer in manufacturing Fv and the liquid inlet pressure. In the case of other parameters constant, the speed of adding buffer and the liquid inlet pressure were changed. The statistics with multi-batch of production showed that it could reduce the filtration time, the liquid content of precipitations and the time of precipitations freeze-stored to the specified temperature with the speed of adding buffer 36.0L/h and the liquid inlet pressure 160 k Pa. It has an important significance to reduce production time and energy consumption.