纳米滤芯过滤静注人免疫球蛋白去病毒工艺的蛋白耗损分析

Analysis of protein loss during removal of virus by Nano filter in production of intravenous immunoglobulin

目的分析使用纳米滤芯过滤静注人免疫球蛋白(intravenous immunoglobulin,IVIG)去除病毒时的蛋白损耗。方法通过分析蓉生静注人免疫球蛋白(pH 4)使用纳米滤芯除病毒过滤前后的蛋白含量,探讨纳米过滤总量、纳米滤芯批号、纳米滤芯数量对纳米滤芯除病毒过程中蛋白损耗量及损耗率的影响。结果纳米过滤蛋白损耗并未随批量增加而增加,使用不同批号滤芯和使用不同数量滤芯进行生产,蛋白损耗变化均较小。结论使用纳米滤芯进行IVIG纳米过滤生产,制品量、滤芯批号及数量对纳米过滤蛋白损耗影响均较小。

Objective To analyze the protein loss during removal of virus by Nano filter in production of intravenous immunoglobulin（IVIG）. Methods The effect of total amount of Nano filter as well as lot number and amount of Nano filter element on protein loss amount and rate during removal of virus in production of IVIG（pH 4） was evaluated by determination of protein contents before and after virus removal by using Nano filter element. Results The protein loss showed no increase with the increasing amount of filtration, while showed no significant difference when the Nano filter elements of differents lot numbers and amounts were used. Conclusion The amount of filtration as well as lot number and amount of Nano filter element showed little effect on protein loss in production of IVIG.