静注人免疫球蛋白纳米过滤工艺模型的建立

Establishment of nanofiltration process model for intravenous human immunoglobulin

目的探讨纳米膜过滤的最佳实验条件,构建静注人免疫球蛋白的纳米膜过滤工艺模型。方法分析影响纳米膜过滤效率的因素,利用正交实验对纳米膜预过滤系统、制品蛋白质量浓度、pH值、保护剂相关实验参数进行优化。结果选择过滤载量更高的预过滤器。pH值对纳米膜过滤载量影响显著;低蛋白质量浓度条件下,蛋白浓度对过滤载量影响不显著;保护剂对过滤载量影响不显著。预过滤器与纳米膜的最佳面积比为1:1。优化条件下,纳米膜的最大过滤载量达13.6 kg/m^2。结论通过优化工艺组成条件和预过滤可以提高静注人免疫球蛋白过滤载量,进而降低生产过程中纳米膜过滤成本。

Objective To optimize the experimental conditions and construct nanofiltration process model for intravenous human immunoglobulin (IVIG).Methods Factors affecting nanofiltration efficiency,including pre-filter,protein concentration,pH,with/without stabilizer,were analyzed and nanofiltration process model parameters were optimized with orthogonal test.Results The pre-filter system with better filtration load was selected.The nanofiltration efficiency was influenced significantly by pH,but not by protein concentration in low concentration range,or by stabilizer.The optimal area ratio of pre-filter to nano membrane was 1 ∶ 1.Under optimized conditions,the maximal load of nanofiltration was 13.6 kg/m2.Conclusion Optimization of the pre-filter and nanofiltration process model parameters for IVIG can increase the filtration capacity and decrease nanofiltration cost.