静注人免疫球蛋白中IgA的3种去除方法效果比较

目的    探索滤板压滤法、复合膜法和离子交换层析法对静注人免疫球蛋白中残留IgA的去除效果。方法  对3种过滤方法进行多批次的规模化生产静注人免疫球蛋白中分子大小分布、蛋白回收率和IgA含量的考察，分析不同过滤方法的去除效果。结果  3种过滤方法平均IgA去除率分别为86.6%、92.7%和97.9%；平均蛋白回收率为81.6%、95.3%和97.1%。通过单因素方差分析，发现3种方法并无明显统计学差异。结论  3种过滤方式各有其优缺点，滤板压滤法应用范围管但去除量有限；复合膜法使用方便但成本较高；离子交换层析法分离效果好但审批手续繁琐，不同企业应选择适合自己的过滤方式。

Effect of 3 IgA removal methods in human intravenous immunoglobulin

Objective  To explore IgA removal effects of filter plate, filter membrane, and ion exchange chromatography for human intravenous immunoglobulin.  Methods  Three filtration methods were compared by IgA content, protein recovery rate and distribution of molecular sizes in the large-scale production of multiple batches of human intravenous immunoglobulin and analyze the removal effect of these methods.  Results  The average IgA removal rates of the samples by 3 methods were 86.6%, 92.7%, and 97.9%, and the average protein recovery rates were 81.6%, 95.3 %, and 97.1%. It’s found that the 3 methods had no significant statistical differences by one-way analysis of variance.  Conclusion  Three filtration methods have their own advantages and disadvantages. The application range of the filter plate filter method is limited but the removal amount is limited; The composite membrane method is convenient to use but the cost is high; The ion exchange chromatography method has good separation effect but cumbersome approval procedures. Different companies should choose suit for theirselves.