International Journal of Biologicals >
Effect of3 IgA removal methodsin humanintravenousimmunoglobulin
Research and Development Center, Hualan Biological Engineering Inc., Xinxiang 453003, China
Online published: 2025-08-16
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.
马力 张学成 范蓓 李光飞 王志刚 周铮 . Effect of3 IgA removal methodsin humanintravenousimmunoglobulin [J]. International Journal of Biologicals, 2022 , 45(1) : 52 -55 . DOI: 10.3760/cma.j.cn311962-20210720-00041
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