治疗类制品专题

不同过滤条件对去除血浆组分Ⅱ溶解液中IgA的效果初探

  • 曹璟 叶璇 陈蓓 潘立新 刘怡俊 许周敏 徐路
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  • 国药集团上海血液制品有限公司血液制剂室 200051;3M中国有限公司研发部,上海 200233

网络出版日期: 2025-08-16

Preliminary study on the effect of different filtration conditions on the removal of IgA from plasma fraction Ⅱ dissolving solution#br#

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  • Blood Preparation Department, Sinopharm Shanghai Plasma-derived Biotherapies Co., Ltd., Shanghai 200051, China; Department of Research and Development,3M China Co., Ltd., Shanghai 200233, China

Online published: 2025-08-16

摘要

目的  初步筛选去除血浆组分II溶解液中IgA效果最佳的pH条件和滤膜载量。方法  以不同pH组分Ⅱ溶解液进行过滤,比较浊度、IgA含量、分子大小分布、纯度。结果 pH7.25~7.90,滤膜载量300~400 L/m2,组分Ⅱ溶解液经滤膜组合过滤后滤液浊度下降45.8%~60.5%、IgA含量下降68.0%~80.0%、分子大小分布为100%、纯度为100%。结论  组分Ⅱ溶解液在pH7.25~7.90,载量≤400 L/m2条件下,经滤膜过滤后不仅能有效去除IgA,而且其他质量指标保持不变,可为规模化生产工艺改进提供参考。

本文引用格式

曹璟 叶璇 陈蓓 潘立新 刘怡俊 许周敏 徐路 . 不同过滤条件对去除血浆组分Ⅱ溶解液中IgA的效果初探[J]. 国际生物制品学杂志, 2021 , 44(1) : 48 -51 . DOI: 10.3760/cma.j.cn311962-20200702-00071

Abstract

Objective  To preliminarily screen pH conditions and filter capacity with optimal effect on the removal of IgA from component Ⅱ dissolving solution. Methods  The dissolving solutions of component II with different pH were used for filtration, and the turbidity, IgA content, molecular size distribution and purity were compared. Results  The dissolution solution of component II at pH7.25-7.90, and filter capacity is 300-400 L/m2, after filtering through filter combination the filtrate turbidity decreased by 45.8%-60.5%, the IgA content decreased by 68.0%-80.0%, the molecular size distribution was 100%,and the purity was 100%. Conclusion  Under the condition of pH7.25-7.90 and filter capacity ≤400 L/m2, after filtering through the filter membrane, not only can IgA be effectively removed, but also other quality indicators remain stable. It can provide reference for the improvement of large-scale production process.
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