整合单通触流过和高性能反流膜净化,以加强单克隆抗体处理
Mirko Minervini1, Aylin Mohammadzadehmarandi1, Ali Behboudi1
1Department of Chemical Engineering, The Pennsylvania State University, Pennsylvania, USA.
Biotechnology and bioengineering
|June 2, 2025
概括
这项研究表明,结合单通触流过 (SPTFF) 和高性能反流膜净化 (HPCMP) 的综合膜工艺,有效地预先条件澄清培养液用于单克隆抗体生产,降低成本.
科学领域:
- 生物技术是生物技术.
- 化学工程是化学工程的重要组成部分.
- 生物加工是一种生物加工.
背景情况:
- 单克隆抗体 (mAbs) 的制造成本是生物制药行业的一个重大问题.
- 强化制造工艺为降低这些成本提供了一条途径.
- 澄清培养液 (CCF) 的高效预制对于下游加工至关重要.
研究的目的:
- 评估用于CCF预先调节的集成膜工艺的性能.
- 评估单通触流过 (SPTFF) 和高性能反流膜净化 (HPCMP) 的组合.
- 为了确定对宿主细胞蛋白 (HCP) 和DNA去除的影响,mAb产量和缓冲器要求.
主要方法:
- 该研究将SPTFF与HPCMP集成为CCF预条件.
- 在24小时内,SPTFF在20倍度系数下运行,没有污染.
- 在缩料上进行HPCMP,然后连续运行36小时.
主要成果:
- 综合流程实现了60%的医疗保健人员减少和超过30倍的DNA删除.
- mAb 的步骤收益率保持在 94%.
- 缓冲器消耗量显著降低至76 L/kg mAb.
结论:
- 集成的SPTFF-HPCMP过程是有效的CCF预先条件在强化mAb制造.
- 这种方法表明,有可能大幅降低制造成本.
- 该过程显示了提高mAb生产经济性的前景.
相关概念视频
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