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有效的宿主细胞蛋白质清除:对生物制药过程中的膜吸附剂和树脂的研究

Ernest Šprager¹, Veronika Reisinger², Jonas Sommer²

¹University of Ljubljana, Faculty of Pharmacy, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia; Novartis Technical Research & Development, Novartis Pharmaceutical Manufacturing LLC, Kolodvorska 27, 1234 Mengeš, Slovenia.

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

|September 20, 2025

概括

膜吸附剂为单克隆抗体提供有效的净化,显著减少宿主细胞蛋白 (HCP). 3MTM Polisher ST混合净化器在简化生物工艺和提高生产率方面表现有前途.

科学领域:

生物制药净化生物制药净化
膜技术膜技术膜技术
下游加工下游加工

背景情况:

生物制药净化越来越倾向于生产性和成本效益的方法.
膜技术为传统树脂的净化提供了一个可行的替代方案.
这项研究评估了用于单克隆抗体净化的离子交换介质.

研究的目的:

将三种离子交换介质的杂质去除效率进行比较.
调查宿主细胞蛋白 (HCP) 和聚合物去除.
评估基于膜的设备在过程简化方面的潜力.

主要方法:

实验设计 (DoE) 优化pH值,离子强度和负载密度.
评估四级氨基功能化的树脂,纤维素膜吸附剂和混合净化器.
高通量酶测定和液体染色学-双重质谱学用于HCP分析.
突破性的实验来评估媒体的稳定性.

主要成果:

基于膜的设备显示出高的杂质去除能力.
3MTM Polisher ST将HCP水平从8000 ppm降低到10 ppm.
需要使用正交的分析方法,因为雌激酶的存在与一般的HCP趋势有所不同.
单独的阳离子交换色谱对聚合物清除不够,需要额外的抛光步骤.

结论:

3MTM Polisher ST混合净化器显示了简化净化过程的巨大潜力.
膜技术为生物制药净化提供了灵活和高效的替代方案.
进一步的直角抛光步骤对于全面去除杂质至关重要,特别是对于聚合物.

关键词:

聚合物聚合物聚合物阳离子交换色谱学阳离子交换色谱学设计实验的设计.宿主细胞蛋白质是宿主细胞的蛋白质.膜吸附剂是一种膜吸附剂.聚酸盐的降解降解

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