Removal of polysorbates degradation-related impurities by depth filter screening: A case study

IF 1.8 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Protein expression and purification Pub Date : 2026-05-01 Epub Date: 2026-01-30 DOI:10.1016/j.pep.2026.106893

Chunxiao Xuan , Yangguang Xu , Xinang Cui, Tengfei Ma, Fengjuan Lv

引用次数: 0

Abstract

Depth filtration (DF) is widely utilized as a clarification step in pharmaceutical manufacturing, concurrently removing process-related impurities such as host cell proteins (HCPs) and DNA. This study demonstrates DF's capability in eliminating polysorbates (PS)-degrading impurities (esterases and metals) that may compromise the long-term stability of biopharmaceuticals. By using mass spectrometry-based methods, screening experiments with various commercial depth filters revealed significant brand-dependent variations in impurity removal efficiency. Our findings provide valuable reference data for projects requiring HCP removal, particularly those targeting challenging esterase or metals contaminants.

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深度过滤筛选去除聚山梨酯降解相关杂质：一个案例研究。

深度过滤（DF）被广泛用于制药制造中的澄清步骤，同时去除与工艺相关的杂质，如宿主细胞蛋白（HCPs）和DNA。这项研究证明了DF在消除聚山梨酸酯（PS）降解杂质（酯酶和金属）方面的能力，这些杂质可能会损害生物制药的长期稳定性。通过基于质谱的方法，对各种商用深度过滤器进行筛选实验，发现杂质去除效率存在显著的品牌依赖性。我们的研究结果为需要去除HCP的项目提供了有价值的参考数据，特别是针对具有挑战性的酯酶或金属污染物的项目。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Protein expression and purification 生物-生化研究方法

CiteScore

3.70

自引率

6.20%

发文量

120

审稿时长

32 days

期刊介绍： Protein Expression and Purification is an international journal providing a forum for the dissemination of new information on protein expression, extraction, purification, characterization, and/or applications using conventional biochemical and/or modern molecular biological approaches and methods, which are of broad interest to the field. The journal does not typically publish repetitive examples of protein expression and purification involving standard, well-established, methods. However, exceptions might include studies on important and/or difficult to express and/or purify proteins and/or studies that include extensive protein characterization, which provide new, previously unpublished information.