通过深度过器选去除与聚酸盐降解相关的杂质:一个案例研究
Chunxiao Xuan1, Yangguang Xu1, Xinang Cui1
1Downstream Process Development (DSPD), WuXi Biologics (Shanghai FX), Building No.1, 1150 Lan Feng Road, Feng Xian District, Shanghai, 201403, China.
Protein expression and purification
|February 1, 2026
概括
深度过有效地去除诸如宿主细胞蛋白 (HCP),DNA,酶和金属等杂质. 过器品牌对去除效率产生重大影响,为生物制药制造提供了宝贵的数据.
科学领域:
- 生物制药制造业 生物制药制造业
- 过技术过技术的使用
- 分析化学 分析化学
背景情况:
- 深度过 (DF) 是生物制药生产中的关键澄清步骤.
- DF可以去除与过程相关的杂质,如宿主细胞蛋白 (HCP) 和DNA.
- 聚酸盐 (PS) 可能因酶和金属而降解,影响药物的稳定性.
研究的目的:
- 评估深度过在去除PS降解杂质 (乙酸和金属) 的有效性.
- 评估不同深度过器品牌对杂质去除效率的影响.
- 为特定的杂质去除需求提供支持深度过器选择的数据.
主要方法:
- 使用各种商业深度过器进行选实验.
- 基于质谱的杂质定量分析方法.
- 评估不同的过器品牌的杂质去除.
主要成果:
- 深度过证明了它能够去除降解聚酸盐的雌激酶和金属.
- 在不同深度过器品牌之间观察到污染物去除效率的显著差异.
- 质谱仪证实了目标杂质的存在和去除.
结论:
- 深度过不仅可以有效地去除HCP和DNA,还可以有效地去除关键的聚酸盐降解杂质.
- 深度过器的选择至关重要,因为特定品牌的性能差异很大.
- 该研究为优化澄清过程和确保生物制药稳定性提供了必要的数据.
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