从CHO细胞培养中简化净化复合阿尔法-1抗素,在单个单元操作中使用综合色谱
Zi Ying Zheng1, Wen Qin Tang2, Say Kong Ng2
1Downstream Processing, Bioprocessing Technology Institute (BTI), Agency for Science, Technology and Research (A*STAR), 20 Biopolis Way Centros #06-01, 138668, Singapore.
Journal of chromatography. A
|May 14, 2025
概括
再组合的α-1抗素 (A1AT) 的新净化策略显著提高了纯度,并减少了宿主细胞蛋白质. 这种综合色谱方法为A1AT药物生产的传统方法提供了具有成本效益和高效的替代方案.
科学领域:
- 生物技术是生物技术.
- 蛋白质净化 蛋白质净化
- 生物制药制造业 生物制药制造业
背景情况:
- 来自CHO细胞培养的重组α-1抗素 (A1AT) 是血衍生A1AT的可行替代品.
- 目前的净化方法受到等离子体供应的限制,并且可能是低效的.
研究的目的:
- 开发和优化用于重组A1AT的端到端净化策略.
- 为了达到高纯度和低宿主细胞蛋白水平,与商业药物相比或优于商业药物.
- 为了简化净化过程,降低成本,提高生产率.
主要方法:
- 综合色谱在单个单元操作中结合了2个离子交换色谱 (AEX) 和1个疏水电荷感应色谱 (HCIC) 步骤.
- 优化色谱机制和缓冲条件的优化.
- 与传统的单 AEX 列批量净化方法进行比较.
主要成果:
- 使用综合染色学方法实现了99.9%的纯度和27ppm的宿主细胞蛋白 (HCP).
- 传统方法获得了96.9%的纯度和2860 ppm的HCP.
- 可比较的处理时间和缓冲器消耗,显著改善了产品质量和减少了单位操作.
结论:
- 综合色谱学过程对于净化重组A1AT非常有效.
- 这种简化方法提高了生产率,并可能降低制造成本.
- 开发的方法产生了与商业A1AT产品相比或优于其质量的药物物质.
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