二特异性抗体的下游净化
Qian Li1, Hongyang Zhao1, Xiaoying Liang1
1Nanjing Chia-Tai Tianqing Pharmaceutical Co.Ltd, Fanghua Research Institute, Institute of Biology, Nanjing, 210046, China.
Analytical biochemistry
|October 20, 2024
概括
开发双特异性抗体需要复杂的净化策略来平衡纯度和产量. 本综述详细介绍了捕获这些治疗抗体和去除杂质以进行高效的下游加工的方法.
科学领域:
- 生物技术是生物技术.
- 免疫学 免疫学 免疫学
- 蛋白质化学 蛋白质化学
背景情况:
- 与传统的单一特异性抗体相比,双特异性抗体提供了更高的治疗效果和更少的副作用.
- 它们的复杂结构在下游净化过程中带来了重大挑战.
- 实现高纯度和产量对于双特异抗体的临床应用至关重要.
研究的目的:
- 系统地审查和概述净化双特异抗体的策略.
- 为优化双特异抗体生产下游流程提供指导.
- 为了应对在双特异抗体制造中去除杂质和最大化产量的挑战.
主要方法:
- 对两种特异性抗体捕获的既定和新兴技术的审查.
- 分析消除与产品相关的杂质 (如聚合物,碎片) 的方法.
- 讨论减轻过程相关杂质 (例如宿主细胞蛋白,DNA) 的策略.
主要成果:
- 确定双特异抗体净化的关键色谱步骤.
- 评估不同的亲和性联结体和多模式色谱,以去除杂质.
- 在生产过程中控制和减少具有挑战性的杂质的形成的策略.
结论:
- 两种特异性抗体的有效净化需要多步骤的方法来平衡纯度和生产力.
- 精心选择净化策略对于最大化产量和确保产品质量至关重要.
- 本次审查为开发双特异抗体疗法强大的下游流程提供了框架.
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