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相关概念视频

Affinity Chromatography01:03

Affinity Chromatography

Affinity chromatography is a powerful technique extensively utilized for separating and purifying specific biomolecules from complex mixtures. It capitalizes on the highly selective binding between an analyte and its counterpart, such as antibody-antigen interactions. The counterpart is immobilized on the stationary phase, forming an affinity column. The stationary phase typically consists of solid support, such as agarose or porous glass beads, immobilizing the affinity ligand. The mobile...

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相关实验视频

Updated: Jun 7, 2026

Isolation and Characterization Of Chimeric Human Fc-expressing Proteins Using Protein A Membrane Adsorbers And A Streamlined Workflow
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从一个封闭连接的单一用途的mAb净化工艺中进行液分析.

Alfred Haglind1, Emil Håkansson2, Nils Wallménius2

  • 1Cytiva, Bjorkgatan 30, 75323 Uppsala, Sweden alfred.haglind@cytiva.com.

PDA journal of pharmaceutical science and technology
|December 26, 2024
PubMed
概括
此摘要是机器生成的。

这项研究使用一次性使用系统在单克隆抗体净化过程中追踪了可浸出物. 大多数漂水材料在处理过程中被清除,除了来自最终存储组件的漂水材料.

关键词:
生物制造 生物制造 生物制造可提取和可浸泡的材料.测试可提取物和可浸出物的测试.可漏的选选器可以漏.单次使用的生物反应器mAbAb 在线观看

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Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
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Activated Cross-linked Agarose for the Rapid Development of Affinity Chromatography Resins - Antibody Capture as a Case Study
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相关实验视频

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科学领域:

  • 生物制药制造业 生物制药制造业
  • 分析化学 分析化学

背景情况:

  • 一次性使用系统 (SUS) 越来越多地用于生物制药制造.
  • 了解可和可提取物 (L&E) 对工艺安全和产品质量至关重要.
  • 单克隆抗体 (mAb) 净化主要依赖于染色学和过步骤.

研究的目的:

  • 在封闭的,连接的mAb净化过程中选和识别可浸出物.
  • 为了比较识别的可浸出物与可提取物,从工艺设备中获取数据.
  • 为了评估在mAb净化过程的不同阶段,可浸泡材料的命运.

主要方法:

  • 使用高通量选方法,包括HS-GC-MS,GC-MS和LC-QToF/ESI (正负模式).
  • 在两个并行净化过程中从输液培养到最终储存袋收集样品.
  • 从绘制的一次性设备中,与可提取的数据相关联识别的可漏物.

主要成果:

  • 检测到广泛的可浸出物,许多化合物被提取物映射所预测.
  • 识别了常见的漏物,如乙烯基醇和劳洛拉克坦,显示了过程中的动态变化.
  • 净化过程证明了"沉"能力,在释放后不久就有效地去除了大多数可浸物.

结论:

  • 这项研究证实,一次性设备是mAb净化中的可浸物来源.
  • mAb净化过程有效地去除了大多数可浸物,验证了风险评估假设.
  • 与最终产品接触材料 (储存袋) 相关的可溶性物质仍然存在,这凸显了最后阶段材料评估的重要性.