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微流体子用于基于珠子的亲和度测定.

Inês F Pinto1, Veronique Chotteau2, Aman Russom3,4

  • 1KTH Royal Institute of Technology, Division of Nanobiotechnology, Department of Protein Science, Science for Life Laboratory, Solna, Sweden.

Methods in molecular biology (Clifton, N.J.)
|May 16, 2024
PubMed
概括
此摘要是机器生成的。

一种新型的微流体子使生物制药制造中的关键蛋白质和代谢物的快速在线量化成为可能. 这个过程分析技术 (PAT) 工具为优化生物工艺和确保产品质量提供了具有成本效益的解决方案.

关键词:
生物制药产品 生物制药产品测色仪的颜色测量方法免疫测试是一种免疫测试.微流体学 微流体学单克隆抗体是一种单克隆抗体.多重复合是一种多重复合.过程分析技术 过程分析技术

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科学领域:

  • 生物技术是生物技术.
  • 分析化学 分析化学
  • 工艺工程是过程工程.

背景情况:

  • 生物制药行业面临着激烈的竞争,需要高效的流程优化以减少时间和成本.
  • 为产生单克隆抗体 (mAbs) 的哺乳动物细胞培养过程复杂且难以优化.
  • 现有的分析方法缺乏在生物反应器内实时监测的整合.

研究的目的:

  • 在生物过程监测中开发和演示用于在线蛋白质量化的微流体.
  • 解决在过程分析技术 (PAT) 中快速,综合分析工具的未满足需求.
  • 展示微流体在敏感和高效的生物过程分析方面的潜力.

主要方法:

  • 用于基于珠子的亲和度测试的微流体的制造和处理.
  • 从生物反应器样本中直接检测特定蛋白质分析物的几何复合免疫检测.
  • 量化中国大鼠卵巢 (CHO) 主体细胞蛋白质 (HCP),IgG和乳酸脱酶 (LDH).

主要成果:

  • 微流体装置在2.5小时内以最小的实践时间实现了蛋白质定量.
  • 在HCP,IgG和LDH的低ng/mL范围内显示的检测极限.
  • 显示微不足道的矩阵干扰,并且在芯片上的免疫分析之间没有交叉反应.

结论:

  • 开发的微流体检测具有生物制药制造过程分析技术 (PAT) 的巨大潜力.
  • 与当前最先进的仪器相比,这种小型化的分析方法提供了更低的成本和复杂性.
  • 能够系统地监测和量化关键分析物,以改善生物过程控制和优化.