针对小规模应用的连续下游流程的自动化质量分析
Simon Tallvod1, Daniel Espinoza1, Joaquín Gomis-Fons1
1Department of Chemical Engineering, Lund University, Lund, Sweden.
Journal of chromatography. A
|May 28, 2023
概括
开发了一种自动化质量分析系统 (QAS),以简化用于集成,连续生物制造的数据采集. 该系统自动取样,准备和分析,减少手工劳动和可变性,以增强过程控制.
科学领域:
- 生物制药制造业 生物制药制造业
- 过程分析技术 过程分析技术
- 染色体学 染色体学 是一种染色学.
背景情况:
- 综合,连续的生物制造 (ICB) 需要有效的数据采集,用于监测,质量测试和控制.
- 手动样本处理引入时间延迟,劳动力成本和人为错误,阻碍了过程开发和控制.
研究的目的:
- 开发一种自动化质量分析系统 (QAS),用于在小型生物制药下游工艺中采样,制备和分析样品.
- 为了使自动化过程监控和基于数据的控制在连续生物制造.
主要方法:
- 开发了一种自动化质量分析系统 (QAS),集成AEKTA Explorer进行样品处理和Agilent 1260 Infinity II HPLC进行分析.
- 利用基于Python的轨道软件用于系统控制和通信.
- 通过连续捕获染色学过程证明了QAS用于单克隆抗体净化.
主要成果:
- 在连续捕获色谱运行过程中,QAS成功地自动化了样本采集,准备和分析.
- 在没有人类干预的情况下获得了一致的质量过程数据.
- 能够通过SEC和IEX染色学来确定聚合物含量和电荷变体组成.
结论:
- 开发的QAS有效地解决了ICB流程数据采集方面的挑战.
- 自动化减少了手工劳动和可变性,为增强的过程监控和控制铺平了道路.
- 该系统支持对生物制药生产至关重要的实时质量评估.
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