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推进拉曼校准:在多平行 perfusion 迷你生物反应堆中自动化数据生成,监控和控制
Rafael Machleid1,2, Maximilian Goertz3, Christian Grimm1
1Sartorius Stedim Biotech GmbH, Göttingen, Germany.
Biotechnology journal
|March 4, 2026
概括
这项研究引入了在 perfusion 生物反应器中用于拉曼光谱校准的自动化工作流程,使细胞培养物的实时监测成为可能. 这一进步支持具有成本效益的生物制药生产和高效的工艺控制.
科学领域:
- 生物制药制造业 生物制药制造业
- 过程分析技术 (PAT) 是一种分析技术.
- 频谱学是一种光谱学.
背景情况:
- 生物制药行业寻求经济高效的生产方法,以获得负担得起的治疗方法.
- 过程强化,就像 perfusion,旨在降低成本,提高生产率,减少设施规模.
- perfusion 流程由于其动态性质,需要先进的实时监控和控制.
研究的目的:
- 实现用于拉曼校准建模的自动化数据生成工作流.
- 为了证明拉曼校准模型的有效性,用于监测 perfusion 种植.
- 评估基于拉曼的出血率控制系统的可行性.
主要方法:
- 使用了一种高通量 perfusion 微型生物反应器系统 (Ambr 250 HT Perfusion).
- 开发了一种用于拉曼光谱校准的自动化数据生成工作流.
- 应用拉曼校准模型来监测多个细胞系和产品的细胞培养参数.
- 基于拉曼的出血率控制系统与传统的细胞计数方法进行了比较.
主要成果:
- 成功实现了生成拉曼校准数据的自动化工作流.
- 证明了拉曼模型在监测多种 perfusion 细胞培养中的有效性.
- 展示了基于拉曼的出血率控制策略的可行性.
结论:
- 自动化拉曼数据生成为 perfusion 过程提供了强大的校准建模.
- 拉曼光谱为生物制药制造业的实时监测和控制提供了一个强大的工具.
- 基于拉曼的控制系统为传统方法提供了可行的替代方案,提高了工艺效率.
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