基于Raman的PAT用于VLP降水:系统的数据多样化和预处理管道识别.
Annabelle Dietrich1, Robin Schiemer1, Jasper Kurmann1
1Institute of Process Engineering in Life Sciences, Section IV: Biomolecular Separation Engineering, Karlsruhe Institute of Technology (KIT), Karlsruhe, Germany.
拉曼光谱能够实时监测病毒样粒子 (VLP) 沉,这是生物制药制造的关键步骤. 这个过程分析技术 (PAT) 工具量化了VLP和沉物,改善了过程理解和控制.
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:
- 病毒样颗粒 (VLP) 是疫苗和药物输送的关键生物制药.
- 捕获VLP通常涉及从澄清 lysates的选择性沉.
- 目前对VLP降水的监测方法耗时,缺乏直接产品量化.
研究的目的:
- 开发和验证基于拉曼光谱的过程分析技术 (PAT) 工具,用于监测VLP沉.
- 为了实时同时量化沉的VLP和沉物.
- 克服传统,劳动密集型分析方法的局限性.
主要方法:
- 应用拉曼光谱学与化学测量方法 (部分最小平方模型) 结合.
- 开发PAT工具,使用B型肝炎核心抗原VLP的批量和食批量沉实验.
- 系统地识别数据预处理管道,以处理复杂的混合和干扰.
主要成果:
- 拉曼光谱学成功预测了R2值为0.98 (批量) 和0.97 (养批量) 的沉物度.
- 该工具捕获了降水趋势,R2值为0.74 (批量) 和0.64 (养批量).
- 通过优化数据预处理,可以有效地消除 lysate 组成变化和干扰.
结论:
- 拉曼光谱作为监测VLP沉过程的基础PAT传感器.
- 这种方法提供了对VLP沉动态的实时洞察,改善了过程控制.
- 该方法有可能应用于其他依赖相位行为的过程和分子监测.
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