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使用拉曼光谱和PLS回归模型在10升生物反应器中监测营养素,代谢物,IgG量和细胞密度

Morandise Rubini¹, Julien Boyer², Jordane Poulain²

¹Centre de Biophysique Moléculaire (UPR CNRS 4301), Département Nanomédicaments et Nanosondes, UFR de Pharmacie Philippe Maupas, Université de Tours, 31 avenue Monge, 37 000 Tours, France.

|April 26, 2025

概括

拉曼光谱技术可以实时监测中国仓鼠卵巢 (CHO) 细胞培养代谢和免疫球蛋白G (IgG) 标位. 这种非侵入性技术支持自动化生物工艺控制,用于一致的生物制药生产.

科学领域:

生物技术是生物技术.
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:

中国仓鼠卵巢 (CHO) 细胞代谢是复杂的,受营养素和代谢物的影响.
实时监测对于优化细胞培养条件和产品质量至关重要.
拉曼光谱为生物过程提供非侵入性,现场监测能力.

研究的目的:

评估拉曼光谱技术,以实时监测CHO细胞培养中的关键代谢参数.
评估拉曼光谱在预测免疫球蛋白G (IgG) 标位方面的准确性.
为了证明拉曼光谱在提高生物过程控制和一致性方面的潜力.

主要方法:

拉曼光谱法应用于5个10L规模的CHO细胞培养物.
部分最小平方 (PLS) 回归模型是使用四个批次的数据开发的,其中一个是诱导细胞死亡.
模型与盲目测试套件进行了验证,以确保强度.

主要成果:

对于监测的参数,PLS模型显示出高预测精度 (R2>0.9).
对葡萄糖和IgG标位 (RMSEP = 0.51g/L和0.12g/L,分别) 实现了可靠的预测.
由于缺乏直接的拉曼信号,对活力和总细胞密度的预测不太准确.

结论:

拉曼光谱是实时,现场生物过程监测的可行工具,消除了手动采样的需要.
化学测量分析,特别是PLS,提高了自动控制系统的模型稳定性.
拉曼光谱法促进了关键营养素的持续反调节,确保了生物制药制造中一致的关键质量属性 (CQAs).

关键词:

在CHO细胞培养中,预测IgG标位的IgG标位预测拉曼光谱法拉曼光谱法生物过程监测监控化学测量分析化学分析部分最小平方 (PLS) 回归回归过程分析技术 (PAT) 是一种分析技术.

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