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预测原材料对商业生物治疗制造中的细胞培养参数的影响
Phyllis C Pugh1, Bijay R Khanal1, Jenna L Lemons1
1Manufacturing Sciences and Technology, Operations, Biologics Supply, AstraZeneca, Frederick, Maryland, USA.
Biochemistry and biophysics reports
|August 18, 2025
概括
哺乳动物细胞培养中的原材料变异性会影响生物产品的产量. 这项研究使用富里埃变换红外光谱 (FTIR) 和部分最小方程 (PLS) 回归来建模和预测原材料质量如何影响抗体生产.
科学领域:
- 生物技术是生物技术.
- 化学工程是化学工程的重要组成部分.
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 哺乳动物细胞培养对于生产生物治疗药物至关重要.
- 复杂的介质组件引入影响产品产量的变化.
- 确保原材料质量对于持续的生物工艺性能至关重要.
研究的目的:
- 研究原材料质量对哺乳动物细胞培养生产率的影响.
- 开发基于数据的模型来估计最终产品的产量.
- 预测原材料变异对生物治疗分子产量的影响.
主要方法:
- 福利埃变换红外光谱法 (FTIR) 用于分析原材料组件.
- 应用了化学测量技术,包括部分最小平方 (PLS) 回归.
- 开发了基于数据的模型,以将原材料特性与工艺结果相关联.
主要成果:
- 化学测量模型成功估计了原材料可变性的影响.
- 开发的模型可以预测原材料质量对抗体生产产量的影响.
- 与PLS回归相结合的FTIR光谱学为原材料表征提供了强大的方法.
结论:
- 原材料质量显著影响生物制药生产产量.
- 使用光谱数据的数据驱动建模可以优化和控制细胞培养过程.
- 实施FTIR等PAT工具可以提高流程理解,并确保产品的一致性.
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