Cell therapy manufacturing requires precise monitoring of critical parameters to ensure product quality, consistency and to facilitate the implementation of cost-effective processes. While conventional analytical methods offer limited real-time insights, integration of process analytical technology tools such as Raman spectroscopy in bioprocessing has the potential to drive efficiency and reliability during the manufacture of cell-based therapies while meeting stringent regulatory requirements. The non-destructive nature of Raman spectroscopy, combined with its ability to be integrated on-line with scalable platforms, allows for continuous data acquisition, enabling real-time correlations between process parameters and critical quality attributes.

中文翻译：

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利用拉曼光谱进行细胞治疗生物工艺


细胞治疗药物生产需要精确监测关键参数，以确保产品质量、一致性，并促进经济高效工艺的实施。虽然传统的分析方法提供的实时见解有限，但将过程分析技术工具（如拉曼光谱）集成到生物工艺中，有可能提高基于细胞的疗法生产过程中的效率和可靠性，同时满足严格的监管要求。拉曼光谱的非破坏性特性，结合其与可扩展平台在线集成的能力，允许连续数据采集，从而实现工艺参数和关键质量属性之间的实时关联。