利用拉曼光谱进行细胞治疗生物处理。

IF 12.1 1区 工程技术 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
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引用次数: 0

摘要

细胞疗法的生产需要对关键参数进行精确监控,以确保产品质量和一致性,并促进具有成本效益的工艺的实施。虽然传统分析方法提供的实时洞察力有限,但在生物处理过程中集成拉曼光谱等过程分析技术工具,有可能在细胞疗法生产过程中提高效率和可靠性,同时满足严格的监管要求。拉曼光谱具有非破坏性的特点,而且能与可扩展平台在线集成,因此可以连续采集数据,实现工艺参数与关键质量属性之间的实时关联。在此,我们回顾了拉曼光谱在细胞治疗生物工艺中的作用,并讨论了同时测量细胞密度、存活率、代谢物和细胞特征生物标记等不同参数和属性如何简化在线监测和促进自适应工艺控制。这反过来又提高了生产率,降低了与工艺相关的风险。我们重点介绍了将拉曼光谱技术整合到各个生产阶段的最新进展,从优化培养基进料到监控生物过程动态,涵盖了下游应用,如检测共分离的污染细胞、低温保存和药物产品的质量控制。最后,我们将讨论拉曼光谱在革新当前实践和加速先进治疗药物产品开发方面的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Harnessing Raman spectroscopy for cell therapy bioprocessing
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.
Herein, we review the role of Raman spectroscopy in cell therapy bioprocessing and discuss how simultaneous measurement of distinct parameters and attributes, such as cell density, viability, metabolites and cell identity biomarkers can streamline on-line monitoring and facilitate adaptive process control. This, in turn, enhances productivity and mitigates process-related risks. We focus on recent advances integrating Raman spectroscopy across various manufacturing stages, from optimizing culture media feeds to monitoring bioprocess dynamics, covering downstream applications such as detection of co-isolated contaminating cells, cryopreservation, and quality control of the drug product. Finally, we discuss the potential of Raman spectroscopy to revolutionize current practices and accelerate the development of advanced therapy medicinal products.
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来源期刊
Biotechnology advances
Biotechnology advances 工程技术-生物工程与应用微生物
CiteScore
25.50
自引率
2.50%
发文量
167
审稿时长
37 days
期刊介绍: Biotechnology Advances is a comprehensive review journal that covers all aspects of the multidisciplinary field of biotechnology. The journal focuses on biotechnology principles and their applications in various industries, agriculture, medicine, environmental concerns, and regulatory issues. It publishes authoritative articles that highlight current developments and future trends in the field of biotechnology. The journal invites submissions of manuscripts that are relevant and appropriate. It targets a wide audience, including scientists, engineers, students, instructors, researchers, practitioners, managers, governments, and other stakeholders in the field. Additionally, special issues are published based on selected presentations from recent relevant conferences in collaboration with the organizations hosting those conferences.
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