Microfluidic Devices as Process Development Tools for Cellular Therapy Manufacturing.
Microfluidic Devices as Process Development Tools for Cellular Therapy Manufacturing.
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微流体装置作为细胞治疗制造的工艺开发工具。
DOI：
10.1007/10_2021_169
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Aranda Hernandez J
中科院分区：
文献类型：
--
作者：
Aranda Hernandez J
细胞疗法正在为生物制造行业带来范式转变。特别是对于自体疗法，小规模加工方法比业界传统采用的大规模方法更适合。然而，目前用于制造个性化细胞疗法的小规模方法是劳动密集型的，并且涉及许多“开放事件”。为了克服这些挑战，遵循盒装 GMP 概念的新细胞制造平台最近已上市（GMP：良好生产规范）。这些是封闭式自动化系统，带有用于流体处理的内置泵和用于过程监控的传感器。在较小的规模上，微流体装置表现出许多与当前 GMP 盒装系统相同的功能。它们是封闭系统，可以处理和操纵流体，并且集成传感器用于实时检测过程变量。它们由聚合物制成，可以制成一次性的，即一次性使用。此外，微流体提供了对细胞微环境的精确时空控制，保证了结果的可重复性和控制。在本章中，我们考虑了细胞制造中的挑战，重点介绍了每个主要工艺步骤的微流体装置的最新进展，并总结了我们对当前技术水平的发现。由于微流体细胞培养装置已被报道用于贴壁和悬浮细胞培养，因此我们报告了用于干细胞疗法和基于细胞的免疫疗法的关键工艺步骤或单元操作的装置。图形摘要
Cellular therapies are creating a paradigm shift in the biomanufacturing industry. Particularly for autologous therapies, small-scale processing methods are better suited than the large-scale approaches that are traditionally employed in the industry. Current small-scale methods for manufacturing personalized cell therapies, however, are labour-intensive and involve a number of ‘open events’. To overcome these challenges, new cell manufacturing platforms following a GMP-in-a-box concept have recently come on the market (GMP: Good Manufacturing Practice). These are closed automated systems with built-in pumps for fluid handling and sensors for in-process monitoring. At a much smaller scale, microfluidic devices exhibit many of the same features as current GMP-in-a-box systems. They are closed systems, fluids can be processed and manipulated, and sensors integrated for real-time detection of process variables. Fabricated from polymers, they can be made disposable, i.e. single-use. Furthermore, microfluidics offers exquisite spatiotemporal control over the cellular microenvironment, promising both reproducibility and control of outcomes. In this chapter, we consider the challenges in cell manufacturing, highlight recent advances of microfluidic devices for each of the main process steps, and summarize our findings on the current state of the art. As microfluidic cell culture devices have been reported for both adherent and suspension cell cultures, we report on devices for the key process steps, or unit operations, of both stem cell therapies and cell-based immunotherapies.Graphical Abstract
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自动化：未来的细胞治疗实验室会是什么样子？
DOI：
--
发表时间：
2018
期刊：
Cell and Gene Therapy Insights
影响因子：
--
作者：
W. Leong;B. Nankervis;J. Beltzer
通讯作者：
J. Beltzer
微流体细胞培养装置中胚胎干细胞的特定氧气吸收速率的实时监测。
影响因子：
4.7
作者：
Super, Alexandre;Jaccard, Nicolas;Marques, Marco Paulo Cardoso;Macown, Rhys Jarred;Griffin, Lewis D.;Veraitch, Farlan Singh;Szita, Nicolas
通讯作者：
Szita, Nicolas
DOI：
10.1016/j.procbio.2016.09.006
发表时间：
2017-08
期刊：
Process biochemistry (Barking, London, England)
影响因子：
--
作者：
Raimes W;Rubi M;Super A;Marques MPC;Veraitch F;Szita N
通讯作者：
Szita N
影响因子：
2.7
作者：
Roberts, Iwan;Baila, Stefano;Mason, Chris
通讯作者：
Mason, Chris
影响因子：
6.1
作者：
Kang W;Giraldo-Vela JP;Nathamgari SS;McGuire T;McNaughton RL;Kessler JA;Espinosa HD
通讯作者：
Espinosa HD