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Challenges and opportunities in the manufacture and expansion of cells for therapy

机译：治疗细胞制造和扩展的挑战和机遇

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Introduction: Laboratory-based ex vivo cell culture methods are largely manual in their manufacturing processes. This makes it extremely difficult to meet regulatory requirements for process validation, quality control and reproducibility. Cell culture concepts with a translational focus need to embrace a more automated approach where cell yields are able to meet the quantitative production demands, the correct cell lineage and phenotype is readily confirmed and reagent usage has been optimized.Areas covered: This article discusses the obstacles inherent in classical laboratory-based methods, their concomitant impact on cost-of-goods and that a technology step change is required to facilitate translation from bed-to-bedside.Expert opinion: While traditional bioreactors have demonstrated limited success where adherent cells are used in combination with microcarriers, further process optimization will be required to find solutions for commercial-scale therapies. New cell culture technologies based on 3D-printed cell culture lattices with favourable surface to volume ratios have the potential to change the paradigm in industry. An integrated Quality-by-Design /System engineering approach will be essential to facilitate the scaled-up translation from proof-of-principle to clinical validation.
机译：简介：基于实验室的exvivo细胞培养方法在其制造过程中大部分是手动的。这使得符合过程验证，质量控制和可重复性的监管要求非常困难。具有翻译焦点的细胞培养概念需要采用更自动化的方法，其中细胞产量能够满足定量的生产要求，易于证实的正确细胞谱系和表型并进行了优化的使用。本文讨论了障碍：本文讨论了障碍物基于实验室的方法中固有的，它们对商品成本的影响以及技术步骤改变是为了促进床上的翻译，以便意见：虽然传统的生物反应器已经证明使用粘附细胞的有限成功结合微载波，需要进一步的过程优化来寻找商业规模疗法的解决方案。新的细胞培养技术基于3D印刷的细胞培养格子，具有良好的体积比具有良好的体积比具有潜力改变工业中的范式。综合质量逐个设计/系统工程方法对于促进原则上的缩放翻译至关重要，以促进临床验证。

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