Automation: what will the cell therapy laboratory of the future look like?
Automation: what will the cell therapy laboratory of the future look like?
复制标题
自动化：未来的细胞治疗实验室会是什么样子？
DOI：
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发表时间：
2018
期刊：
影响因子：
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通讯作者：
J. Beltzer
中科院分区：
文献类型：
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作者：
W. Leong;B. Nankervis;J. Beltzer
随着最近CAR-T细胞疗法的成功，人们对生物加工和满足需求所需的生产设施重新产生了兴趣。增加任何过程的规模都有潜在的风险和回报。虽然自动化的驱动力是明确的，但在战略上存在很多争论。是否以及何时自动化某一特定步骤的决定可能会对治疗的商品成本（COGs）及其成功产生长期影响。自动化流程中最复杂和最容易出错的步骤被认为是手动流程的最佳替代方案。然而，自动化可能是不可能的，甚至不推荐对流程中的所有步骤进行自动化。在这里，我们将探讨自动化的障碍和优势。此外，对自体CAR-T细胞过程自动化的详细讨论将着眼于从收集到输注的每个步骤，并讨论当前的自动化产品，并推测未来可能的工艺变化。通过过程分析的应用，我们可以更深入地了解过程的一致性，并定制自动化以适应过程。新的效价分析方法将改进生产工艺，确保提供安全有效的产品。这些进步将塑造我们未来的细胞治疗实验室。
With the recent successes of CAR-T cell therapies there has been a renewed interest in bioprocessing and the manufacturing facilities required to meet the demands. Increasing the scale of any process has potential risks as well as rewards. While the drive to automation is clear, there is a lot of debate on the strategy. The decision on whether and when to automate a particular step can have long-term consequences on the therapies’ cost-of-goods (COGs) and their successes. Automating the most complex and error-prone steps of a process is thought to be the best alternative to manual processes. However, automation may not be possible or even recommended for all steps in a process. Here, we examine both the barriers and the advantages of automation. Additionally, a detailed discussion of automating the autologous CAR-T cell process will look at each step from collection to infusion, and discuss the current automation offerings and speculate on potential future process changes. Through application of process analytics, we can gain a deeper understanding of the processes’ consistency and tailor automation to fit the process. New potency assays will improve manufacturing processes and ensure the delivery of a safe and effective product. These advancements will then shape the cell therapy laboratory of our future.
影响因子：
4.5
作者：
Stroncek DF;Ren J;Lee DW;Tran M;Frodigh SE;Sabatino M;Khuu H;Merchant MS;Mackall CL
通讯作者：
Mackall CL
影响因子：
20.3
作者：
Imai, C;Iwamoto, S;Campana, D
通讯作者：
Campana, D