The role of preservation in the variability of regenerative medicine products.

The role of preservation in the variability of regenerative medicine products.
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DOI:
10.1007/s40883-019-00110-9
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发表时间:
2019
影响因子:
2.6
通讯作者:
Hubel A
Hubel A
中科院分区:
其他
文献类型:
--
作者:
Yu G;Hubel A

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再生医学(RM)有可能恢复或建立因年龄,疾病或损伤而失去的细胞,组织和器官的正常功能。RM产品的原材料采集地点、生产地点和临床使用地点通常不同,同时细胞在不同地点之间运输期间必须保持活力和功能。将产品冷冻至低温沿着冷链运输已成为保存RM产品的有效方法。该供应链中RM产品的质量沿着代表了所有工艺步骤和工艺中使用的所有试剂的累积效应。RM产品保存过程中的各种可变性来源可导致细胞损失和RM产品质量的更大可变性。本文的目的是审查在保存过程中的可变性的来源,以及可变性可以控制或避免的方法。涉及使用同种异体或自体细胞和组织的RM产品通常在运输前进行冷冻保存。保存过程的每个步骤都是变异性的潜在来源,可能导致RM产品质量的变异性。这篇综述概述了保存过程中变异性的来源,以及可用于控制或减少变异性的简单做法。未来的工作将侧重于将临床结果与已执行的处理相结合,以确定RM产品质量不一致的根本原因,以及探索简化和自动化保存处理步骤的可能性,以减少可能存在的总体变异性。
Regenerative medicine (RM) has the potential to restore or establish normal function of cells, tissues and organs that have been lost due to age, disease or injury. It is common for the site of raw material collection, site of manufacture and site of clinical use to be different for RM products, and at the same time cells must remain viable and functional during transportation among different sites. Freezing products down to cryogenic temperatures along with cold chain transportation has become an effective method of preserving RM products. The quality of RM products along this supply chain represents the cumulative effects of all of the processing steps and all of the reagents used in the process. A variety of sources of variability in the preservation of RM products can result in both cell losses and greater variability in the quality of RM products. The purpose of this article is to review the sources of variability in the preservation process as well as the methods by which variability can be controlled or avoided. RM products involving the use of allogeneic or autologous cells and tissues are typically cryopreserved before shipping. Each step of the preservation process is a potential source of variability and can probably result in variability in the quality of RM products. This review provides an overview of the sources of variability in the processing of preservation and simple practices that can be used to control or reduce the variability. Future work will focus on incorporation of clinical outcomes with processing that has been performed to identify the root cause of quality inconsistency of RM products, as well as exploring the possibilities of simplifying and automating processing steps of preservation in order to reduce the overall variability that might be present.
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