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Bioprocessing of Cryopreservation for Large-Scale Banking of Human Pluripotent Stem Cells

机译：冷冻保存的人类多能干细胞大规模储存的生物加工

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Human pluripotent stem cell (hPSC)-derived cell therapy requires production of therapeutic cells in large quantity, which starts from thawing the cryopreserved cells from a working cell bank or a master cell bank. An optimal cryopreservation and thaw process determines the efficiency of hPSC expansion and plays a significant role in the subsequent lineage-specific differentiation. However, cryopreservation in hPSC bioprocessing has been a challenge due to the unique growth requirements of hPSC, the sensitivity to cryoinjury, and the unscalable cryopreservation procedures commonly used in the laboratory. Tremendous progress has been made to identify the regulatory pathways regulating hPSC responses during cryopreservation and the development of small molecule interventions that effectively improves the efficiency of cryopreservation. The adaption of these methods in current good manufacturing practices (cGMP)-compliant cryopreservation processes not only improves cell survival, but also their therapeutic potency. This review summarizes the advances in these areas and discusses the technical requirements in the development of cGMP-compliant hPSC cryopreservation process.
机译：人多能干细胞（hPSC）衍生的细胞疗法需要大量生产治疗细胞，这要从工作细胞库或主细胞库中解冻冷冻保存的细胞开始。最佳的冷冻保存和解冻过程决定了hPSC扩增的效率，并在随后的谱系特异性分化中起重要作用。然而，由于hPSC的独特生长要求，对冷冻损伤的敏感性以及实验室常用的不可扩展的冷冻保存程序，hPSC生物加工中的冷冻保存一直是一个挑战。在确定冷冻保存过程中调节hPSC反应的调节途径以及开发有效提高冷冻保存效率的小分子干预措施方面取得了巨大进展。这些方法在当前符合良好生产规范（cGMP）的冷冻保存工艺中的适应性改进不仅可以提高细胞存活率，而且还可以提高治疗效果。这篇综述总结了这些领域的进展，并讨论了开发符合cGMP的hPSC冷冻工艺的技术要求。

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