PRODUCTION ASSISTANCE FOR CELLULAR THERAPIES (PACT)- CELL PROCESSING FACILITIES CELL MANUFACTURING AND PROCESS DEVELOPMENT SERVICES FOR RSA PCT0005-02: CRYOPRESERVATION TECHNICAL STUDY

大多数细胞疗法都需要优化冷冻保存技术。这一小组项目将允许PACT的四个地点评估无DMSO的冷冻保存介质，该介质有可能改善“难以冷冻保存”细胞的活性和功能，它还将允许直接输注冷冻保存的细胞，而无需事先清洗，并消除DMSO对细胞的输注反应和毒性。本研究比较了无DMSO培养液和目前的室内冷冻保存方法(S法)。 冷冻保存的优化对临床研究结果有很大影响。至少，对最佳可行和功能性产品的保证将消除在失败的研究中起作用的产品变量

Optimization of the cryopreservation techniques is needed for most cell therapies. This group project will allow four of the PACT sites to assess the DMSO-free cryopreservation medium which has the potential to improve viability and function of “hard-to-cryopreserve” cells, it would also enable infusion of cryopreserved cells directly without prior washing, and eliminate infusion reactions and toxicity to cells due to DMSO. This study involves the comparison of the DMSO free media to current in-house method(s) for cryopreservation. Optimization of cryopreservation play an impact on clinical study outcomes. At a minimum, assurance of an optimally viable and functional product would remove the product variable as playing a role in a failed study