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

对于大多数细胞疗法，需要优化冷冻保存技术。该小组项目将允许四个PACT研究中心评估无DMSO冷冻保存培养基，该培养基有可能改善“难以冷冻保存”细胞的活力和功能，还可以直接输注冷冻保存细胞而无需事先清洗，并消除输注反应和DMSO对细胞的毒性。本研究涉及无DMSO培养基与当前内部冷冻保存方法的比较。 冷冻保存的优化对临床研究结果有影响。至少，保证最佳可行性和功能性产品将删除在失败研究中发挥作用的产品变量

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