Abstract
In order to ensure a standardized and consistent Drug Product freezing and to minimize batch-to-batch differences in cell recovery and viability postthaw, TxCell scientists tested the CoolCell container, a passive freezing device, as an alternative to the classical controlled rate freezer. Results showed that by using a CoolCell freezing device, Ag-Tregs can be successfully cryopreserved and recovered in a standardized way acceptable to the processing and manufacturing of cell therapies. TxCell now intends to use the CoolCell device in its phase IIb clinical study with its lead AgTreg cell product candidate, Ovasave . Use of the CoolCell passive freezing device for cell therapy manufacturing of Ag-Treg represents a new standardized method of cell therapy product cryopreservation. The ability to develop and store functional Treg in a cost-effective and reproducible manner is an important milestone in the ultimate use of these cells in the clinic.
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