Management of handling, long-term stability and shipping of human T-lymphocytes bags for clinical studies

During the past years our group focused on the development and optimization of an industrial production process for manufacturing of lots of the non-MHC restricted human citotoxic cell line TALL-104 for cell therapy applications. To assess the behaviour of the frozen cell bags during the storage period and after long distance shipping, we performed stability experiments and shipping tests on three different TALL-104 lots produced at our facility. Cells were assayed for biological activity using a cytotoxic assay. The stability study allowed us to set the expiration date for TALL-104 lots at two years after manufacturing. The results of the shipping test showed that, after the travel in a temperature-controlled container, sterility, viability and cytotoxic activity were preserved with no detectable loss. Taken together, these results confirm the feasibility of the industrial production of TALL-104 lots for use in clinical trials, even when the trials are estabilished in structures far from the production site and the cells are reinfused after a long storage period. The possibility of storing the product for up to two years allows the extension of the application field of the product even to clinical trials where patients are not available on a regular basis.