Performance Period: 9/1/2018 to 10/31/2019
Adoptive T cell immunotherapy has become an important approach to cancer therapy with two therapies, tisagenlecleucel and axicabtagene ciloleucel, achieving FDA approval in 2017. Manufacturing of T cell-based therapies both consistently and cost-effectively remain major challenges in the field. Current approaches such as microbead-based selection and activation require multi-stage, open processes with significant human interaction, which contributes to the high-cost for cGMP manufacturing of these therapies. This application will focus on development of an integrated process/platform development based on a novel perfusion-based, microbead-free 3D bioreactor to achieve the selection, activation, and gene transduction of T cells in a single continuous processing system. This beads-free, closed-loop system is expected to simplify the manufacturing process and form the foundation for achieving full automation. In addition, this system is designed to facilitate scaling for different applications that can be applied across a broad array of T-cell based applications to reduce the development cost, shorten the transition time from discovery to manufacturing, and have high impact to the immunotherapy of cancer, and bring benefits to the patients. The technology will start at MRL 4 and end at MRL 5 for this application.
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Southwest Research Institute