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The field of cell therapy is in its early stages but has already demonstrated immense promise. In order to realize the potential of these revolutionary treatments, however, many challenges need to be addressed, most notably safety and cost. Two universally accepted approaches to mitigating safety and cost issues are automation and scalability. The closed and automated CTS DynaCellect isolation process achieves >90% isolation efficiency of target cells with ~95% purity with no effect on cell viability, and the automated bead removal process is fast and efficient and currently results in >85% target cell recovery.
Moreover, the CTS DynaCellect is highly scalable and able to process up to 1 liter (or 10 billion target cells) per isolation reaction with a throughput time of =90 minutes, and bead removal is achieved through a continuous flow to ensure rapid processing of all volumes characteristic of autologous and allogenic workflows.Following the upstream cellular processing, stirred tank bioreactors have been identified as the most effective, scalable, and flexible, closed and automated vessels for expansion of cell therapies. They possess superior control over the culture characteristics, such as mixing, gassing and liquid exchange. These capabilities have improved yields compared to other dynamic and static bioreactors, while still maintaining the same levels of early memory cells.
Moreover, stirred tank bioreactors are associated with a relatively small footprint and can be readily assimilated, both physically and digitally, into closed and automated workflows. The CTS Dynacellect and stirred tank bioreactors, therefore, represent closed, automated, and scalable building blocks toward a cell therapy manufacturing process that can mitigate the overarching current and future challenges in safety and cost.