Abstract
Background & Aim The manufacturing cost and complexity has been one of the biggest obstacles for delivering cell therapy products. Here we present RoteaTM, a compact closed automation system with counterflow centrifuge technology, which enables gentle cell separation, wash, and concentration with controllable input and output volumes. The 10ml chamber on the single use kit can sustain billions of cells as a fluidized bed and can be discharged multiple times if needed. The kit can be easily connected to other closed systems for upstream and downstream applications, for example Finesse bioreactor system, making Rotea a flexible modular instrument to fit in different workflows. Methods, Results & Conclusion Using human primary T cells as a model, we have demonstrated that across different input and output settings, Rotea contributes superior processing time, recovery, and viability for cell wash, concentration, and buffer exchange as compared to manual centrifugation. More importantly, Rotea is capable of facilitating lymphocyte separation from leukopheresis products, as well as bead removal after expansion, and therefore could shorten manufacturing time of cell therapy products.
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