Vertical-WheelTM bioreactors can be the enabling single-use technology for large-scale manufacturing of allogeneic cell therapy products such as mesenchymal stem cells (MSCs) and pluripotent stem cells (PSCs). The unique benefits of a Vertical-Wheel bioreactor include the capability to uniformly suspend anchorage-dependent cells grown on microcarriers (such as MSCs) or aggregates of cells (such as PSCs) in an environment of low hydrodynamic shear stress. Homogeneous distribution of dissipation energy inside the vessel consistently generates uniform PSC aggregates, with optimal aggregate size controlled by adjusting the agitation speed. Having the suspension and size of PSC aggregates be uniform is critical for maximizing cell growth and improving the efficiency of subsequent directed differentiation in a bioreactor. Furthermore, the low shear environment and homogeneous dissipation energy levels are consistent across various sizes of Vertical-Wheel bioreactors ranging from 0.5L to 80L, resulting in true, unparalleled scalability for manufacturing of cell therapy products. High-yield cell culture processes for MSCs and human primary cells grown on microcarriers have been successfully scaled up from laboratory benchtop scale to manufacturing scale in Vertical-Wheel bioreactors. In the case of PSCs, optimal cell aggregate size and pluripotency were also maintained even after multiple passages of cell expansion in laboratory-scale bioreactors, which will allow for cell expansion and differentiation into target cells at larger scales.
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