Allogeneic cell therapy products, such as therapeutic cells derived from pluripotent stem cells (PSCs), have amazing potential to treat a wide variety of diseases and vast numbers of patients globally. However, there are various challenges related to manufacturing PSCs in single-use bioreactors, particularly at larger volumetric scales. This manuscript addresses these challenges and presents potential solutions to alleviate the anticipated bottlenecks for commercial-scale manufacturing of high-quality therapeutic cells derived from PSCs.
Keywords: allogeneic cell therapy; cell aggregate; computational fluid dynamics; differentiation; expansion; homogeneous hydrodynamic environment; human embryonic stem cell; induced pluripotent stem cell; medium exchange; oxygenation; scalable manufacturing; scale up; shear stress; single-use bioreactor; turbulent energy dissipation rate; vertical-wheel.