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 the manufacturing of PSCs in large enough quantities to meet commercial needs. This manuscript addresses the challenges for the process development of PSCs production in a bioreactor, and also presents a scalable bioreactor technology that can be a possible solution to remove the bottleneck for the large-scale manufacturing of high-quality therapeutic cells derived from PSCs.
Keywords: U-shaped vessel; Vertical-Wheel; allogeneic cell therapy; cell aggregate; computational fluid dynamics; differentiation; expansion; homogeneous hydrodynamic environment; human embryonic stem cell; induced pluripotent stem cell; scalable manufacturing; scale up; shear stress; single-use bioreactor; turbulent energy dissipation rates.