Computational fluid dynamic characterization of vertical-wheel bioreactors used for effective scale-up of human induced pluripotent stem cell aggregate culture

Innovations in engineering and bioprocess development have accelerated the transition of induced pluripotent stem cell (iPSC) cultivation and use from the bench-top to large-scale clinical manufacturing. Owing to their potency, proliferation capabilities, and ability to overcome the challenges associated with traditional sources of pluripotent stem cells (PSCs), iPSCs have generated significant interest in the field of regenerative medicine for more than a decade. However, traditional bench scale methods to expand iPSCs, including petri dishes and T-flasks, are insufficient to achieve clinically relevant numbers. For iPSC treatments, cell dosages will range from 109 – 1012 cells per patient depending on the therapeutic target. To achieve the required number of cells in an effective and scalable manner, bioreactors will need to be used. Induced pluripotent stem cells (iPSCs) have proven to be extremely sensitive to the bioreactor hydrodynamic environment, making the use of suspension bioreactors to produce quality-assured cells at clinical and commercial scales very challenging. The PBS vertical-wheel (VW) bioreactor combines radial and axial flow components to produce uniform hydrodynamic force distributions, making it a promising platform to overcome the scale-up challenges associated with iPSCs. Please click Additional Files below to see the full abstract