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Cell Culture Process Scale-Up Challenges for Commercial-Scale Manufacturing of Allogeneic Pluripotent Stem Cell Products.

Brian LeeSunghoon JungYas HashimuraMaximilian LeeBreanna S BorysTiffany DangMichael Scott KallosCarlos A V RodriguesTeresa P SilvaJoaquim M S Cabral
Published in: Bioengineering (Basel, Switzerland) (2022)
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.
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