Cell Culture Process Scale-Up Challenges for Commercial-Scale Manufacturing of Allogeneic Pluripotent Stem Cell Products
Brian Lee, Sunghoon Jung, Yas Hashimura, Maximilian Lee, Breanna S. Borys, Tiffany Dang, Michael S. Kallos, Carlos A. V. Rodrigues, Teresa P. Silva, Joaquim M. S. Cabral
Abstract
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.
Topics & Concepts
Induced pluripotent stem cellScale (ratio)Manufacturing processProcess (computing)Stem cellSCALE-UPBioreactorBiotechnologyBiochemical engineeringComputer scienceMaterials scienceEngineeringBiologyEmbryonic stem cellCell biologyGeneticsQuantum mechanicsOperating systemComposite materialClassical mechanicsGenePhysicsBotanyPluripotent Stem Cells Research3D Printing in Biomedical ResearchCRISPR and Genetic Engineering