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 CabralPublished 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.
Keyphrases
- cell therapy
- induced apoptosis
- stem cells
- stem cell transplantation
- cell cycle arrest
- end stage renal disease
- bone marrow
- newly diagnosed
- ejection fraction
- chronic kidney disease
- endoplasmic reticulum stress
- mesenchymal stem cells
- prognostic factors
- human health
- low dose
- hematopoietic stem cell
- pluripotent stem cells
- signaling pathway
- wastewater treatment
- risk assessment
- high dose
- oxidative stress