Challenges and Solutions for Commercial Scale Manufacturing of Allogeneic Pluripotent Stem Cell Products.
Brian LeeBreanna S BorysMichael S KallosCarlos A V RodriguesTeresa P SilvaJoaquim M S CabralPublished in: Bioengineering (Basel, Switzerland) (2020)
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.
Keyphrases
- cell therapy
- induced apoptosis
- stem cells
- stem cell transplantation
- cell cycle arrest
- end stage renal disease
- bone marrow
- wastewater treatment
- ejection fraction
- chronic kidney disease
- newly diagnosed
- prognostic factors
- endoplasmic reticulum stress
- cell death
- pluripotent stem cells
- patient reported outcomes
- oxidative stress
- low dose
- peritoneal dialysis
- risk assessment
- climate change
- human health