The Scale-up of Human Mesenchymal Stem Cell Expansion and Recovery

Science and medicine has revealed the potential of cell therapies; however, for this to be realised, scalable and robust manufacturing processes must be developed for the reproducible production of clinically-relevant numbers of fully functional stem cells. It is well established that for all products made either by cell culture or fermentation, the process must be defined with equally defined critical quality attributes (CQAs) that can be monitored and controlled to ensure product safety as well as efficacy. Human mesenchymal stem cells need to be attached to a surface to grow and cannot be adapted to suspension culture. For allogeneic cell therapy processes, scale-up approaches are more likely to be employed. As well as the physical challenge of removing the cells from the microcarriers, there remains a challenge in demonstrating comparability of cell CQAs with the monolayer process, which will be essential to effectively scale up the process.