Scale-up of human mesenchymal stem cell culture: current technologies and future challenges

Regenerative medicine technologies have the potential to revolutionise human healthcare. However, whilst science has revealed the potential, and early products have shown the power of such therapies, there is now a need for the long-term supply of human stem cells in sufficient numbers to create reproducible and cost effective therapeutic products. The industrial platforms to be developed for human cell culture are in some ways analogous to those already developed for biopharmaceutical production using mammalian cells at large scales. However, there are a number of unique challenges that need to be addressed, largely because the quality of the cell is paramount, rather than the proteins that they express.

► Cell based therapies can cure rather than treat medical conditions.
► There is a need to obtain clinically relevant numbers of fully functional hMSCs.
► This need cannot be met by traditional manual culture methods alone.
► Microcarrier technology can be used to generate clinically relevant numbers of hMSCs.
► Concomitant novel downstream processing unit operations need to be developed.