S35: Challenges for stem cell bioprocessing- scale-up or scale-out?

The last 15 years has seen the growth of a new and global healthcare industry based on human proteins produced in genetically engineered mammalian cells with an estimated current market value of ~£30 billion a year. There is now an opportunity to replicate this growth in the new industry of regenerative medicine. 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 scale-up techniques to be developed for human cells are in some way 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. These challenges will be discussed here but from an engineering rather than biological point of view.