5 Considerations For Scaling-Up PSC-Derived Cell Therapies

For a cell replacement therapy to be successful, you need a significant number of differentiated cells – sometimes upward of 1 billion cells per dose. Since differentiated cells have a limited proliferation capacity in comparison to PSCs, and some cells may not integrate into host tissue, high doses of cells are needed for cell replacement therapies.  

It is worth noting that not all cell replacement therapies require large populations of differentiated cells. For instance, approaches for regeneration of the brain, eye and spinal cord require comparatively fewer differentiated cells for transplantation, -- somewhere in the tens of thousands of cells. The take home message here is that the target organ/tissue is an important factor in determining the number of cells needed. 

The team at CCRM has tackled the challenges of manufacturing scale-up for PSC-derived cell therapies numerous times. We have built expertise working with cell therapies that require up to 1 billion differentiated cells per dose and, in the process, have identified key considerations in the following areas: