Upstream processing for cell therapy
Compared to production volumes associated with other biologics (e.g., mAbs: 2,000L to 10,000L), cell therapy production volumes are more commonly between 1L to 10L. Even the quality parameters are different.
Instead of striving for maximum titers and protein quality, cell therapies focus on maximum cell dose for delivery and the functionality of the cells/tissues being administered.
Thus, upstream production parameters covering media, supplements, bioreactor systems, and starting cell quality are very important. In the end, when the culture process has been completed, therapeutic cells need to be harvested employing cell dissociation reagents that do not impact the quality of the cell product.