Scale-Up Of Hepatic Progenitor Stem Cells From Multiple Tray Stack To 2-D Bioreactors
Cell therapy is offering a promising future in medical advances. While multilayer trays for cell amplification are suitable for R&D and preclinical purposes, they cannot support large-scale industrial production. A successful transition from laboratory scale to an efficient and robust process based on good manufacturing practices (GMP) is key. Implementing innovative technologies is essential and represents a major challenge for cell-based product manufacturing.
Integrity® Xpansion™ multiplate bioreactors have been specifically designed to enable an easy transfer from existing multiple-tray-stack processes by offering the same cell growth environment on 2-D hydrophylized Polystyrene (PS) plates in a fully closed system. To make the bioreactors compact, the headspace between each plate has been reduced to a minimum (1.3mm). Gas transfer is made through a semi-permeable silicone tubing mounted in the central column. A magnetic stirrer at the bottom of the bioreactor ensures a homogenized distribution of gas. Preserving the cell culture environment is critical, as small variations in physicochemical parameters, such as surface characteristics, can heavily impact stem cell growth and behavior. Additionally, critical cell culture parameters such as pH and DO are controlled and the cell density is automatically monitored via a specific holographic microscope developed by the Belgian technology company Ovizio.