Automated bioreactor-based manufacturing of tissue grafts
Despite advances in in the field of regenerative medicine, there are significant hurdles that prevent the widespread clinical adoption of regenerative treatments. Bioreactor systems could play a central role in overcoming current limitations, facilitating broad utilization and commercialization of cell-based grafts as therapeutic solutions. Bioreactors provide a controlled and regulated culture environment that minimises product variability, and their continuous monitoring capacity increases compliance to regulatory guidelines. Automating the manufacturing process would also enable the improvement of safety and cost-effectiveness. Scientists of the EU-funded BIO-COMET (Bioreactor-based, clinically oriented manufacturing of engineered tissues) project developed a sensor-based bioreactor system for the production of functional, autologous engineered grafts for cartilage repair. Innovative features of the BIO-COMET cartilage graft manufacturing strategy included an automated and controlled production system, bioreactor developed for regulatory compliance, simplified, streamlined, and scalable tissue engineering process, and online monitoring of culture/quality parameters, as well as data management for traceability. The developed bioreactor-based manufacturing system was transferred to a GMP test facility and used for pre-clinical large animal studies. The results obtained from the pre-clinical studies indicated not only the feasibility of use of bioreactor generated cartilage grafts, but also show superiority in terms of the quality of cartilage repair in a large animal model. This project will be instrumental in extending use of bioreactor-based platforms beyond cartilage tissue engineering, with the ultimate goal to facilitate broad utilization and commercialization of cell-based grafts as therapeutic solutions.
Keywords
Bioreactor, cell therapy, tissue therapy, regenerative medicine, cartilage, chondrocyte
