Mesenchymal stromal cells (MSCs) are important to the emerging field of regenerative medicine because of their unique qualities and their effect on surrounding tissue, stimulating tissue repair and modifying the body’s immune response. It is possible to use MSCs for autologous (patient specific) and for allogenic (patient to patient) cell therapies.
Numerous studies report the use of MSCs for different treatments, from tissue repair to inflammatory diseases. However, in order to facilitate the transition from bench to broad clinical application, new ways must be found to increase cell production capabilities.
The manufacture of cell based products brings novel challenges due to the inherent complexity of the final therapeutic agent. Up to now, cells for therapeutic use have mainly been produced manually, giving rise to many issues, such as risk of contamination and increased variability between batches. The use of closed automated systems will reduce the likelihood of human error and improve the quality and throughput of cell production. Increased automation will also address regulatory concerns, by delivering reliable replication and allowing comprehensive and centralized recording and storage of production data.
The AUTOSTEM project is developing a closed robotic platform to achieve fully automated manufacture of MSCs that requires no direct human interaction with the product. In AUTOSTEM, bone marrow is harvested from patients using a novel harvesting device. This bone marrow is then delivered into the pipeline, where MSCs are isolated, cultured and expanded. The environment in the pipeline bioreactors can be monitored (using customised sensor technology) to ensure optimum conditions are maintained. Progress through the pipeline is fully automated. The output of the pipeline will ultimately be clinical quantities of high quality MSCs. Thus, the AUTOSTEM project aims to enable lower-cost, higher quality and more consistent MSCs to be produced, ultimately helping patients to benefit from new cell therapies.
