The Marcus Foundation awarded a $15.7 million grant to the Georgia Institute of Technology to help launch a research center that will develop processes and techniques for the large-scale manufacture of living cells for use in cell-based therapies. Potential targets include disorders such as cancer, lung fibrosis, autism, neuro-degenerative and autoimmune diseases, and spinal-cord injury.
The work of the new Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) is expected to provide standardized production and quality testing of these living cells, similar to that which already exists for drug-based pharmaceuticals. The center will include a validation facility for good manufacturing practices in cell production.
“The aspirin you buy today from one pharmacy is essentially the same as the aspirin you buy from another pharmacy, but cell-based therapies may have different efficacy depending on the source and manufacturing processes,” said Krishnendu Roy, Ph.D., Robert A. Milton Chair and professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. “There are established ways to quickly assess the efficacy and safety of small-molecule drugs that are acceptable around the world. We want to develop and establish similar processes for therapeutic cell manufacturing.”
Ultimately, the growing need for these cell therapeutics could require large-scale production facilities similar to those used in today’s pharmaceutical production. But living stem cells and immune system cells are readily affected by the varying conditions under which they are grown, stored, and packaged, meaning the same type of cell produced at different facilities could behave very differently. Unless those cells can be produced with consistency, in large scale and at low cost with high quality, use of the new cell therapies could be limited and their promise would not extend to large numbers of patients.
“The critical goal is to either minimize differences caused by varying manufacturing conditions, or to have a very defined characterization process so we know exactly how much the cells have changed and what specific characteristics are predictive of their efficacy in patients,” explained Dr. Roy, who will lead the new center. “That consistency will allow us to produce affordable products that can make this new technology available to the large community of people who need it.”