Advancing cellular discoveries from clinical trials to commercial therapy is a cornerstone of Mayo Clinic's strategic emphasis on biomanufacturing. The long-term vision is to provide new cures for patients with unmet needs.
"Biomanufacturing is a type of manufacturing that utilizes sources from the human body — cells, blood, enzymes, tissues, genes or genetically engineered cells for use in medicines. We call these biologics," says Julie Allickson, Ph.D., the Michael S. and Mary Sue Shannon Family Director of Mayo Clinic's Center for Regenerative Medicine. "Biologics become a living drug within the body aimed at continually healing damaged tissues and cells." Dr. Allickson is also the Otto Bremer Trust Director, Biomanufacturing and Product Development, Center for Regenerative Medicine.
Biomanufacturing next-generation drugs
Biomanufacturing could usher in a new era of biologically based medicines that show hope of going beyond available complex molecule-based drugs to treat illness.
These next-generation biotherapeutics derived from living organisms show potential to:
The Center for Regenerative Medicine is seeking to create the world's most advanced ecosystem for biomanufacturing new biotherapeutics, bringing together physicians, scientists, process development experts, high-tech facilities and industry collaborators to test and license first-of-their-kind biologics. The center will collaborate with the Mayo Clinic Comprehensive Cancer Center, the Center for Individualized Medicine, the Department of Laboratory Medicine and Pathology, Mayo Clinic Ventures, Mayo Clinic Platform, the Center for Digital Health and Mayo Clinic International to execute the biomanufacturing strategy across the institution.
Mayo Clinic has identified seven workstreams for biomanufacturing, but will initially prioritize:
Additional focus will be placed on:
Working with outside collaborators
Mayo Clinic is making significant investments in good manufacturing practices facilities in Arizona, Florida and Minnesota, which are facilities that meet strict quality control regulations required for commercial grade biotherapeutics. This strongly positions Mayo to work with a growing number of industry collaborators interested in bringing to market regenerative biotherapeutics for conditions that previously had no treatment options.
"Our emphasis will be on phase 1 and phase 2 clinical trials for technology developed at Mayo Clinic. Possibly at that time, we might work with industry collaborators that either want to license the technology or launch a startup company," says Dr. Allickson.
Health care costs for chronic and complex diseases run in the billions of dollars every year. Mayo's goal in developing expertise in new biologic-based medicines is to bring the cost of care down while providing new hope for patients.