The grand opening of the new Discovery and Innovation Building at Mayo Clinic’s Florida campus signals a new era of integrating regenerative medicine into daily practice. Regenerative medicine seeks to tap the body’s ability to replace, restore or regrow damaged or diseased cells, tissues and organs. A hub of research and technology, the new building could advance new regenerative treatment options for lung disorders, transplants, arthritis, and many other conditions.
“It will bring us closer to our goal of making Mayo Clinic in Florida the regenerative medicine destination center of the Southeast,” says Abba Zubair, M.D., Ph.D., who specializes in transfusion medicine and regenerative medicine on Mayo Clinic's Florida campus. “The Discovery and Innovation Building provides space that will significantly expand our capacity to support clinical trials in Florida.”
On the first floor of the Discovery and Innovation Building, Mayo Clinic and United Therapeutics Corporation are collaborating to combine expertise on United Therapeutics’ new lung technology known as lung perfusion technology. Lung perfusion is a pioneering technology that may increase the number of lungs available for transplant. It is a process by which marginal donor lungs are restored through flushing and ventilation while monitored in isolation. This preserves lungs for transplantation that otherwise would have been discarded. The lungs will be made available to patients at Mayo Clinic and other transplant centers throughout the United States.
In addition to lung restoration, researchers will use stem cells from healthy volunteer donors in the setting of FDA approved clinical trials to treat lung rejection (transplant related bronchiolitis obliterans), stroke, chronic obstructive pulmonary disease, interstitial lung disease, vascular fistulas and many more trials in the pipeline.
“We’re at a pivotal point in the field of regenerative medicine,” says Dr. Zubair. “We’re now able to expand our knowledge across specialties and are starting to look at scaling up production in order to effectively reach more patients.”
The building will also feature a Current Good Manufacturing Practices (cGMP) laboratory, which is important to assure proper design, monitoring, and control of manufacturing processes. A cGMP facility follows current good manufacturing practice regulations established and enforced by the Food and Drug Administration (FDA), ensuring the quality of drugs, medical devices and blood.
Here, in coordination with enterprise-wide biomanufacturing activities, a Mayo Clinic cGMP laboratory will focus on manufacturing allogenic (donor-derived), engineered, and automated regenerative medicine products. The testing and optimizing of automation in biomanufacturing will lead to scale up of regenerative products in order to produce better, safe and cost-effect products, such as engineered allogenic mesenchymal (adult) stem cells.
Studies have already been done to advance the cell therapy space through identification of suitable donors, ideal tissue sources, the optimized bioreactor conditions and novel methodology for cell administration.
The new cGMP facility is expected to be fully operational by the end of 2020; however, clinical trials are already underway in another area of the campus and being used to develop new technologies which will continue to be researched and scaled up in the new facility.
“Once the facility is up and running in the new building, we’ll be able to immediately expand the current clinical trials,” says Dr. Zubair. “Then it’s time to take these technologies and develop them in a way in which we can get them to patients safely and quickly.”
The Life Sciences Incubator, within the Discovery and Innovation Building will commercialize discoveries from within the Mayo Clinic research labs and seeks to bring them to market quickly. It will also host life sciences companies from across the United States and around the world that could benefit from being co-located with Mayo Clinic resources on the Mayo campus.
“Expansion of our automation and cytoengineering capabilities in the Discovery and Innovation Building further positions Mayo Clinic as a trusted center of excellence in the regenerative medicine space,” says Atta Behfar, M.D., Ph.D., deputy director of translation for the Center for Regenerative Medicine across Mayo Clinic. “This transformative effort in Florida will allow development of novel therapies for patients who connect with us for hope and healing.”
Each Mayo Clinic campus has a unique set of regenerative medicine capabilities researching innovative solutions for patients. Together they form the Center for Regenerative Medicine, working as a whole to create new solutions to transform medicine and surgery.
This story first appeared on the Center for Regenerative Medicine Blog.
Tags: Abba Zubair, Atta Behfar, biomanufacturing, Center for Regenerative Medicine, discovery research, Innovations, lung transplant, Mayo Clinic Life Science Incubator, medical innovation, regenerative medicine, republished, stem cells