The Center for Regenerative Medicine Biomaterials and Biomolecules facility, one of four board-designated regenerative medicine platforms, is now available to Mayo Clinic clinicians and investigators looking to manufacture clinical-grade products in a cleanroom space. The new facility positions Mayo Clinic to be a leader in regenerative technologies by allowing faster translation of biomedical research and ideas to patient care.
The facility is an approximate 1,000-square-foot space built to support the manufacturing of novel biomaterials, biomolecules and device fabrication under current Good Manufacturing Practices (cGMP). cGMP refers to regulations, enforced by the U.S. Food and Drug Administration (FDA), that assure proper design, monitoring and control of manufacturing processes and facilities. This type of laboratory environment permits first-in-human use of novel materials and devices, including implantable devices, tissue engineered scaffold, bio artificial organs and tendon repair lubricants. The products synthesized and fabricated in this facility will be used to support early feasibility studies and first-in-human/Phase I/Phase II clinical trials.
“We’re excited about the new cGMP Biomaterials and Biomolecules Facility at Mayo,” says facility co-director Anthony Windebank, M.D. “It will enable Mayo clinician-researcher teams to synthesize and/or fabricate devices for first-in-human trials.”
Dr. Windebank and co-director Michael Yaszemski, M.D., Ph.D., have collaborated on tissue engineering projects for 10 years. “This is now the time to bring this lab-based research into the clinic to meet the unmet needs of our patients,” says Dr. Windebank.
Biomaterials and medical devices are widely used in human applications as diverse as heart valves, hip joints, pacemakers, tooth implants, drainage shunts, intraocular lenses, and heart-assisted devices. They save lives, improve the quality of life for millions, and form the basis for a strong, successful regenerative medicine program.
The Biomaterials and Biomolecules team also provides support functions, including:
- Project Readiness/Consultation
- Product Development
- Regulatory Facilitation/Advice
- cGMP Manufacturing
- Product Testing and Release
“This is unique for an academic institution and provides the opportunity to bring novel therapies to our patients to meet unmet needs as rapidly as possible,” Dr. Windebank adds. “The facility will also provide consultative support to help investigator teams through the difficult and complex process of bringing a discovery into the clinic for the first time.”
Although located in Rochester, the Biomaterials and Biomolecules Facility serves all Mayo Clinic locations, and is integrated with the other platforms supported by the Center for Regenerative Medicine: Regenerative Medicine Biotrust, Human Cellular Therapy Laboratories, and the Advanced Product Incubator.
For More Information
The Center for Regenerative Medicine has a Question and Answer section on the Biomaterials and Biomolecules Facility website.
For more information, email the Biomaterials Facility or call (77) 4-4819.
Learn more about the available services at the Biomaterials and Biomolecules Facility in this video.