Regenerative Medicine Biomaterials and Biomolecules Facility
The Regenerative Medicine Biomaterials and Biomolecules Facility in the Center for Regenerative Biotherapeutics at Mayo Clinic: A current good manufacturing practice (CGMP)-compliant facility for synthesizing chemicals and building biomedical devices.
In the Regenerative Medicine Biomaterials and Biomolecules Facility, Mayo Clinic researchers create and manufacture novel materials and devices for first-in-human use. Innovations from the facility include implantable devices, tissue-engineered scaffolds and tendon repair lubricants.
Located at Mayo Clinic's campus in Rochester, Minnesota, the Regenerative Medicine Biomaterials and Biomolecules Facility provides resources to manufacture novel biomaterials, biomolecules and devices under current good manufacturing practice (CGMP). Its primary functions are chemical synthesis and device fabrication.
As a CGMP-grade laboratory, the Regenerative Medicine Biomaterials and Biomolecules Facility complies with regulations enforced by the Food and Drug Administration (FDA) and provides systems that ensure proper design, monitoring and control of manufacturing processes and facilities.
The Regenerative Medicine Biomaterials and Biomolecules Facility allows Mayo Clinic physicians and investigators to translate biomedical device research into patient care using internal resources in addition to traditional methods such as start-up companies and industry sponsors.
Regenerative medicine applications
The ability to provide regenerative applications to patients depends on translating innovations from the laboratory through CGMP commercialization. The Regenerative Medicine Biomaterials and Biomolecules Facility integrates the production of combination devices involving materials, cells and molecules, allowing faster translation of biomedical research and ideas to patient care.
Products synthesized and fabricated in the Regenerative Medicine Biomaterials and Biomolecules Facility are used to support early feasibility studies and first-in-human clinical trials. Products can also be used to support FDA-required preclinical studies for Investigational New Drug and Investigational Device Exemption applications to initiate clinical trials.
Products in development
Projects underway in the Regenerative Medicine Biomaterials and Biomolecules Facility include the following products:
The Regenerative Medicine Biomaterials and Biomolecules Facility places Mayo Clinic in the unique position of supporting biomaterials development and fabrication in an academic environment. Integration with other Center for Regenerative Biotherapeutics shared services — the Human Cellular Therapy Laboratories, the Regenerative Medicine Biotrust and the Advanced Product Incubator — allows the Regenerative Medicine Biomaterials and Biomolecules Facility to accelerate production of combination devices involving materials and molecules.
Platform leaders
The Regenerative Medicine Biomaterials and Biomolecules Facility is led by experts in biomedical engineering, orthopedics and neurology:
- Anthony J. Windebank, M.D.
- Cynthia E. Wilkins, Ph.D.
- Senior Director, Process Development
- Zachary T. Resch, Ph.D.
- Manager, Process Development
- Alan (Lee) Miller, Ph.D.
- Staff Scientist, Process Development