Regenerative Medicine Biomaterials and Biomolecules Facility
In the 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, a tissue-engineered scaffold, bioartificial organs and tendon repair lubricants.
The Biomaterials and Biomolecules Facility is a Current Good Manufacturing Practices (CGMPs) grade laboratory. CGMPs refers to regulations enforced by the Food and Drug Administration (FDA) and provides for systems that ensure proper design, monitoring and control of manufacturing processes and facilities.
The Biomaterials and Biomolecules Facility provides resources to manufacture novel biomaterials, biomolecules and devices under Current Good Manufacturing Practices. Its primary functions are chemical synthesis, device fabrication and 3-D printing.
The Biomaterials and Biomolecules Facility allows Mayo Clinic clinicians and investigators to translate biomedical device research into patient care using internal resources, rather than relying on traditional methods, such as start-up companies and industry sponsors.
The ability to provide regenerative applications to patients depends on translating innovations from the laboratory through CGMP commercialization. The 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.
The products synthesized and fabricated in the Biomaterials and Biomolecules Facility are used to support early feasibility studies and first-in-human, phase I and phase II clinical trials. Products can also be used to support the FDA-required preclinical studies for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to initiate clinical trials.
The Biomaterials and Biomolecules Facility places Mayo Clinic in the unique position of supporting biomaterials CGMPs in an academic environment. Integration with the other Center for Regenerative Medicine platforms — the Human Cellular Therapy Laboratory, the Regenerative Medicine Biotrust and the Advanced Product Incubator — allows the Biomaterials and Biomolecules Facility to support and accelerate production of combination devices involving materials, cells and molecules.
The Biomaterials and Biomolecules Facility is located in Rochester, Minnesota.
For more information, email the facility.