Establishing a Current Good Manufacturing Practice Facility for Biomaterials and Biomolecules in an Academic Medical Center

A major hurdle in translating biomaterial-based products is moving from the laboratory into first-in-human trials. For many investigators, this is difficult to achieve without industry assistance. A biomaterials facility that follows current good manufacturing practices (cGMPs) in an academic medical center would potentially accelerate the process of translating biomedical products to first-in-human trials. This article details the establishment of Mayo Clinic's Biomaterials and Biomolecules cGMP facility and the challenges encountered in creating a manufacturing facility in an academic medical setting. The facility functions as a platform for manufacturing and as a resource for guiding investigators from discovery through translation. The success of the facility relies on addressing challenges associated with balancing the volume of requests for cGMP services and the facility's capacity by prioritizing projects in the pipeline. In addition, we will educate researchers regarding the methodologies used in carrying out their preclinical projects such that the data generated are appropriate to support an Investigational Device Exemption application to the Food and Drug Administration.