Translating discovery into healing

With a focus on accelerating the clinical translation of new biotherapies to early-phase clinical trials, the Mayo Clinic Center for Regenerative Biotherapeutics' new Biomanufacturing Process Development Facility supports the development of cell and gene therapies and tissue engineering. The facility transforms early-stage discoveries into advanced, patient-ready biotherapies by pairing research environments with a controlled, clinical-scale processing facility.

Located within the second phase of the Discovery Square development and adjacent to Mayo Clinic's downtown campus, the facility serves as a hub for training the next generation of clinicians and scientists. Research, development, industry engagement, and education come together within a single, dynamic environment.

The design features a clean aesthetic with branded colors integrated throughout, creating a cohesive and inspiring setting. Transparent, daylight-filled laboratories foster connection and visibility while supporting complex biomedical research and development.

The facility includes state-of-the-art process development laboratories, tissue culture and engineering areas, an ISO 7 GxP Suite, quality control laboratories, high-density cold storage, and collaborative workplace and tenant amenities. Mayo Clinic consolidated its main campus quality control operations to this location, placing this critical capability directly alongside the process development labs.

Additional tenant space within the adjacent One Discovery Square building accommodates supplemental controlled storage, GMP/GxP kitting, and shipping operations, providing seamless operational support for complex, multi-modality product development and manufacture.

A defining feature of the facility, the GxP Suite supports the processing of FDA-compliant patient therapies for clinical use within the same location. This integrated approach streamlines process scale-up, supports organizations transitioning from research to clinical or pilot-scale work, and delivers robust cGMP capabilities within a flexible, scalable planning framework.