Facilities

The Center for Regenerative Biotherapeutics comprises 50,000 square feet of state-of-the-art research and biomanufacturing space, including 15 International Standard for Organization (ISO)-classified clean rooms across Mayo Clinic’s campuses in Arizona, Florida and Minnesota. These facilities meet strict quality controls and regulatory guidelines that are required for manufacturing new biologics.

Arizona — Support Services Building: Biomanufacturing

The Support Services Building on Mayo Clinic's Campus in Phoenix, Arizona, includes a single 220-square-foot cleanroom and Current Good Manufacturing Practice (cGMP) infrastructure. This space complements the development of cell therapies and is adjacent to a human cell therapy lab. This facilitates preparation of mesenchymal stem cells and bone marrow transplant materials.

This facility:

• Is classified as ISO 7 and Class 10,000.
• Supports manufacturing for phase 1 and 2 trials.
• Complies with all applicable U.S. Food and Drug Administration (FDA) and European Union (EU) regulations.
• Includes dedicated 3D printing and electrospinning technology.

Florida — Discovery and Innovation Building: Biomanufacturing

At Mayo Clinic's campus in Jacksonville, Florida, Center for Regenerative Biotherapeutics facilities include a 1,500-square-foot ISO 7-8 clean room and cGMP infrastructure. The space is designed for automated cell manufacturing and can support multiple simultaneous cGMP manufacturing processes.

The Discovery and Innovation Building's three independent cGMP manufacturing spaces:

• Are classified as ISO 7 and Class 10,000.
• Support manufacturing for phase 1 and 2 trials.
• Comply with all applicable FDA and EU regulations.

Florida — Human Cellular Therapy Laboratory: Processing and biomanufacturing

The Human Cellular Therapy Laboratory on Mayo Clinic’s campus in Florida provides a diverse portfolio of services to support the conception, development and execution of regenerative biotherapeutics clinical trials. The laboratory is fully equipped to perform processing and cGMP manufacturing of cellular or cell-derived products from various tissue types. It uses state-of-the-art technological platforms for isolation, expansion and characterization of stem cells and other cellular and acellular products.

The lab’s service lines include:

• Cell characterization.
• Cell manufacturing.
• Cell processing.
• Extracellular vesicle (EV) manufacturing.
• Product preparation and distribution to clinical sites.

Its product capabilities include:

• Allogeneic bone marrow-derived mesenchymal stem cells (BMSCs).
• Allogeneic adipose tissue-derived mesenchymal stem cells (ADMSCs).
• EVs derived from BMSCs.
• EV-derived ADMSCs.
• Engineered mesenchymal stem cells (MSCs) and EVs.
• Preclinical MSCs and EVs for use in product development, validation and experimental research.

Minnesota — Hilton Building Laboratory: Biomanufacturing

The Hilton Building Laboratory is a 10,000-square-foot cGMP facility. It is dedicated to the manufacture and delivery of cells as "living drugs" to provide hope for Mayo Clinic patients. It includes:

• ISO 5-classified biological safety cabinets for critical cell processing.
• ISO 7-classified direct manufacturing support space.
• ISO 8-classified indirect manufacturing support space.
• Extensive liquid nitrogen storage.

The Hilton Building Laboratory’s product capabilities include:

• An allogeneic MSC bank.
• Dendritic cells.
• Chimeric antigen receptor (CAR)-T cells.
• MSCs.
• MSCs plus chondrons.
• MSCs plus matrix.

Minnesota — One Discovery Square: Biomanufacturing

The Center for Regenerative Biotherapeutics has 4,500 square feet of manufacturing space in One Discovery Square on Mayo Clinic's campus in Rochester, Minnesota. The space contains five independent cGMP clean rooms compliant with FDA and European Medicines Agency regulations. These facilities:

• Are classified as ISO 7 and Class 10,000.
• Support manufacturing for phase 1 and 2 trials.
• Include on-site logistics and material traceability.

The center's One Discovery Square infrastructure supports multiple simultaneous cGMP manufacturing projects and includes auxiliary advanced product incubator space. The standard fit-out is for cellular and acellular manufacturing, while enhanced scalability with bioreactors accommodates larger patient bases and broader therapeutic applications. The building's dedicated water system supports an industrial-sized autoclave for cleaning and sterilization.

One Discovery Square's product capabilities include:

• CAR-T cell therapy-based manufacturing.
• Cell banks.
• Lyophilization for advanced product preservation.
• Nonviral gene therapies.
• Purified EVs.

Minnesota — Two Discovery Square: Process development and quality control

The Center for Regenerative Biotherapeutics has 15,000 square feet of designated space in Two Discovery Square at Mayo Clinic's campus in Minnesota. Process development space in this building is designed to translate regenerative biotherapeutics concepts, including cellular and acellular therapies. Meanwhile, the center’s biomanufacturing experts deliver samples from One Discovery Square and the Hilton Building Laboratory for quality control testing in Two Discovery Square. After testing, the center releases products to treat patients.

All spaces in Two Discovery Square follow FDA manufacturing regulations, including controlled access to all doors. And although the Two Discovery Square facilities are in a leased space, the Center for Regenerative Biotherapeutics owns its own heating, ventilation and air-conditioning system and support equipment.

Process development

In Two Discovery Square, center experts create procedures to take discovery science through to cGMP manufacturing. This includes developing protocols for manufacturing cellular, acellular and bioprinted biotherapeutic products. Scaled cell manufacturing capabilities and specialized analytic development allow for final product testing.

Pilot plant

Two Discovery Square includes an ISO clean room simulation environment to facilitate technology transfer from process development to cGMP manufacturing. The space provides a cGMP-like environment for scientific leaders, procedural developers and biomanufacturing operators to better understand process feasibility in a clean room environment. It is not designed to produce materials for human use. Rather, it enables staff training and production of sample articles for safety trials and definitive preclinical testing as part of the FDA submission process.

Quality control

The facility’s quality control team ensures consistency, safety and efficacy of novel biotherapeutic products by allowing experts to examine the following product elements:

• Identity. Center technologists use flow cytometers to verify cell markers for cell-based therapies.
• Purity. Staff members ensure purity with quantitative polymerase chain reaction to measure levels of contaminating DNA and with endotoxin analyzers to assess endotoxin levels.
• Potency. Spectrophotometers and plate readers quantify the activity of bioactive compounds.
• Safety. The facility’s mycoplasma detection system screens for mycoplasma contamination.
• Sterility. A sterility testing incubator ensures an environment to confirm the absence of viable microorganisms. This includes Bact/Alert, an automated, sensitive, rapid technology to detect microbial contamination.
• Environmental contamination. The center's environmental monitoring involves surveilling critical areas, such as ISO 5 and ISO 7 clean rooms, to detect viable contamination, such as bacteria or fungi, as well as nonviable contamination such as particulate matter. Environmental monitoring is not a direct test on the product, but by maintaining a controlled environment, it plays a vital role in upholding sterility and safety. It ensures that the production environment meets the required cleanliness standards.

Quality assurance

The Center for Regenerative Biotherapeutics maintains a robust quality system to ensure products and services meet safety, quality, identity, purity and potency requirements. Aligned with FDA guidance, the quality assurance protocols conducted in Two Discovery Square provide independent oversight across:

• Raw materials.
• Finished products.
• Production areas.
• Documentation.
• Training.
• Validation.
• Qualification equipment.
• All methods and systems supporting manufactured products.

Quality assurance ensures records conform to applicable laws, internal procedures and product specifications.