Preclinical drug testing
Researchers in the Advanced Product Incubator utilize cell counting instruments in preclinical laboratories. Cells are used to test the effectiveness of a cell-free regenerative product in development.
Liquid nitrogen storage
Cells and other raw materials are stored in extremely cold freezer tanks until ready for validation testing in one of the Advanced Product Incubator's preclinical labs.
Preclinical validation testing
Researchers in the Advanced Product Incubator perform quality control testing in biosafety cabinets. In this step, all products must meet preclinical release criteria to move forward.
Advanced Product Incubator
The Mayo Clinic Advanced Product Incubator is a manufacturing facility designed to accelerate discoveries into regenerative therapies for patients.
The Advanced Product Incubator co-develops and manufactures regenerative therapies that are cell-free and biologically based, following Food and Drug Administration safety regulations for current good manufacturing practice (CGMP). The Advanced Product Incubator is also compliant with the European Union's requirements for safe manufacturing of medicinal products.
Therapies manufactured in CGMP facilities are under strict control for consistent production and quality standards. By complying with these standards, the Advanced Product Incubator reduces risks of contamination in the therapies it manufactures, ensuring safe therapies for patients.
Cell-free, off-the-shelf therapies have the advantage of being immediately available, much like conventional medical therapies. Physicians and patients benefit from regenerative therapies without untimely and expensive treatment delays or return visits.
Using a team-based approach, the Mayo Clinic Advanced Product Incubator can manufacture an extensive array of treatments and devices for many diseases and conditions. Regenerative products from the Advanced Product Incubator help provide affordable treatment options for patients around the world.
New developments underway at the Advanced Product Incubator include treatments for:
- Heart disease
- Pelvic organ disease
- Plastic and reconstructive surgery
- Musculoskeletal disease
- Wound healing
In addition to product manufacturing, services available from the Advanced Product Incubator include project consultation and management, product testing and release, regulatory oversight, and product packaging and delivery.
Mayo Clinic Advanced Product Incubator
As part of the Center for Regenerative Biotherapeutics' shared services teams and facilities, the Advanced Product Incubator works closely with Mayo Clinic's researchers, scientists and physicians, such as those in the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program. Together, they're developing trusted regenerative solutions for patient care. The Advanced Product Incubator also welcomes collaborations with industry partners interested in developing regenerative solutions to address unmet patient needs.