Advanced Product Incubator Capital Equipment
Biobusiness Grant Recipient: Dr. Atta Behfar, MD, PhD
Grant Period: 2015-2016
Site: Center for Regenerative Medicine | Mayo Clinic | Rochester, MN
Regenerative medicine is a branch of medicine that focuses on the rejuvenation, replacement, and regeneration of human cells, tissues, and organs in a way that reestablishes or restores normal function. A substantial portion of regenerative medicine research uses stem cells because they have the ability to develop, or differentiate, into many different types of cells.
Specific molecules within stem cells trigger growth of new tissue. While stem cells hold a great deal of promise in regenerative medicine research, they are often costly and too individualized for general use.
A “lab within a lab,” Mayo Clinic’s new Advanced Product Incubator (API) features sophisticated air monitoring and particle-filtering equipment that eliminates nearly all air particles, creating a super-hygienic environment situated immediately next door to adjoining office workspace. The state-of-the-art technology contained within this environment facilitates the production of medical and surgical therapeutic products manufactured specifically for use in regenerative medicine.
API occupies 3,000 square feet of laboratory and office space on the third floor of the Minnesota BioBusiness Center in downtown Rochester, MN. Rather than traditional sheet rock and framing, the inner walls of the API units are constructed from clean, dust-free aluminum core that prevents particles from entering the air space. To further reduce the number of particles in the clean space, all workers entering the API clean rooms wear head-to-toe Tyvec lab garments.
The greatest feature of the Advanced Product Incubator is its ability to clean air. An API removes nearly every particle from the air space, to the point of single particle counts. In comparison, ordinary air in a similar sized space can contain as much as 35 million particles. The facility includes two separate clean rooms, which allows for dual and simultaneous production.
The facility also houses the Sepax 2 RM cell separation system, typically used in regenerative medicine for bone marrow and cord processing. Researchers use the Sepax 2RM system to separate cells in a fully automated and secured environment, virtually eliminating operator error in the ultra-clean atmosphere of the API in the process.
Scientists use the Sepax 2 RM cell separation system to isolate and use the growth-triggering molecules rather than the entire stem cell to create new therapies for conditions that were previously untreatable. Isolating these cell-free therapies helps researchers and manufacturers develop “off-the-shelf” drugs that regenerate missing or damaged tissue, saving lives and improving the quality of life for patients with serious medical conditions.
The state-of-the-art office building housing the API facility was constructed according to Current Good Manufacturing Practices (CGMP) established by the Food and Drug Administration (FDA) and European product safety standards. The API adheres to the highest standards of facility design, monitoring, and process control. This unique design of the API facility even earned the FDA's Certified Good Manufacturing Practices designation.
Regenerative Medicine Minnesota and the API bring state-of-the-art medical technology and new business opportunities to those living in Minnesota; the multidisciplinary facility of API is the first of its kind because it accelerates product development by bridging teams of physicians and researchers with industry and science experts. The design of the API facilitates the transition from laboratory discovery to clinical-grade curative products. This means the API can help bring new, more efficient, and safer lifesaving drugs to market faster than ever before.
Dr. Atta Behfar is the Director of Cardiovascular Medicine at Mayo Clinic with expertise in the development of bedside-to-bench models utilizing high-throughput technologies for bioassay development and discovery of regenerative biologics. Behfar earned his MD and PhD from Mayo Clinic in Cardiovascular Stem Cell Biology and Pharmacology.