The grand opening of One Discovery Square opens a new chapter in biomanufacturing focused on connecting patients with complex medical conditions with novel biotherapeutic solutions.

The Mayo Clinic Center for Regenerative Medicine Advanced Biomanufacturing facility is one of the Mayo tenants in the building focused on the acceleration of new health care products to market by partnering innovation with industry.

When it is fully up and running in One Discovery Square, the facility will seek to develop first-of-their kind therapeutic products, and together with industry collaborators, move them quickly from the bench to the bedside for Mayo patients and then others around the world.   

A new era of regeneration, biomanufacturing harnesses biomaterials and biomolecules for use in medicine. The resulting new generation of health care products has the potential to bring new treatment options to patients.

“In biomanufacturing, technologies have historically come with significant cost of manufacturing,” says Atta Behfar, M.D., Ph.D., a cardiologist and deputy director of translation for the Center for Regenerative Medicine. “Forged with the vision of industry collaboration, the goal for Discovery Square is to establish transformative biomanufacturing platforms that will ultimately connect patients with untreatable conditions with accessible curative technologies.”

The Center for Regenerative Medicine Advanced Biomanufacturing facility is led by Dr. Behfar and Andre Terzic, M.D., Ph.D., the Michael S. and Mary Sue Shannon Director, Mayo Clinic Center for Regenerative Medicine.

“The effort in One Discovery Square will allow us to forge an ecosystem of innovation by partnering with industry to establish next generation regenerative technologies at Mayo Clinic. With a focus on scaled and targeted biomanufacturing platforms, the acility is poised to establish new regenerative tools adapted for rapid integration into practice,” says Dr. Terzic.

Biomanufacturing in Patient Care

There are many implications of biomanufacturing in health care. The Mayo Clinic Center for Regenerative Medicine is leading several efforts that will advance patient care, including:

• Cellular and gene therapy: These two types of therapies offer therapeutic intervention for a range of diseases for which relatively limited clinical options are currently available. Cellular therapies contain cells or tissues derived either from a donor or a person’s own stem cells that employ healing through replacement of function. Gene therapy is the addition of new genes to a patient’s cell to replace missing or malfunctioning genes that are driving disease.
• Acellular technology: Acellular — or cell free — technology are biologics that are termed “off-the-shelf.” It means they can be manufactured and stored for long periods of time right at the hospital, as opposed to needing to be frozen, thawed and brought to a patient.  Cell free products are less generally expensive for patients and can be used more widely.
• Tissue engineering: The goal of tissue engineering is to assemble functional constructs that restore, maintain, or improve damaged tissues or whole organs using scaffolds, cells and biologically active molecules. Tissue engineering uses new approaches to repair, restore or regenerate tissue function lost due to injury, chronic disease and aging.

Biomanufacturing Challenges

One of the challenges in biomanufacturing is having the proper technology and production capabilities in place to meet rigorous standards for U.S. Food and Drug Administration (FDA) approval.  A key component of that is the highly regulated Current Good Manufacturing Practices (cGMP) laboratory needed to research and produce these new products, such as cellular and acellular therapies, pharmaceuticals, medical devices, and engineered tissues. The Center for Regenerative Medicine Advanced Biomanufacturing facility will feature cGMP lab space, which is important to assure proper design, monitoring, and control of manufacturing processes and follows cGMP regulations established and enforced by the FDA.

“One Discovery Square provides a central location to develop, translate and apply new biologics that are unique to Mayo Clinic,” says Dr. Behfar.  “Our goal has always been to get the latest technologies to patients quickly.”

Tags: Advanced Biomanufacturing Facility, Biomanufacturing, Discovery Square, DMC, Dr. Andre Terzic, Dr. Atta Behfar, Mayo Clinic Center for Regenerative Medicine, News, regenerative medicine