The Wake Forest Institute for Regenerative Medicine (WFIRM) is leading a $20 million effort to apply advanced manufacturing to regenerative medicine.

The goal of the five-year program is to speed up the availability of replacement tissues and organs to patients.
“We are excited to be at the forefront of this next frontier in regenerative medicine,” said Anthony Atala, M.D., director of WFIRM, which is part of Wake Forest Baptist Medical Center. “Just like the invention of the moving assembly line reduced the cost of cars and made them commonplace, the field of regenerative medicine must develop standardized manufacturing processes to successfully make replacement tissues and organs more widely available.”

Public-private partnership provided funding

A public-private partnership that involves the U.S. Army Medical Research and Materiel Command awarded the project. The goal of this partnership, known as the Medical Technology Enterprise Consortium (MTEC), is to accelerate progress in regenerative medicine manufacturing. MTEC awarded $10 million for projects WFIRM will perform. The funding was then matched by a consortium of regenerative medicine industry leaders and non-profit organizations.

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“Regenerative medicine therapies are already benefiting small groups of patients through clinical trials,” said Atala. “While there is still much to accomplish scientifically, the field is at a tipping point. If we are going to bring high-quality, cost-effective therapies to patients, now is the time to begin the important work of developing the manufacturing processes. Collaboration between industry and academic researchers increases the chance of success.”

Under the MTEC award, WFIRM will focus on two projects. One is to develop standardized “bio-inks” that can be used to print replacement tissues and organs. The second is to develop standardized cell culture media — liquids that support cell growth. These products are used in most all regenerative medicine projects because of the millions of cells that must be grown for each patient.

The results of these efforts – when combined with other MTEC-funded projects – will help to build a library of proven processes and materials that can be used by researchers and regenerative medicine companies. Access to this information will help standardize the manufacturing process and help speed up the approval of new therapies.

Two entities oversee research, collaboration

WFIRM has founded a non-profit organization to conduct research to advance regenerative medicine manufacturing, the RegenMed Development Organization, which is the recipient of a $10 million MTEC award. To facilitate collaboration between industry and academia, WFIRM also founded the Regenerative Manufacturing Innovation Consortium (RegMIC), which matched the MTEC award. The consortium has 40 members, including not-for-profit organizations, academic, and regenerative medicine industry leaders. The group’s goal is to help ensure a smooth transition of new therapies to market, which includes working with government agencies to develop standards and address regulatory challenges.

WFIRM has also developed a “roadmap to manufacturing” for the regenerative medicine industry that identifies changes that must be addressed, including the need for standardized products, taking advantage of economies of scale, developing standardized operating procedures and quality measurements.

RegMIC members involved with the MTEC project are: academic partners Georgia Tech and Rice University, and industry partners Abbott Vascular, Flow Matrics, Histogen, Millipore Sigma, Panasonic, ThermoFisher and Tissue Testing Technologies, LLC.

(C) N.C. Biotechnology Center