WINSTON-SALEM, N.C. – March 31, 2017 – The Wake Forest Institute for Regenerative
Medicine (WFIRM) is
leading a five-year, $20 million effort to apply advanced manufacturing to
regenerative medicine. The goal 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
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, which was matched by a consortium of
regenerative medicine industry leaders and non-profit organizations.
“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
Under the MTEC award, WFIRM will focus on two projects. One is to
develop standardized “bioinks” 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 billions 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.
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 who are 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
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
collaborators Rice University and the Marcus Center for Therapeutic Cell
Characterization and Manufacturing at Georgia Tech, and industry partners Abbott
Vascular, FlowMatrics, Histogen, MilliporeSigma, Orthokinetic Technologies LLC,
Panasonic Healthcare, PepGel LLC, RoosterBio Inc., ThermoFisher and Tissue
Testing Technologies, LLC.