Researchers in bioengineering at the University of Notre Dame will join a consortium of academia, industry and government organizations and the nonprofit sector to develop next-generation manufacturing processes and technologies for cells, tissues and organs.
The Advanced Regenerative Manufacturing Institute (ARMI), Manufacturing USA initiative, will bring together close to 100 partner organizations as part of continuing efforts to help revitalize American manufacturing and incentivize companies to invest in new technology development in the United States. Approximately $80 million from the Department of Defense will be combined with more than $200 million in cost share to support the development of tissue and organ manufacturing capabilities.
Scientists at Notre Dame will focus on the challenges of advanced tissue biofabrication, as well as making current technologies and solutions available to patients in need. As part of the consortium, the university joins 47 industrial partners, 26 academic and academically affiliated partners, and 14 government and nonprofit partners. The ARMI will focus on accelerating regenerative tissue research and creating state-of-the-art manufacturing innovations in biomaterial and cell processing for critical Department of Defense and civilian needs.
Notre Dame researchers and bioengineers already direct several federally funded research programs in regenerative medicine through the colleges of science and engineering and in conjunction with the Notre Dame Center for Stem Cells and Regenerative Medicine.
“We’re looking forward to collaborating with this group of industrial and academic partners,” said Glen Niebur, professor of aerospace and mechanical engineering and director of the bioengineering graduate program at Notre Dame.
“Through our affiliation with ARMI, we have a great opportunity to contribute to making regenerative medicine products a reality.”
The ARMI marks the third Manufacturing USA institute that the university has partnered with, including LIFT (Lightweight Innovations for Tomorrow) and the Digital Manufacturing & Design Innovation Institute.
Significant breakthroughs in cell biology, biofabrication and materials science in the last decade have laid the foundation for large-scale manufacturing and commercialization of engineered tissues and tissue-related technologies, including tissues- and organs-on-chip. However, the tissue engineering field is fragmented and lacks a mechanism with which to turn laboratory breakthroughs into manufactured products. Therefore, the nation needs an industrial commons, in the form of a Manufacturing Innovation Institute within the federal NNMI network, in which to coalesce the field and provide a route for nascent product concepts to reach the marketplace. Bringing these products to the market will benefit critical U.S. public health needs and will provide the economic drivers needed to create new highly-skilled jobs.
Building an ARMI
The Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII) is sustained by the Advanced Regenerative Manufacturing Institute (ARMI), a non-profit organization located in Manchester, New Hampshire. ARMI will make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. To carry out its mission, the ARMI will integrate innovative cell and tissue cultures with advances in biofabrication, automation, robotics, and analytical technologies to create disruptive research and development tools and FDA-compliant volume manufacturing processes.
The overarching goal of ARMI is to establish a public-private partnership that will
- develop disruptive cell- and tissue-based technologies that will accelerate the discovery and characterization of novel small molecules and biologics,
- produce modular and scalable GMP-compliant manufacturing processes and integrated technologies across technology- (TRL) and manufacturing-readiness levels (MRL) 4-7,
- develop and standardize manufacturing best practices throughout the industry that are aligned with existing and evolving FDA guidance,
- close the skills gap in cell, tissue and organ manufacturing by providing training opportunities to undergraduates, graduates, veterans and non-college bound youth, and
- disseminate knowledge and enabling technologies to encourage continued innovation.
To achieve this goal, ARMI will bring together engineering, life science, computer science, materials science, manufacturing and workforce development expertise from industry, 2- and 4-year community colleges and universities, non-profit organizations, and local, state and federal government. A diverse, multidisciplinary consortium has been established.
Initially, ARMI will be supported by funding under the DoD-led Manufacturing Innovation Institutes program. During its first 5-7 years, ARMI will aim to become self-sustaining by spinning off companies, by providing contract development and manufacturing services, and by licensing technologies to its membership.
The Defense Department funded the 87-member coalition to develop next-generation manufacturing techniques for repairing and replacing cells, tissues and organs for wounded service members.
The Defense Advanced Research Projects Agency (DARPA) launched the Revolutionizing Prosthetics program with the goal of gaining Food and Drug Administration approval for an advanced electromechanical prosthetic upper limb with near-natural control that enhances independence and improves quality of life for amputees. In 2014, less than eight years after the effort was launched, the FDA approved the DEKA Arm System, invented by award-winning engineer Dean Kaman, who is leading the DoD Advanced Tissue Biofabrication Manufacturing Innovation Institute. DoD photo
Frank Kendall introduced the winning consortium — led by the nonprofit Advanced Regenerative Manufacturing Institute, headquartered in Manchester, New Hampshire, — whose industry, academic and government members will be part of the new Advanced Tissue Biofabrication Manufacturing Innovation Institute, or ATB-MII.
The institute is the 12th manufacturing hub awarded by the Obama administration, seven of them so far led by DoD.
“Manufacturing is deeply important to national security”
Manufacturing and National Security
Kendall noted that on December 19th DoD signed a technology-investment agreement with ARMI to establish the institute. More than 20 technical experts participated in the selection process and represented four federal government departments or agencies. DoD representatives included members of five military services and agencies, he added.
“This agreement, awarded by the Army Contracting Command, provides for seven years of operation with financial support supplied by a combination of $80 million in DoD funds and more than $214 million in non-federal cost sharing,” Kendall said. “This financial support offers ample evidence that industry is fully behind this initiative. This is truly a team effort,” the undersecretary said.
The Advanced Tissue Biofabrication team — organized by ARMI and led by engineer, inventor and entrepreneur Dean Kamen — consists of 47 companies, 26 academic institutions and 14 government and nonprofit organizations, all supporting the industry-driven nonprofit public-private partnership, Kendall said.
“It’s a real printing press — we’ll be printing 3D organs.”
“Members of the partnership include small through large businesses, DoD research and development laboratories, public and private universities, research institutions, federal and state government entities and local governments. Who are all collaborating to meet future defense and commercial requirements,” he added. ARMI will bring current and future members together in a collaborative space in Manchester, Kendall said, and “key state partners in the ATB-MII have pledged substantial support.” image
Researchers at Lawrence Livermore National Laboratory say the precision and 3D structures made possible through bioprinting are enabling them to more effectively reproduce human physiology outside of the body, which will eventually lead to a better representation of each tissue system that makes up the human body. They are New Hampshire, Massachusetts, Connecticut, Ohio, Wisconsin, Minnesota, Indiana, North Carolina, Florida, Tennessee, Texas, California, Colorado, Washington, Arizona, New Jersey, Pennsylvania, New York and Maryland. “I don’t think you want to be left out of this activity,” Kendall said.
The ATB is an investment in manufacturing and testing technologies to advance the state of the art in regenerative medicine, the undersecretary said.
“The ‘why’ for this institute is one that is extremely important to all of us and personal to many of us in the Defense Department — restoring form, function and appearance for our wounded warfighters and changing what is possible for the many Americans who’ve spent far too long on the organ-transplant waiting list,” he added.
The institute encompasses state-of-the-art tissue manufacturing, cell and biomaterial processing, 3-D bioprinting, automation and nondestructive testing technologies, Kendall said.
“The biggest challenge to widespread availability for emerging manufacturing tissue products is in common technologies, processes and standards to advance manufacturing, product testing, quality control, quality assurance and product preservation,” the undersecretary said.
Cells, Tissues, Organs
It’s necessary, Kendall said, to create and sustain an industrial commons — a foundation of knowledge and capabilities — “for the ATB-MII to advance the standardization of tissue products and processes for widespread use across industries in areas such as cell therapies, engineered replacement tissue and biopharmaceutical products.”
Scaling up manufacturing processes to produce cells, tissues and organs at scale “will catalyze disparate supply-chain elements and enable novel products for the Defense Department and the larger health-care sectors,” he added.
The challenge is amplified in medicine, Kendall said, because of the complexities of scaling and especially the unique nature of tissue engineering. image video
From Science to Industry
Kamen’s inventions include the Segway human transporter, the first drug-infusion pump, portable dialysis machines, a water purifier, an all-terrain electric wheelchair and, working with the Defense Advanced Research Projects Agency, the DEKA-Luke prosthetic arm.
About the arm technology, now approved by the U.S. Food and Drug Administration, Kamen described it at the White House as, “making arms for some of these young [military] heroes who desperately need and deserve something more than a stick with a hook on it.”
Describing the job of developing the infrastructure scientists need to turn their science into products for people who need them, Kamen said, “We can supply essentially what the printing press did to get all these ideas to the world that needs them. We need to essentially make the printing press for the world of regenerative medicine. It’s a real printing press — we’ll be printing 3D organs.”
And that’s not just an analogy, Kamen added, Kidneys, he said, may be one of the first organs to be produced. The inventor said he and his team of engineers will give the scientists the tools they need to turn what is now an incredibly exciting science into an industry “that will meet the needs, first of your soldiers who need skin for burns and organs because of what they lost, but then the rest of the country and the rest of the world will benefit.”