12 September 2017

Members of both the Board of Directors and Stakeholders Council of BioFabUSA gathered for a ribbon-cutting ceremony during the grand opening of the Advanced Regenerative Manufacturing Institute's research facility in Manchester, New Hampshire, July 28. Photo courtesy of Steve Lipofsky
Advanced Regenerative Manufacturing Institute Opens Its Doors to the Future
Jeffrey Soares, USAMMDA public affairs
Amid an enthusiastic crowd of more than 400 attendees, the Advanced Regenerative Manufacturing Institute celebrated the start of its operations during an open house at its research facility in Manchester, New Hampshire, July 28. In 2016, ARMI was awarded the BioFabUSA effort, which is a Department of Defense-sponsored initiative in the Manufacturing USA network, and the first to address biomanufacturing. The BioFabUSA program looks to bridge the gap between early scientific research and later-stage product development by advancing critical technologies to enable large-scale biological manufacturing efforts.

With many attendees traveling from across the nation, more than 25 states were represented at the historic event, and corporate participation included 60 companies primarily from the biomedical and biotechnology fields. This past year, the DOD awarded $80 million in funding to ARMI through BioFabUSA; industry partners, many of whom joined in the launch celebration, pledged an additional $214M. The DOD's investment in this project rests primarily in its great potential to benefit Warfighters who may return home with catastrophic injuries.

Kristy Pottol, project manager of the U.S. Army Medical Materiel Development Activity's Tissue Injury and Regenerative Medicine Project Management Office, clearly sees the multitude of advancements throughout both military and civilian medicine this project may provide. As the lead DOD agent representing the U.S. Army Medical Research and Materiel Command, the program manager and member of the Stakeholders Council, Pottol is helping to guide this effort and has been involved with the project from the very beginning.

"Without a doubt," said Pottol, "I fully expect this program to help accelerate the delivery of critical products to our Warfighters, whether it's a replacement part or a small piece of necessary technology that may be hindering a product from being delivered to the battle space."

"The point of BioFabUSA, and what ARMI is driving," she continued, "is to bring together industry, academia and government to work on problems that are more difficult than any one institution alone can solve."

Pottol explained that ARMI's goal is to be self-sustaining in five to seven years by spinning off new companies, providing contract development and manufacturing services, and licensing technologies to membership participants.

The main thrust of BioFabUSA is to create an "industrial commons" to help promising new products reach the marketplace through a unification of knowledge, materials and equipment that may be shared between large and small organizations.

John Getz, BioFabUSA deputy program manager and TIRM PMO product manager, sees this project as a tremendous opportunity to advance the field of tissue engineering, as well as other related areas of biomanufacturing.

"This effort is really about encouraging partnerships to create critical products," said Getz. "If a small company with the technical capability can be connected to a large company with the ‘exquisite' tools and equipment, together they could bring a valuable product to market."

Getz believes this model will be a strong catalyst for collaborations that will lead to innovation.

"Using this plan and this facility, people can now come together with their ideas, walk across the hall and utilize technologies that may be unaffordable or unattainable at their home institutions, develop the product, and then go back to their own institutions and continue their research," he said.

As part of the event activities, multiple technology demonstrations — including a state-of-the-art 6-axis three-dimensional printer — were offered in various areas of the ARMI facility. Getz said these displays were intended to engage both the casual onlooker as well as the invited scientists interested in tissue engineering.

"What we hoped to do with these demonstrations," he explained, "was to take technology from adjacent spaces to modify or invent new tools or technologies — or new operating processes — and bring this directly to the bioengineers, to show them what this type of high-level equipment could do to advance their biological tissue constructs."

Getz said they would also use the feedback provided by the guests to identify competencies within the space that currently do not exist.
Although the BioFabUSA model is intended to open up a new world of knowledge- and technology-sharing across a wide variety of disciplines, both Pottol and Getz are hoping for huge results in the field of tissue engineering and regenerative medicine. Given the TIRM PMO's recent success in the field of Vascularized Composite Allotransplantation, which involves hand and face transplants, it is not surprising that the two remain heavily invested in the outcome of ARMI's new venture, especially as it relates to the Warfighter.

However, it is understood that a great deal of work lies ahead for all participants.

Said Getz, "The technology surrounding the development of an ‘OEM' [original equipment manufacturer] human organ is certainly the hard part, but the standardization and automation of the process shouldn't be, and this is where BioFabUSA can help — but to do this, we have to start planning today. We need to think about the full, finished product right from the initial design. Many lab companies, when technology is early at the bench, are not thinking about full-scale manufacturing — but they really need to be."

"BioFabUSA is not designed to create the end product," he continued. "Its job is to help others with whatever they need to create the end product, be it knowledge, technology, equipment, process streams — anything needed to address the challenges currently seen in the field."

Planning ahead remains a critical component of BioFabUSA's future success, and Getz emphasized the importance of "road mapping" as the team heads towards the future.

"Our first task is to determine the road blocks that are preventing scale-up of viable products," he said. "If your product is actually safe and effective, in terms of FDA [U.S. Food and Drug Administration] approval, then what are the things holding you back from actually delivering?"

Pottol explained that to be effective, the process must also be iterative and repeated often. It must follow an agile methodology, where solutions come from true collaboration.

"Our plan is to bring people together, hammer out part of the problem and part of the solution, iterate it, and then come back around and do the same again until the problem is resolved," she said.

The idea of collaboration returns as the two speak of the vast potential of the BioFabUSA mission. This project is not about multiple teams racing towards a finish line, hoping to jump ahead of each other in the final stretch. It's more akin to an obstacle race, where talented individuals work closely together to reach the goal, doing everything possible to ensure the team does not falter along the way.

The launch of ARMI's new facility was much more than the opening of a physical building, or a workspace; it was an opportunity for those gathered to view firsthand the members of an extended team — their team — all hoping for the same positive results.

"We fully expect that BioFabUSA will function as a tremendous force multiplier," said Pottol. "Everyone involved will be better off in working together towards a common goal."

Added Getz, "This technology must be made available to anyone or any group that needs it, small or large."
Through the efforts of ARMI and BioFabUSA, the potential for growth, innovation and achievement in science and medicine is extraordinary — which certainly is a great beginning for a truly significant endeavor.
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