Can the state hold on to the biofabrication ‘jewel’ emerging at ARMI?

There’s a room at 400 Commercial Street in the Manchester Millyard called the Tissue Foundry. Here, the Advanced Regenerative Manufacturing Institute, or ARMI, is growing human cells into body parts. On a small assembly line, a vial of frozen cells gets thawed and bathed, and the cells are separated and added to a growth solution. After working their way down the line — with volumes of data collected at each step — they are given chemical instructions to grow into a specific body part, such as an anterior cruciate ligament, or ACL. At the far end of the line, there is rack of finished ACLs, ready for a partner clinic to install in a human knee and rescue the career of a high school athlete or simply prolong the hoop dreams of a middle-aged weekend warrior.

This is not science fiction. This small lab, which could be run by a technician with a training level equivalent to a traditional manufacturing job, is right now being scaled up into a much larger series of production lines just down the street, a 27,000-square-foot biofabrication factory at 540 Commercial Street.

That space, according to ARMI, will be up and running by early 2022 — or sooner.

And even that will be just the beginning. Because the end game, the grand plan inventor Dean Kamen has for ARMI, is to make Manchester and its surrounding communities the hub of a predicted global biofabrication boom — the regenerative manufacturing equivalent of Silicon Valley.

ARMI is seen as being the hub of an ecosystem of businesses that support scalable, cost-effective manufacturing of human tissues, including the actual tissue manufacturers — a company that makes lungs, for example — but also the companies that make the containers you’d use to keep the lungs alive in transport; existing hospitals or new medical facilities that might customize and bring in specialists to do the transplants, so the organs don’t need to be transported over long distances; and the software companies, sensor companies, testing companies and even farms that might supply test animals.

All that is empirically much more possible, in Kamen’s opinion, than it was when ARMI began in 2017. But it’s also a dream at much greater risk of being absconded with by other cities, states or institutions.

“I am very concerned this community simply does not know what a little jewel they have over there. They should be excited, they should be proud, they should be doing everything they can to nurture this thing, so that they don’t lose the opportunity to transform the local and regional economy,” Kamen said.

What’s truly at stake

That transformation has already begun, though it has yet to reach the critical mass Kamen and the team at ARMI believe is necessary to ensure that some other institution, in some other state, doesn’t piggyback on the groundbreaking conceptual work ARMI has already done and create the biofabrication hub elsewhere.

He believes that, though the rest of the biotechnology and regenerative medicine community worldwide is paying close attention to what ARMI’s up to, the community in New Hampshire doesn’t have the information it needs to understand what’s truly at stake.

Kamen says the challenge is that ARMI itself doesn’t have a sales and marketing unit. “We’re a bunch of technology people, engineers. There’s almost no direct reason to be talking to the local public.”

On the other hand, without that local excitement providing grassroots impetus for public support in Manchester and throughout the state, the natural advantages New Hampshire has for locating the hub may be outweighed by the spending capabilities of richer states and institutions.

In the best-case scenario, Kamen says, the people of the state “would be pushing the city and state government to do whatever they could to attract and let the companies, individuals, students and investors know that we really love you and want you here. Other states just buy them, give them all sorts of things. But this little state, they don’t have that kind of money, and frankly it’s not appropriate, not part of the ethos or philosophy of this little state to do that.” And while he cites strong support from New Hampshire leaders, he feels more needs to be done.

Getting the initial funding for ARMI to launch Kamen’s project, which he admits, “even for me was crazier than most,” was no foregone conclusion. ARMI competed against 59 other institutions to get its first $80 million grant from the Department of Defense to create the BioFabUSA program. Industry partners then committed to $214 million more.

The technology challenge was to take a process that up until that point seemed possible at a radically small scale “in a petri dish” or “artisan” level, Kamen says, and turn it into mass production.

“When there’s a waiting list of a few hundred thousand people, 20 or 25 percent of which are going to die waiting for their kidney or their liver or their lung, doing them one at a time ... grandma makes great chicken soup, but if the whole country needs soup, we need Campbell’s; we need cans.”

In order to scale that “miracle in a petri dish” into large-scale production, a huge number of partners across many scientific, engineering and manufacturing disciplines have also needed to buy in.

Meeting those challenges was a “difficult, high-risk, shoot-for-themoon proposition, that has a reasonable chance of not working over any reasonable period of time with any reasonable amount of resources,” Kamen admits.

And yet it did work.

According to Kamen, “In the first couple of years, a bunch of things changed. We didn’t get a few dozen interested people — we got 170. And we got world-class clinical institutions. And I would say over a couple-of-year period, to me what changed was where the big risk is.”

The “entire risk” right now “is no longer, ‘will we have regenerative organ manufacturing?’ That’s almost a guarantee. The risk we now have is, when it gets to any scale, will all of it or a substantial piece of it — or, God forbid, any of it — end up in New Hampshire?”

Why New Hampshire?

Kamen’s concern is balanced by what he says are a load of good reasons New Hampshire makes sense as the seat of this new industry.

He points out that while New Hampshire can’t compete with New York, Texas or California by throwing money at things, “we can compete because we’re nimble, we’re fast, we’re hopefully a well-connected small community where we can go to our senators and say, ‘This is what we need,’ and we’ve done that. They brought us more money. We go to our governor and say, ‘This is what we need.’ And he gave us a couple of really great pieces of legislation.” (In 2018, Gov. Chris Sununu signed Senate Bill 564, which provides a 10-year tax exemption from the business profits tax and the business enterprise tax to for-profit companies that have 75 percent of their taxable activity in the ARMI project. It also included a student loan repayment program for workers who stay on the project for five years.)

New Hampshire is also a strong geographic fit for the biofabrication hub. It’s right in the middle, Kamen says, of critical resources.

“Draw an X right from the northwest of here to the southeast,” he says. At the northwest point you have Dartmouth-Hitchcock Medical Center and Dartmouth College, and at the southeast point there’s Boston with Beth Israel, Mass General, Deaconess, Dana Farber, Children’s Hospital, MIT and Harvard.

On the other leg of the X is the University of New Hampshire at one point and Worcester Polytechnic Institute with its engineering and med schools at the other.

“We’re right at the center of a very rich area for engineering and medicine,” he says. “So why not use this as the hub of this new industry? It doesn’t require a lot of land. It doesn’t require a lot of energy. We’re not going to be like steel or automotive. We’re not going to be like semiconductors. What a perfect industry for this physical environment, this intellectual environment, for this geographic environment.”

At the center of that X, ARMI will be working with companies that are in early clinical phase manufacturing. Those companies would be welcomed into the 540 Commercial Street operation, where they would be teamed with ARMI staff and together develop the fledgling technology, whether it’s skin, bone, muscle or organ, into a scalable manufacturing process, including automations and quality control systems, standards and compliance.

Once that’s done and the company has what it needs to launch its own manufacturing operation, it would move out of 540 Commercial Street and into its own location, ideally in the Millyard or elsewhere in the Manchester hub. As more and more of these companies grow into commercial operations, the critical mass Kamen envisions would be achieved.

Presuming the critical mass builds in Manchester, Kamen is optimistic about how soon regenerative medicine products will be changing lives, especially given the success of the first few years of ARMI’s efforts.

“I think within 10 years of the day we started, there will be products that are at or have gone through the FDA that are having meaningful positive impact on people’s healthcare,” says Kamen. “Because that regenerative organ or tissue manufacturing has now created this solution to a real problem.”

NH is a strong geographic fit for the biofabrication hub, with access to critical resources.