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Keywords: Regenerative Medicine, ARMI, BioFabUSA, Automation, Tissue Automation, ACL Automation, Organ Automation, ARC Advisory Group.
Overview
Having toured and worked in numerous pharmaceutical and biotechnology manufacturing plants (and industries) around the world, one of the most interesting and evolutionary tours I have ever encountered was a recent visit to the Advanced Regenerative Manufacturing Institute (ARMI) located in Manchester, NH. The production facility is completely automated with Rockwell Automation technology and is not only one of the most innovative operations in the global biotechnology industry but is likely to make one of the biggest differences to the future of medicine in this century.
ARMI and BioFabUSA are combining innovative technologies and bio-technology to produce human tissues including skin and ACL and organs (future). BioFabUSA, a program of ARMI, is a public-private partnership with more than 170 members, including companies, academic institutions and not-for profit organizations. BioFabUSA is one of 16 Manufacturing USA institutes that are part of a federal initiative that started under the Obama administration. It is run by the Advanced Regenerative Manufacturing Institute (ARMI), a nonprofit organization with member involvement. BioFabUSA combines cell and tissue cultures with innovations in biofabrication, automation, robotics and analytic technologies to develop new processes and scalable manufacturing that comply with FDA regulations.
About ARMI/BioFabUSA
Dean Kamen, executive director of ARMI, and founder of FIRST Robotics and inventor of the Segway human transporter, the first automatic, wearable insulin pump, portable dialysis machines, a water purifier, an all-terrain electric wheelchair and the DEKA-Luke prosthetic arm is responsible for ARMI’s success. Dean Kamen, executive director of ARMI, told us while touring the BioFabUSA facility that he had told President Barack Obama years ago that the difference between scientific research and industry is huge. “We don’t have an industry foundation that is going to take the science out of the labs and bring it to industry.” He told us that the reason he wanted to work with ARMI is that he felt that this was needed for this innovation.
BioFabUSA is staffed by 67 employees along with other employees from over 200 member companies. ARMI has grown to well over 200 members in just a few years. Dean Kamen used his professional contacts, standards, automation systems, and other infrastructure to get ARMI up and running.
ARMI Considers Automation
ARMI began with an $80 million grant from the U.S. Department of Defense through a grant to BioFabUSA as well as from member companies, that include Rockwell Automation. Kamen’s goal was to not only enable the ability to grow human tissue and eventually organs, but to automate the process similar to a semi-conductor process and to make it accessible enough to provide equipment that could produce tissue in a hospital, a provider’s office or other clinical setting.
Mr. Kamen began by working with the Department of Defense and mechanical engineers, automation engineers, control engineers, leading technology companies, etc. He told the ARMI board, “We do not have a single MD in my company. We do not know about synthetic biology. We only know about the engineering side of the things we do.” Mr. Kamen told ARC that he also recruited technology leaders to help with this industry transformation. He called John Abele, the co-founder and director of Boston Scientific and Martine Rothbaltt, United Therapeutics CEO and founder of Sirius Satellite Radio. He told us that he knew Blake Moret, CEO of Rockwell Automation through FIRST Robotics. He involved Blake in ARMI’s earliest days, realizing the potential role automation could play in bridging the gap between laboratory science, automation and a commercially viable product. Along with Dr. Jim Weinstein, Senior Vice President for Microsoft, these leaders formed the first BioFabUSA board of directors.
Automating Skin and Organ Production
Rockwell Automation was one of the first companies to join ARMI and BioFabUSA. Most of the first year they spent a lot of time teaching members about automation. Then these employees created the automated tissue manufacturing facility which is the first automated tissue line in the world. Rockwell automation supplies the automation technology and knowledge required to run the tissue foundry and is continuing to work with ARMI and BioFabUSA for other units for other organs, but the biotechnology needs to catch up with the automation technology for biofabrication.
Today ARMI is manufacturing human tissue and ACL. The concept is innovative where they take a blood sample or skin sample and use the person’s individual DNA to manufacture personalized tissue that can be used for skin grafts for people who were in a fire for or in the case of ACL can be used for people who play sports and need new ACL that is uniquely theirs. Their bodies will not reject the human tissue or the ACL because it is based on their unique DNA.
Future of Organ Production
Along with human tissue and ACL, the manufacturing of other organs will be part of the near future. Mr. Tom Bollenbach, Chief Technology Officer, BioFabUSA, told us that, “compared with the complexities of regenerating three dimensional organs, generating cells or tissue is relatively easy. Kidneys, livers, pancreas, hearts or lungs, all of which are in the works by ARMI member companies, are more complex because they are 3D.” There is a lot involved with some organs. He thought that the next organ might be either a human lung or heart, then pancreas or liver, and kidneys would likely be the hardest, but all are within reach of being automated. He said Kidneys are one of the more complex organs because there are a lot of challenges like how you transport nutrients and oxygen for example to interior cells and how to remove waste products. As Mr. Kamen told ARC, “Wouldn’t it be great to get a new heart or liver that your body will not reject, that can be produced automatically right at the clinical site. And the patient does not have to wait for someone to die to get the organ either.”
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