Overview
The Advanced Regenerative Manufacturing Institute, better known as ARMI, is a non-profit consortium of leading life science companies, academic institutions, non-profit organizations, and key thought leaders working to realize the vast, yet unrealized, promise of tissue engineering and regenerative medicine (TERM).
Lab Owl, an Automated Control Concepts (ACC) company, became a member of the ARMI consortium in 2019. Since that time, the Lab Owl product has been integrated into ARMI’s Tissue Foundry manufacturing process, and the Lab Owl team has made important contributions to several working groups tasked with solving some of the challenges facing tissue engineering and regenerative medicine manufacturing. These working groups include establishing ARMI’s Workforce Characteristics Charter; the Tissue Maturation and Bioreactor Charter; and the Cell Culture and Harvest Charter.
Lab Owl’s collaboration with ARMI and its partners is helping to move the needle toward a fully automated, closed tissue manufacturing process that will reduce costs, increase safety and eventually bring more regenerative medicine products to the market.
“Our collaboration with ARMI, and specifically with the Tissue Foundry lab, has been incredibly rewarding. Those of us involved in cell culture and bioprocessing understand that in order to get more personalized, regenerative medicines to patients, challenges surrounding scalability, automation, and run consistency have to be solved and we’re proud to be part of ARMI’s mission to accomplish this,” stated Michael Blechman, the CEO of ACC and Lab Owl.
Tissue Engineering Challenges
The challenges for tissue engineering and personalized medicine are myriad and are encapsulated by ARMI’s use of the acronym SMAC, which means scalable, modular, automated, and closed.
Each of these categories represents an existing bottleneck to tissue engineering and manufacturing. Founded in 2017 with the support of $80M in funding from the Department of
Defense (DoD), ARMI/BioFabUSA is working to eliminate tissue commercialization bottlenecks by making practical the scalable, consistent, and cost-effective manufacturing of engineered tissues and tissue-related technologies. BioFabUSA’s work includes innovations across five focus areas: (1) Cell Selection, Culture, and Scale-up, (2) Biomaterial Selection and Scale-up; (3) Tissue Process Automation and Monitoring; (4) Tissue Maturing Technologies and (5) Tissue Preservation and Transport.
Regenerative medicine therapeutics are notoriously difficult to scale from smaller form factors into the larger bioreactors necessary to produce viable therapeutics. What’s more, traditional bioreactor automated control and information systems lack the modularity and flexibility to accommodate the highly specific needs of regenerative medicine manufacturing processes. A dearth of automated processes and closed-loop data capture systems lead to more labor-intensive, human error-prone, and more expensive cell culture processes that create greater risk for run failure and producing batches that won’t pass muster with regulatory agencies.
The Tissue Foundry needed to find a bioreactor control system that could be easily integrated into its existing Supervisory Control and Data Acquisition (SCADA) System based on Rockwell Automation infrastructure while providing the SMAC capabilities it needed to further its many ongoing tissue engineering projects.
Lab Owl’s Bioreactor Automation and Control System Enhances the Tissue Foundry’s SMAC Capabilities
Tissue and bone manufacturing has been done on an artisanal, small scale for decades; the goal of the Tissue Foundry is to demonstrate the ability to scale tissue and bone manufacturing to commercial levels through viable automated manufacturing and control processes.
As part of this effort, ARMI integrated two Lab Owl bioreactors into its Tissue Foundry’s SCADA System. During the initial integration build-out, each of the Lab Owl bioreactors was managing five ARMI tissue bioreactors.
Lab Owl enhanced the Tissue Foundry’s SCADA System by adding remote access, automated bioreactor control, and information capabilities that the Tissue Foundry needed to achieve greater tissue engineering efficiency and productivity. Across a wide range of measurables, Lab Owl is helping Tissue Foundry research scientists become more efficient, enabling them to perform more reliable, automated cell culture runs; make faster go, no-go decisions, and quickly adapt to changing demands and requirements.
“We met Kevin and Michael at the Rockwell Automation Fair about two years ago. They presented Lab Owl and we thought it was pretty cool and it had Rockwell internal components, which was intriguing to us,” stated Tom Bollenbach, ARMI’s Chief Technology Officer.
“The Lab Owl System uses a Rockwell PLC and because our SCADA system is a Rockwell system the integration was seamless. However, the standard Lab Owl software wasn’t sufficient for us and we needed to extend the capabilities so we could talk to the supervisory control system,” he added.
Stu Jacobson, the principal engineer for the first iteration of the Tissue Foundry stated, “Integration into our PLC system, along with the complex automation protocols desired, required an extension of the Lab Owl software capabilities. We worked closely with Lab Owl through several revisions of the Lab Owl software to get it configured with the capabilities required. Lab Owl was very responsive to our needs throughout this process.”
“Lab Owl and our team worked very closely together to make the revisions needed to make everything compatible,” Bollenbach added. “Lab Owl was always super responsive, very engaged and always checking in with us. They were always willing to go the extra mile. Folks look at a technology that can create ligaments and are astonished, but in reality, the actual triumph was getting all of the individual modules to speak to each other, hand off to each other, and report data out into a common space. And that’s what Lab Owl did really well for us.”
“Lab Owl is really willing to test out new capabilities, like new sensors that will have to get integrated into our system and that is controlled by the Lab Owl. The Lab Owl team is very open and willing to work collaboratively, which has been great,” stated Bollenbach.
Outcomes
Much of the work at the Tissue Foundry is ongoing, and in some cases confidential, but Lab Owl has made significant contributions to its mission and that of the ARMI consortium.
The Tissue Foundry has presented some of its results at recent ARMI summits, including recent news that it was able to integrate the STEL bone-ligament-bone process for Anterior Cruciate Ligament (ACL) replacement into the Tissue Foundry and successfully ran all parts of the system, including Lab Owl media conditioning.
“This is a once-in-a-lifetime opportunity to help shape the future of cell culture and bioprocessing,” stated Kevin Hannigan, President of ACC and Lab Owl. “Finding ways to eliminate inefficiencies and bottlenecks in the process will not only benefit researchers and drug developers, but it will also facilitate the delivery of more therapeutics to patients at scale and with the lower costs needed to make tissue engineering commercially viable.”
