Aug. 06, 2020
BioFabUSA, a Department of Defense-funded Manufacturing Innovation Institute within the Manufacturing USA network, has awarded the Georgia Institute of Technology and industry partner, Akron Biotech, a project titled, “Supply Chain and Process Modeling Algorithms, Methods, and Tools for Tissue Manufacturing and Distribution”. This project will address significant national supply chain issues related to distributing tissue engineered medical products (TEMPs) to U.S. patients in need.
The project aims to create the first simulation-based supply chain model for the rapidly evolving and future facing TEMPs industry, to minimize manufacturing and logistics costs and risks, incorporate Department of Defense (DOD) and other stakeholders’ perspectives into supply chain modeling, inform standards development, and support workforce development.
“Having a supply chain model will be instrumental in helping new and existing companies plan for the most efficient process flows, resource usage, and cost savings,” said Stephanie Robichaud, technical project manager with the Advanced Regenerative Manufacturing Institute. “Many startup companies do not realize some of the intricacies in managing their supply chain and many established companies realize the importance of it after experiencing inefficiencies. Having a model that these companies can use will help advance the field of tissue engineering as they plan for scale-up.”
According to Ben Wang, executive director of the Georgia Tech Manufacturing Institute (GTMI) and professor in the Stewart School of Industrial and Systems Engineering, “hundreds if not thousands of patients are waiting for tissues and organs in order to have a normal healthy life. Our project is a bold initiative to democratize distribution of replacement tissues and organs by streamlining national supply chains. This project will develop simulation-based tools to enhance the efficiency and resilience of the TEMPs supply chain, making these personalized medicines more affordable and more accessible.”
The growth of the TEMP industry is going to change the supply chain of medical tissues disruptively. To embrace this change, a system-level decision support tool is essential for adopting more cost-effective manufacturing processes and making better investment decisions. To ensure successful commercialization and adoption of this new supply chain decision support tool, the project team will engage multiple stakeholders including DOD, government, regulatory bodies, standards setting organizations, patients, industry, academia, policy experts, education and workforce development experts.
Georgia Tech project leads include Ben Wang, Ph.D., Chelsea C. White III, Ph.D, and Kan Wang, Ph.D. Ben Wang is Gwaltney Chair in Manufacturing Systems, professor in the Stewart School of Industrial & Systems Engineering and School of Materials Science and Engineering at Georgia Tech. In addition, he serves as executive director of the Georgia Tech Manufacturing Institute (GTMI). Chelsea C. White III is the Schneider National Chair in Transportation and Logistics and professor in the H. Milton Stewart School of Industrial and Systems Engineering at Georgia Tech. Kan Wang is lead researcher of additive manufacturing in the Bio-Engineering Research Laboratory at GTMI.
Leading the project for Akron Biotech is Ezequiel Zylberberg, Ph.D, who is vice president of product development and planning. According to Ezequiel, “the future of regenerative medicine depends on more than our ability to address the scientific challenges of generating the next generation of advanced therapies. Advancing these novel treatments in a way that is scalable will require significant advances in manufacturing innovation. We are eager to collaborate with our colleagues at Georgia Tech, at BioFab USA, and throughout the regenerative medicine industry to confront the challenge of scalability and supply chain resilience through this modelling effort.”
About the Georgia Institute of Technology
The Georgia Institute of Technology, also known as Georgia Tech, is one of the nation’s leading research universities — a university that embraces change while continually Creating the Next. The next generation of leaders. The next breakthrough startup company. The next lifesaving medical treatment.
Georgia Tech provides a focused, technologically based education to more than 36,000 undergraduate and graduate students. The Institute has many nationally recognized programs, all top-ranked by peers and publications alike, and is ranked among the nation’s top five public universities by U.S. News & World Report. It offers degrees through the Colleges of Computing, Design, Engineering, Sciences, the Scheller College of Business, and the Ivan Allen College of Liberal Arts. As a leading technological university, Georgia Tech has more than 100 centers focused on interdisciplinary research that consistently contribute vital research and innovation to American government, industry, and business. https://www.gatech.edu/
About Akron Biotech
Akron is a leading materials manufacturer and services provider to the regenerative medicine industry, accelerating the development and commercialization of advanced therapies. Founded in 2006, Akron is an ISO 13485-certified company that operates in line with cGMPs and international standards, enabling advanced therapy developers to de-risk their supply chains and facilitate regulatory approval. The company's unique business model emphasizes knowledge, flexibility and unparalleled service—from development through to commercialization. For more information, please visit www.akronbiotech.com.
About BioFabUSA
BioFabUSA, is a DOD-funded Manufacturing USA Innovation Institute (MII) sustained by the Advanced Regenerative Manufacturing Institute (ARMI) is a non-profit organization located in Manchester, New Hampshire. ARMI's mission is to make practical the scalable, consistent, cost-effective manufacturing of tissue engineered medical products and tissue-related technologies, to benefit existing industries and grow new ones. https://www.armiusa.org/
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Jul. 28, 2020
Personal initiatives by a pediatrician and by researchers to make face shields for medical workers have transformed into an industry collaboration that by June had delivered 1.8 million shields to hospitals and other organizations around the country with plans to produce 2.5 million all total. A $2 million donation from Aflac Incorporated for personal protective equipment (PPE) financed the bulk of the shields.
To make it happen, a team of researchers and industry partners convened at the Global Center for Medical Innovation (GCMI), a Georgia Tech-affiliated nonprofit that guides new experimental medical solutions to market. The group combined the physician’s vision with the researchers’ original designs, adjusted them to pass FDA emergency guidelines, and then coordinated mass production and distribution.
A physician’s wisdom
The project grew wings in mid-March, after Dr. Joanna Newton became concerned that the nationwide shortage of PPE was leaving healthcare workers across the country vulnerable. Newton is a physician specializing in improving healthcare safety through technology at Children’s Healthcare of Atlanta, and she was already collaborating with Georgia Tech on other projects.
She grabbed the phone to leverage the connection.
“I called Sherry Farrugia to tell her about my idea to 3D-print PPE. We needed to quickly find a solution for the PPE shortage around the country, and I knew we had the right team here in Atlanta to help,” said Newton, a pediatric hematologist/oncologist at the Aflac Cancer and Blood Disorders Center of Children’s.
“The situation was urgent, and I knew who would have the right expertise to get this done,” said Farrugia, chief operating officer and strategy officer of Children’s Healthcare of Atlanta Pediatric Technology Center, which is part of Georgia Tech.
Farrugia had Newton present her idea at GCMI to researchers, advisors, and industry partners who immediately put together a team to address the need for face shields to protect healthcare workers from droplets containing the coronavirus. She also discussed the need with Devesh Ranjan, associate chair of the George W. Woodruff School of Mechanical Engineering, who suggested connecting the effort to a parallel initiative in that school.
Bringing in engineers
At the same time, along with Ranjan, Sam Graham, chair of the George W. Woodruff School of Mechanical Engineering, and Susan Margulies, chair of the Wallace H. Coulter Department of Biomedical Engineering, were coordinating efforts across campus to develop various medical devices in response to the pandemic. Graham, Margulies, and Ranjan quickly connected GCMI with Christopher Saldana and Saad Bhamla, faculty members in Georgia Tech’s College of Engineering, who were leading an simultaneous effort to address the face shield problem with their students using rapid fabrication techniques like 3-D printing, laser cutting, and waterjet cutting.
“The Georgia Tech mechanical engineering team used rapid fabrication equipment and quickly produced multiple face shield designs that could be manufactured in high volumes for the rapid response environment that Covid-19 required,” Saldana said.
Making a few thousand shields in a lab had likely already saved lives, but the Georgia Tech researchers and GCMI put their designs on the internet, where they have been downloaded thousands of times by organizations manufacturing them around the world. And the manufacturing partners they engaged have been turning out hundreds of thousands of shields to save many more lives.
“You may need 45 minutes for a headband with a 3D printer, but manufacturers turn out six of them every 19 seconds. Then making a million face shields becomes a real possibility,” said Mike Fisher, who leads product development at GCMI.
GCMI opened a GoFundMe page, which brought in $20,000, and then engaged their first manufacturing partner, Delta Air Lines.
A manufacturing explosion
“Delta converted one of their groups from manufacturing airplane interiors to doing the face shields. They started off by manufacturing 6,000 shields, and that got the momentum going,” Leiter said. “Two thousand shields went to Mount Sinai Hospital in New York; 2,000 went to Piedmont Healthcare in Atlanta; and 2,000 went to Children’s Healthcare of Atlanta.”
Things began to snowball.
Graham engaged Siemens Industries to fulfill a face shield order from the Georgia Emergency Management Agency (GEMA) for distribution in Georgia. Partners from ExxonMobil began looking for more potential manufacturers. And Aflac contacted Children’s looking for worthy Covid-19 related efforts to support.
“We asked for a donation of $500,000 for manufacturers to retool their operations. Aflac made a gift of $2 million to GCMI to promote the production of PPE,” Farrugia said. “We were able to buy tooling for an automotive plastics manufacturer called Quality Model in South Carolina, and they have made over 750,000 face shields so far.”
GCMI won a bid from the Federal Emergency Management Agency (FEMA) for 1,141,600 face shields, which are being made by Quality Model, where ExxonMobil helped rearrange production lines for shields.
Siemens made an additional 100,000 shields from Aflac’s gift, which is also being used to purchase existing PPE to donate to healthcare workers. Kia Motors quickly produced an initial 15,000 shields, which the company financed itself.
“Kia got the open source design from the Georgia Tech website and ran with it on their own,” Saldana said.
These partners are delivering the following number of shields: Quality Model, 1,251,600; Kia Motors, 300,000; Siemens Industries, 205,000; Delta Air Lines, 106,100; Georgia Tech, 20,000; and EIS, 15,000. And more are still to come.
The shields went across the country, from hospitals in New York City to Prisma Health in South Carolina, to nursing homes in the Pensacola area, and to rural Louisiana and Mississippi, Leiter said.
Thanks in large part to Aflac’s gift, GCMI and Farrugia are coordinating with partners, including Georgia Tech engineers, to produce N95 masks, hospital gowns, and hand sanitizer, all redesigned for the Covid-19 age.
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Jul. 01, 2020
Apr. 22, 2020
Gaps in the supply of coronavirus tests are propelling initiatives to fill them across the country. At the Georgia Institute of Technology, bioscience researchers are burning the midnight oil to produce key components for tests in the state of Georgia.
The goal is to supply a broad initiative by the governor’s office involving multiple universities and partners to rapidly produce and administer more tests. At least 35 volunteers at Georgia Tech, while adhering to social distancing, are reorienting labs normally used for scientific discovery to do larger-scale production of biochemical components.
“We are inventing new ways of doing things like an electronic buddy system so people can be alone – but not alone – while they work in the lab. The technical part is actually the easiest. The logistics of testing, data security, and regulatory considerations – those things are more challenging,” said Loren Williams, a professor in Georgia Tech’s School of Chemistry and Biochemistry.
Williams and the researchers are supporting Georgia Governor Brian Kemp’s COVID-19 State Lab Surge Capacity Task Force, which is a project managed through the Georgia Tech Research Institute (GTRI). GTRI is also leading the coordination and integration of data management across the lab surge effort.
“We are providing technical and project management of the effort which is focused on increasing the state’s ability to expand testing beyond current limitations,” said Mike Shannon, GTRI’s lead in the project and a principal research engineer at GTRI.
Exoplanets and coronavirus
The science behind coronavirus testing is complementary to the researchers’ usual work. That includes understanding proteins associated with glaucoma, figuring out how RNA and DNA evolved in the first place, or whether ribosomes – lumps of RNA and protein key to translating genetic code into life – may exist on exoplanets.
Williams’ research team studies the last topic, and some of their work is related to the core of coronavirus testing, a chemical reaction that amplifies the virus’ genetic fingerprint. It is called a reverse transcription polymerase chain reaction (RT-PCR), and it transcribes trace amounts of coronavirus’ RNA code into ample amounts of corresponding DNA in the lab for easy analysis.
“His lab members are very familiar with RT-PCR, and when the lack of tests became apparent, they swung into action. The group grew from there, based on the technical needs for the project,” said Raquel Lieberman, another leading scientist in the effort and also a professor in Georgia Tech’s School of Chemistry and Biochemistry.
“Every day, very talented, hardworking people with perfect skill sets come out of the woodwork and ask to help,” Williams said.
The group has teams that engineer the production of enzymes or other chemicals needed for RT-PCR to work: Two central enzymes are reverse transcriptase, which converts RNA to DNA and Taq polymerase, which rapidly replicates DNA. Another important component is ribonuclease inhibitor, which slows coronavirus RNA decay.
Global COVID allies
Other researchers develop processes for mass production or implementation of COVID-19 safety procedures; the list goes on. Some colleagues telework; others work in labs but spaced far from each other while they wear masks.
“The group is planning to produce enough enzyme components for hundreds of tests per day,” said Vinayah Agarwal, an assistant professor in Georgia Tech’s School of Chemistry and Biochemistry and School of Biological Sciences. “Using these components, we will also build cheaper and more robust testing kits going forward.”
Instructions already exist for some of the ingredients for the test, but they are not readily available because the rights to them are exclusive.
“Intellectual property and other proprietary issues hinder our effort,” Lieberman said. “But we have received help from scientists all over the world to piece together protocols on how to make what we need.”
The state wants to increase current testing capacities by 3,000 more tests per day. The task force also includes teams from Augusta University Health System, Georgia State University, Emory University, University of Georgia, and the Georgia Public Health Laboratory. The task force lead is Captain Kevin Caspary who is with the Georgia National Guard.
Raw footage and images as press handouts for journalists. (No commercial or personal use):
https://www.dropbox.com/sh/f2wc2i74lz1lffl/AADLJ8dQnZMr4uEDxAiIMusoa?dl=0
Also read this: Interactive COVID-19 tool shows the importance of staying at home
External News Coverage:
NPR - Sun Rays, Disinfectants And False Hopes: Misinformation Litters The Road To Reopening
News-Medical.Net - Georgia Tech researchers create key components for COVID-19 tests
Georgia Tech News Center- A New Normal: Researchers Across Georgia Tech Rally to Fight COVID-19
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Writer & Media Representative: Ben Brumfield (404-272-2780), email: ben.brumfield@comm.gatech.edu
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