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.
A chance meeting at the International Conference on Biofabrication and a presentation by Dr. Richard McFarland, ARMI Chief Regulatory Officer, led one of the nation’s top research institutions to join the ARMI ecosystem
Thanks to engagement with ARMI from its local sales team, NanoString is now part of the BioFabUSA ecosystem. In December of 2020, ARMI began partnering with with the company, providing feedback on the content of a new stem cell characterization panel that was under development. The panel launched in April of 2021, and NanoString joined the ARMI community to partner in further advancing the field of regenerative medicine.
Headquartered in Edison, New Jersey, MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. The company provides safe, high-quality tissue grafts from donated human tissues that are used in a growing array of clinical fields, including orthopedics, plastic and reconstructive surgery, wound care, and regenerative medicine.
ARMI | BioFabUSA is currently working with a BioFabUSA member, the Standards Coordinating Body (SCB), on a huge undertaking for the entire tissue-engineering and regenerative medicine industry - evaluating and updating terminology relevant to the Tissue-Engineered Medical Product community. As many of you may have experienced, a major challenge with building a robust tissue engineering ecosystem is ensuring clear communication pathways across interdisciplinary teams.
Ronawk is a biotech spinout company from the University of Kansas Medical Center, and was founded by Dr. A.J. Mellott and Heather Decker using the stem cell expansion technology that was invented by Dr. Mellott. The stem cell expansion technology that Ronawk refers to as “Tissue Blocks” (T-Blocks) are modular interlocking scaffolds that permit primary mesenchymal stem cells to rapidly grow in 3D while maintaining the MSC phenotype
Apsis Healthcare Systems founded in 2019 and based at Gaithersburg, MD is a Process Analytical Technology organization that brings together a suite of technology aimed at advancing the state of manufacturing in the biologics, cell therapy and regenerative medicine industries.
CollPlant’s revolutionary plant-based technology is the only commercially viable technology for mass production of Type I recombinant human (rhCollagen), which is identical to the collagen produced by the human body. Leveraging on the unique properties of rhCollagen and biomaterial know-how, CollPlant is developing a pipeline of products aimed at 3D bioprinting of tissues and organs and medical aesthetics.
Through exploratory and practical research, UMass Lowell’s faculty translates discoveries into powerful solutions with their world-class facilities and research infrastructure. Working across disciplines, faculty members collaborate with industry, startups and communities to innovate and build solutions that make a difference in peoples’ lives.
Amid the coronavirus disease (COVID-19) crisis, BioFabConsulting would like to highlight the importance of adhering to the regulations to maintain patient safety.
When John Cadwell recognized the need for hollow fiber bioreactor solutions for laboratory cell culture requirements he capitalized on his idea. In March 2000, Cadwell founded FiberCell Systems, which over the last two decades has supplied hollow fiber bioreactors to the biomedical research and development community.
BioFabUSA helps members stay up-to-date on regulatory decisions which may affect medical product availability and regulation. In 2018, the FDA indicated their intent to reclassify hyaluronic acid (HA) intra-articular products indicated for use in patients with osteoarthritis (OA) of the knee from a device to a drug.
O2M, a start-up company located in Chicago, IL, offers oxygen imaging instruments and services for regenerative medicine and preclinical cancer studies.
TheWell Bioscience Inc., a New Jersey biotech company focused on 3D cell culture, works to accelerate the process of drug discovery and personalized medicine.
Asymmetrex, headquartered in Boston, Massachusetts has the goal of moving the fields of stem cell science and stem cell medicine into a new quantitative era.
Biocut collaborates with leading bioscience industry companies to assess current market needs and requirements, then develop products that deliver new technology and unparalleled levels of performance which improve productivity which in turn shortens time to market.
BioFabUSA is committed to assisting its members to ruminate on all potential regulatory pathways and market strategies for their product, and as such would like to highlight unique benefits presented to sponsors who utilize drug master files (DMFs).
The RACER Blueprint is comprised of Five key factors, in addition to manufacturing, that are essential to a good idea making it from an academic achievement to part of a clinician’s armamentarium.
The RACER Blueprint is comprised of Five key factors, in addition to manufacturing, that are essential to a good idea making it from an academic achievement to part of a clinician’s armamentarium.
SSR (Sustainable Swine Resources) is committed to creating sustainable partnerships with life science companies and researchers to provide high-quality, reliable porcine materials for use in improving, prolonging and saving lives.
The RACER Blueprint is comprised of Five key factors, in addition to manufacturing, that are essential to a good idea making it from an academic achievement to part of a clinician’s armamentarium.
The RACER Blueprint is comprised of Five key factors, in addition to manufacturing, that are essential to a good idea making it from an academic achievement to part of a clinician’s armamentarium.
The RACER Blueprint is comprised of Five key factors, in addition to manufacturing, that are essential to a good idea making it from an academic achievement to part of a clinician’s armamenterium.
NovaSterilis, located in Ithaca, NY, is a company focused on supporting regenerative medicine manufacturers by processing (e.g., cleaning, sterilizing, impregnating, and improving) materials with supercritical carbon dioxide.
Over the last 10 years, Cal Poly has provided well-trained graduates for the Regenerative Medicine Industry through a Regenerative Medicine Interdisciplinary Program that integrates students and faculty from Biomedical Engineering, Biological Sciences, and Animal Science.
Five key factors, in addition to manufacturing, are essential to a good idea making it from an academic achievement to part of a clinician’s armamenterium. These factors are not in the engineering, scientific, or medical curricula in sufficient depth for one to master them without additional training or experience. They are, nevertheless, at least as important as the scientific and engineering foundations of a TEMP (or other advanced therapy) with respect to full commercialization.
Scientists have taken a major step closer to being able to 3D bioprint functional organs by devising a method of rebuilding components of the human heart. FluidForm, a new ARMI member, is making this technology available for research and commercial applications, with the ultimate goal to revolutionize regenerative medicine and impact millions of Americans every year.
Progenesis Technologies LLC, a Huntington, WV bio-engineering company, says producing customized molecular scaffolds from alginate products has a “fundamental advantage over seaweed derived alginates in cost efficiencies and customization for various applications,” according to Gardiner F.H. Smith, Executive Chairman.
CAST, a nonprofit organization headquartered in Wakefield, MA, believes learning should have no limits. Founded in 1984, by education researchers, CAST created the Universal Design for Learning (UDL) framework, a set of principles based on learning sciences including neuropsychology, human development, and education research.
My name is Andrew Attar and I am the Data Analysis intern at ARMI. I recently graduated from Tufts University where I was a pre-medical student in addition to studying English and Economics.
Xylyx Bio spun out of Columbia University’s renowned Laboratory for Stem Cell and Tissue Engineering in 2016 to commercialize matrix bioactives for tissue regeneration and complete cell health.
ARMI's BioFabUSA program is designed to attract and develop an ecosystem of both large and small industrial/commercial institutions. Given the nascent stage of the regenerative manufacturing industry, this includes Tissue-Engineering and Regenerative Medicine (TERM) startup companies as well as larger firms that see this as an attractive adjacent market opportunity. Also included in this ecosystem are educational, medical and mission driven non-profit institutions whose areas of research, areas of practice or philanthropic mission include, or could benefit from, TERM or TERM related therapies or technologies. This includes organizations whose mission align with the prospect of developing TERM therapies to help cure certain diseases (e.g., diabetes, renal failure and limb loss) or advancing the tissue manufacturing industry (e.g., engineering/scientific societies and standards development organizations).
A chance meeting at the International Conference on Biofabrication and a presentation by Dr. Richard McFarland, ARMI Chief Regulatory Officer, led one of the nation’s top research institutions to join the ARMI ecosystem
Thanks to engagement with ARMI from its local sales team, NanoString is now part of the BioFabUSA ecosystem. In December of 2020, ARMI began partnering with with the company, providing feedback on the content of a new stem cell characterization panel that was under development. The panel launched in April of 2021, and NanoString joined the ARMI community to partner in further advancing the field of regenerative medicine.
Headquartered in Edison, New Jersey, MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. The company provides safe, high-quality tissue grafts from donated human tissues that are used in a growing array of clinical fields, including orthopedics, plastic and reconstructive surgery, wound care, and regenerative medicine.
Ronawk is a biotech spinout company from the University of Kansas Medical Center, and was founded by Dr. A.J. Mellott and Heather Decker using the stem cell expansion technology that was invented by Dr. Mellott. The stem cell expansion technology that Ronawk refers to as “Tissue Blocks” (T-Blocks) are modular interlocking scaffolds that permit primary mesenchymal stem cells to rapidly grow in 3D while maintaining the MSC phenotype
Apsis Healthcare Systems founded in 2019 and based at Gaithersburg, MD is a Process Analytical Technology organization that brings together a suite of technology aimed at advancing the state of manufacturing in the biologics, cell therapy and regenerative medicine industries.
CollPlant’s revolutionary plant-based technology is the only commercially viable technology for mass production of Type I recombinant human (rhCollagen), which is identical to the collagen produced by the human body. Leveraging on the unique properties of rhCollagen and biomaterial know-how, CollPlant is developing a pipeline of products aimed at 3D bioprinting of tissues and organs and medical aesthetics.
Through exploratory and practical research, UMass Lowell’s faculty translates discoveries into powerful solutions with their world-class facilities and research infrastructure. Working across disciplines, faculty members collaborate with industry, startups and communities to innovate and build solutions that make a difference in peoples’ lives.
When John Cadwell recognized the need for hollow fiber bioreactor solutions for laboratory cell culture requirements he capitalized on his idea. In March 2000, Cadwell founded FiberCell Systems, which over the last two decades has supplied hollow fiber bioreactors to the biomedical research and development community.
O2M, a start-up company located in Chicago, IL, offers oxygen imaging instruments and services for regenerative medicine and preclinical cancer studies.
TheWell Bioscience Inc., a New Jersey biotech company focused on 3D cell culture, works to accelerate the process of drug discovery and personalized medicine.
Asymmetrex, headquartered in Boston, Massachusetts has the goal of moving the fields of stem cell science and stem cell medicine into a new quantitative era.
Biocut collaborates with leading bioscience industry companies to assess current market needs and requirements, then develop products that deliver new technology and unparalleled levels of performance which improve productivity which in turn shortens time to market.
SSR (Sustainable Swine Resources) is committed to creating sustainable partnerships with life science companies and researchers to provide high-quality, reliable porcine materials for use in improving, prolonging and saving lives.
NovaSterilis, located in Ithaca, NY, is a company focused on supporting regenerative medicine manufacturers by processing (e.g., cleaning, sterilizing, impregnating, and improving) materials with supercritical carbon dioxide.
Over the last 10 years, Cal Poly has provided well-trained graduates for the Regenerative Medicine Industry through a Regenerative Medicine Interdisciplinary Program that integrates students and faculty from Biomedical Engineering, Biological Sciences, and Animal Science.
Scientists have taken a major step closer to being able to 3D bioprint functional organs by devising a method of rebuilding components of the human heart. FluidForm, a new ARMI member, is making this technology available for research and commercial applications, with the ultimate goal to revolutionize regenerative medicine and impact millions of Americans every year.
Progenesis Technologies LLC, a Huntington, WV bio-engineering company, says producing customized molecular scaffolds from alginate products has a “fundamental advantage over seaweed derived alginates in cost efficiencies and customization for various applications,” according to Gardiner F.H. Smith, Executive Chairman.
CAST, a nonprofit organization headquartered in Wakefield, MA, believes learning should have no limits. Founded in 1984, by education researchers, CAST created the Universal Design for Learning (UDL) framework, a set of principles based on learning sciences including neuropsychology, human development, and education research.
Xylyx Bio spun out of Columbia University’s renowned Laboratory for Stem Cell and Tissue Engineering in 2016 to commercialize matrix bioactives for tissue regeneration and complete cell health.
Axogen is the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair.
Vericel develops, manufactures, and markets autologous cell-based therapies for patients with serious diseases and conditions in sport medicine and severe burn cases and is a leader in the development of autologous cell therapies to repair or restore damaged tissues or organs.
Pluristyx was established in 2018 with the goal of solving challenges associated with cell manufacturing by manufacturing GMP grade pluripotent stem cells at large scale for use as a universal starting material for the further manufacturing of therapeutic regenerative medicine products.
RoosterBio was founded in 2013 to specifically address the industry-wide bottleneck that is the scarcity of high quality and scalable cellular starting materials for product development and clinical manufacturing, is a pioneer in Regenerative Medicine (RM) manufacturing, with a focus on human mesenchymal stem/stromal cells (hMSC) raw materials, bioprocess design, and production technologies.
Sudhin Biopharma is an early-stage Biopharma technology development company located in Superior, CO, founded in 2014 by Prof. Dhinakar Kompala, after taking early retirement from his faculty position in the department of Chemical and Biological Engineering at the University of Colorado, Boulder.
Trailhead Biosystems, headquartered in Cleveland, Ohio, merges developmental biology and cell therapeutics with cutting edge hardware, computerized experimental design, and analysis to perform process-specific parameter optimization in the development of cell therapies.
AlloSource is a 501(c)3, not-for-profit organization, headquartered in Centennial, Colorado with approximately 500 employees dedicated to advancing the science and use of transplantable allogeneic cells and tissue through pioneering research in regenerative therapies.
ArunA Bio, located in Athens, Georgia, with nearly 20 employees, was founded in 2005 as a developer and manufacturer of human neural-specific cell lines. The company has since transformed into a drug development company with a duel focus platform technology.
BCS was founded in 2011 and is headquartered in Rockland, Massachusetts. The company designs and implements custom technology roadmaps for Life Science & Manufacturing companies delivering end-to-end IT and communications solutions that are cost-effective and match specific operational needs.
For over 40 years in the US and 80 years globally, Festo has been a positive force for manufacturers with a passion for automation productivity — intelligent automation solutions that transform the way people work — and the way companies compete.
GSGWM offers a wide variety of outcomes-based STEM programs to over 10,000 girls across Vermont and New Hampshire every year and it is one of just a few of Girl Scout councils in the US to see membership growth for three consecutive years.
