NUI Galway Regenerative Medicine Institute (REMEDI) has launched a new €6m research project AUTOSTEM to develop pioneering manufacturing systems for stem cell therapy. Funded by the Horizon 2020 programme, AUTOSTEM will go a long way towards meeting the demand for these new treatments, by transforming the way stem cells are manufactured.
AUTOSTEM will develop a robotic cell production factory, the StromalCellFactory, which will minimise manual operation while producing large batches of cell product in a closed, sterile environment. The process involved extraction of adult stem cells from tissues such as bone marrow or fat followed by efficient purification and culture expansion in large-capacity bioreactors, finally packaging the product in a format ready for delivery to the patient.
The research project will be led by Dr Mary Murphy, senior lecturer in Regenerative Medicine and principal investigator at REMEDI at NUI Galway. REMEDI is a European leader in therapeutic stem cell research with investigators leading major EU-funded programmes that develop and test treatments for osteoarthritis, diabetic kidney disease, diabetic wound repair and corneal transplantation.
Dr Murphy comments: “This is an exciting interdisciplinary project that will take us beyond the state-of-the-art in stem cell manufacturing. The outcome will be a highly automated and efficient production technology that will allow patients worldwide to benefit from efforts to develop stem cell therapies.”
Other essential contributions will come from:
- NUI Galway’s Centre for Cell Manufacturing Ireland (CCMI) - the only licensed stromal cell manufacturing facility in Ireland, which will verify regulatory compliance and patient-readiness.
- Orbsen Therapeutics, a NUI Galway spin-out company that brings novel stem cell isolation procedures.
- The Fraunhofer Institute for Production Technology in Aachen, Germany, which provides robotic and control system expertise.
- The University of Aston, UK and the German company Zellwerk, who contribute optimal bioreactor technology for cell culturing within the ‘StromalCellfactory’.
- Crospon, another Galway SME, who will develop novel devices for sterile marrow harvesting and cell delivery to patients.
- The Tyndall Institute at UCC, who will develop a mobile sensor, building on existing ‘SmartPill’ sensor systems that will patrol the cell culture surface to enable remote real time process monitoring.
- The UK-based Cell Therapy Catapult research organisation, which will monitor cost-effectiveness and regulatory compliance.
Professor Frank Barry, REMEDI’s Scientific Director and technology leader on the research project said: “This project will be game-changing and will lead to remarkable new efficiencies in manufacturing, making the entire process more industrially relevant and cost-effective.”
REMEDI’s vision is to develop a new and realizable paradigm for medicine in the future utilizing minimally invasive therapeutic approaches to promote organ and tissue repair and regeneration thus avoiding the need for replacement. To achieve this, the REMEDI translational research programme has a mission to conduct basic research in fundamental stem cell biology and to translate and commercialise research outputs by developing regenerative medicine therapies for diseases such as; cardiovascular disease, diabetes mellitus and osteoarthritis.
About the Centre for Cell Manufacturing Ireland (CCMI), NUI Galway
A supporting platform for REMEDI Translational Research, CCMI is a dedicated facility to produce cellular therapeutic products. The Centre for Cell Manufacturing Ireland (CCMI) is the first facility on the island of Ireland to be licensed to manufacture cultured stem cells for human use e.g. Human Mesenchymal Stem Cells will be used as Advanced Therapy Medicinal Products (ATMPs) in the treatment of conditions such as critical limb ischemia (CLI) and osteoarthritis in the knee. The facility will translate as well as manufacture stem cell research from REMEDI's various programmes into cell based medicinal products for GMP investigational patient enrolled clinical trials.
About Orbsen Therapeutics
Orbsen Therapeutics Ltd is a privately held company and was originally founded in 2006 as a spin out from Ireland's Regenerative Medicine Institute (REMEDI) in NUI Galway. Since then, Orbsen has developed proprietary technologies (ORB1) that enables the isolation of pure and therapeutic stromal cells from human tissues. These therapeutic (ORB1+) cells can purified from a single donor, expanded and frozen to generate many doses of a high-margin, “off-the-shelf” therapeutic product for indications with unmet need. It is located at NUI Galway. Visit: www.orbsentherapeutics.com
For more information visit www.nuigalway.ie