NUI Galway’s Regenerative Medicine Institute (REMEDI) has launched a new €6 million research project AUTOSTEM to develop pioneering manufacturing systems for stem cell therapy. Funded by the EU 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.
Stem cells offer exciting prospects of new therapies for a range of diseases, including cancers, diabetic complications and arthritis. However, current manufacturing protocols are relatively inefficient and require highly-skilled teams of technicians operating in a clean-room environment. As clinical trials progress, efficient and high throughput manufacturing remains a major challenge with the risk that supply will not meet demand.
AUTOSTEM will develop a robotic cell production factory, the StromalCellFactory, which will minimise manual operations while producing large batches of cell product in a closed, sterile environment. The process involves 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.
Tyndall National Institute 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 detection device will incorporate cutting edge semiconductor processing technology which will be used to fabricate disposable, highly sensitive sensor chips. Dr Karen Twomey team lead at Tyndall said, “there are a number of challenges in this project such as reliable measurement of the parameters of interest over prolonged periods of time. We will work closely with the Autostem consortium to understand the environment in which the device will need to operate and develop a robust, sensitive, continuous monitoring tool for cell and media analysis.”
All contributions on this project 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.
Tyndall National Institute 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.”
The project is funded by the European Union Horizon 2020 EU Framework Programme for Research and Innovation.