NUI Galway’s Regenerative Medicine Institute has launched a new €7.45 million project to develop ground-breaking and innovative scientific and engineering platforms for the production of advanced cellular therapeutics for use in the treatment of osteoarthritis and other major diseases. 

Funded by the EU Horizon 2020 programme the AutoCRAT project will address the critical need to develop industrially relevant, cost effective and fully automated manufacturing systems for this new area of medical treatment. Based on a strong interdisciplinary and collaborative effort, it will generate a deeper understanding of the science of stem cells and their therapeutic use as well as harnessing world-class expertise in advanced engineering and robotic systems. The project will also meet the need for development of an effective treatment for osteoarthritis and the demand for other cell-based treatments by transforming the way stem cells and their secreted therapeutic factors (mainly a novel type of biological nanoparticles, the so called extracellular vesicles (EVs)), are manufactured.

Cellular therapies are being tested for a wide range of conditions including degenerative diseases, immune and inflammatory disorders and cancer. These revolutionary therapies offer great promise for patients and practitioners and may finally open the door to new and effective treatments which up to now have been unavailable. Several different types of cells may be used, (including stem cells, tissue-derived adult cells and cells of the immune system) depending on the specific treatment. The use of living cells as a medicinal product presents extraordinary challenges in terms of production and current manufacturing protocols are relatively inefficient and limited in scale.  They also require highly-skilled teams of technicians operating in a clean-room environment. As clinical trials progress and more treatments are available for patients, cost-efficient and high throughput manufacturing remains a major challenge. 

The initiative is being led by NUI Galway and Fraunhofer Institute for Production Technology, Aachen. AutoCRAT arises from strong and fruitful collaborations between these partners in the recently completed AUTOSTEM project, which led to the development of a fully automated and closed advanced robotic platform for the industrial-scale manufacture of cell products. The AUTOSTEM concept will now be further developed to include enhanced technologies for a wider array of cell types and products derived from cells. The AutoCRAT system will also include automated testing protocols so that process monitoring and quality control are managed within the robotic platform.  

The AutoCRAT Regenerative Medicine Factory (ARM-F) will produce chondrocytes and stem cells for arthritis treatments using robots for every manufacturing step. It will also generate products based on proteins, RNA and other materials that stem cells produce and which are now understood to be key elements of their therapeutic mechanism. Thus, AutoCRAT will enable the production of cell-based therapeutics on an industrial scale, that is more controlled and at a lower cost compared to existing technology. This will accelerate the development of the cell therapy industry and make these treatments more accessible for the benefit of patients. 

The AutoCRAT project will be led by Mary Murphy, Professor of Regenerative Medicine and a Principal Investigator at the Regenerative Medicine Institute (REMEDI) at NUI Galway. Professor Murphy said: “This is an exciting interdisciplinary project that will develop new cell therapies for arthritis and provide the platform for automated, robot-enabled manufacturing of the cell products to ensure that patients will benefit in the foreseeable future.”

According to Frank Barry, Professor of Cellular Therapy at REMEDI, the adoption of best in class manufacturing protocols is still the most serious obstacle facing the cell therapy industry: “We know from our experience in managing cell therapy clinical trials that the  manufacturing side is inefficient and vulnerable with an unacceptably high cost of goods. The only way the field can progress is through the widespread adoption of highly automated production and testing protocols. AutoCRAT addresses these gaps and will be a game-changing innovation.” 

Other essential contributions will come from:

• Valitacell Ltd (VC), based in Dublin will establish automated quality control tests for the automated factory.
• The University of Gothenberg and Leiden University Medical Center will work with REMEDI to develop and test these new arthritis therapies.
• Essen University Hospital and the University of Genoa will develop methods to produce EV-containing, cell-free therapeutic products for arthritis in the automated system.
• Panaxea BV will determine the costs of production and delivery of the developed therapies. They will also assess the potential benefits of an effective cell therapy for osteoarthritis to patients and their families as well as the broader European and worldwide economies.
• Pintail Ltd will assist with the management and administration of the Project and will ensure that AutoCRAT output is disseminated effectively to our target audience.

The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 874671. The material presented and views expressed here are the responsibility of the author (s) only. The EU Commission takes no responsibility for any use made of the information set out.