S.O.L.A.R.I.S. brings together 13 partners from across Europe, spanning industry, healthcare, research, and regulatory authorities. Together, they will improve the efficiency, robustness, and scalability of CAR T cell manufacturing, helping to make these therapies available to more patients. While advanced therapy medicinal products (ATMPs), including CAR T cell therapies, have expanded treatment options for patients with severe diseases, their availability remains limited due to complex, labour-intensive, and costly manufacturing processes that are difficult to scale.
"CAR T therapies have shown strong clinical potential, but broader patient access depends on making manufacturing faster, more efficient, and more scalable,” says Ian Johnston, Project Coordinator at Miltenyi Biotec. “S.O.L.A.R.I.S. supports the implementation of technological innovations in both point-of-care and centralized manufacturing scenarios.”
Over the next four years, S.O.L.A.R.I.S. is set to develop and implement seven new modules into CliniMACS Prodigy®, the automated cell manufacturing platform developed by Miltenyi Biotec. These modules will integrate into the existing system to support a digitally enhanced, highly automated manufacturing workflow that complies with Good Manufacturing Practice (GMP) standards.
The new technologies will be tested and validated at six ATMP manufacturing hubs across Europe, covering clinical, industrial, and newly established production settings. This includes both centralized facilities and point-of-care environments, such as hospital-based manufacturing. This will allow the technologies to be evaluated across different settings, support the development of best practices, and reduce implementation risks.
At the same time, partners will contribute their specific expertise in areas such as clinical application, manufacturing, or technology development. Within S.O.L.A.R.I.S., the UMCG contributes to the testing and validation of new technologies for the production of CAR-T cells in a hospital-based point-of-care setting. The work focuses on applications for ovarian carcinoma and builds on the UMCG’s expertise in the field of CAR-T cell production. Among other things, the project is investigating digital support for the production process, data-driven applications, and further automation of quality control and product release. The goal is to assess how these innovations can be safely and efficiently implemented in clinical practice.
S.O.L.A.R.I.S. will also assess ways to reduce waste, improve resource efficiency, and environmental sustainability in advanced cell therapy manufacturing. In parallel, project partners will work with regulatory authorities to support the future adoption of these technologies in clinical and manufacturing environments.
By combining technology development with validation in real-world settings, S.O.L.A.R.I.S. will support more efficient and scalable manufacturing of CAR T therapies, help improve patient access, and strengthen Europe’s capabilities in advanced cell therapy manufacturing.
