English
Advanced Therapy Medicinal Products (ATMPs), such as CAR T cell therapies, offer transformative clinical benefits for patients with otherwise untreatable diseases. However, their potential remains severely limited by complex, costly, and difficult-to-scale manufacturing processes, as well as prolonged vein-to-vein times that often exceed several weeks. The proposed project S.O.L.A.R.I.S addresses these critical challenges by further developing and enhancing the functionality of a clinically proven and widely-adopted integrated manufacturing solution for CAR T cells: the CliniMACS (CM) Prodigy Platform. SOLARIS will design, integrate, and validate several innovative modules that transform the CM Prodigy into a digitally enhanced, end-to-end automated, GMP-compatible and aseptically closed manufacturing solution. These modules will be plug-and-play compatible with existing CM Prodigies worldwide, enabling rapid adoption across diverse healthcare and manufacturing environments. Validation will be conducted at six EU ATMP manufacturing hubs, strategically selected to cover a wide range of infrastructures: from established clinical and industrial sites to a newly built facility. This approach will provide a proof-of-concept for accelerated technology transfer, improved process consistency, reduced regulatory and technical risks, and significant gains in cost- and time-efficiency as well as scalability. The consortium integrates technical, clinical, regulatory, and sustainability expertise, ensuring a rapid route to clinical adoption. By advancing the manufacturing capabilities of the hubs, SOLARIS will generate best-practice examples for future EU Centres-of-Excellence, aligned with initiatives such as the European University Hospital Alliance and JOIN4ATMP. SOLARIS will demonstrate how optimized manufacturing can enhance equitable patient access to ATMPs across Europe, strengthen EU competitiveness in advanced therapies, and contribute to resilient healthcare systems.
