SOLARIS

Advancing scalable CAR T cell manufacturing across Europe

Description

Advanced Therapy Medicinal Products (ATMPs), such as CAR T cell therapies, offer transformative clinical benefits for patients with otherwise untreatable diseases, such as various cancers and genetic disorders. However, the manufacturing process remains time consuming, complex, costly, and difficult-to-scale, severely limiting their potential.

To help overcome these challenges, S.O.L.A.R.I.S. will develop and enhance the functionality of a clinically proven and widely adopted integrated manufacturing solution for CAR T cells: the CliniMACS Prodigy® Platform. S.O.L.A.R.I.S. will develop several fully automated modules that will be compatible with existing systems worldwide. The modules will be designed to optimize performance, robustness, transferability, scalability and overall accessibility of CAR T cell manufacturing. They will also be validated for performance and rapid adoption across six European ATMP manufacturing sites. To ensure that regulatory requirements for technology development are met in due time and to facilitate the adoption of the new modules, a major focus of S.O.L.A.R.I.S. will be to design and implement a proactive regulatory strategy.

S.O.L.A.R.I.S. will demonstrate how optimized and sustainable CAR T cell manufacturing can enhance equitable patient access to ATMPs across Europe, strengthen EU competitiveness in advanced therapies, and contribute to resilient healthcare systems.

Coordinator

Dr. Ian Johnston

Miltenyi Biotec

Email