Intelligent Manufacturing Platform for Advanced CAR Therapies
| Title | Intelligent Manufacturing Platform for Advanced CAR Therapies |
|---|---|
| Acronym | IMPACT - EC |
| Start date | 2026-09-01 |
| End date | 2031-08-31 |
| Sponsor | European Commission |
| Institution | University of Barcelona |
Associated cell lines
Project Description
The IMPACT project aims to transform the manufacturing of Chimeric Antigen Receptor (CAR) cell therapies in order to accelerate patient access to advanced treatments for haematological cancers and immune disorders. Although CAR therapies have demonstrated high efficacy in treatment-resistant malignancies, their broader adoption is hindered by costly, slow, and highly manual manufacturing processes, inconsistent batch quality, and limited availability of lentiviral vectors (LVs). To address these challenges, IMPACT will develop a digitally integrated, scalable, and patient-adaptable CAR cell manufacturing platform that improves efficiency across the entire value chain. A consortium of 15 partners from 9 European countries will co-develop technological innovations targeting key bottlenecks in production and quality control. Lentiviral vector manufacturing will be increased tenfold through the use of closed fixed-bed bioreactor systems, combined with more sustainable purification and stabilization processes. Quality control will be enhanced using nanotechnology-enabled single-particle sensing, enabling rapid, label-free, and real-time potency assessment. Therapeutic efficacy and safety will be evaluated through an integrated suite of Organ-on-Chip models. These systems will provide predictive insights into therapeutic performance and potential adverse effects while reducing reliance on animal testing. The resulting biological and manufacturing data will be integrated into an AI-driven digital twin representing the entire production process, enabling real-time monitoring, adaptive process control, and full traceability in compliance with GxP standards. IMPACT will also promote skills development and workforce training through cross-sector collaboration, facilitating the uptake of new technologies across the European biomanufacturing ecosystem. Sustainability will be embedded throughout the project through the use of green solvents, reduced plastic consumption, and full life-cycle assessments. Overall, IMPACT will deliver a robust and interoperable platform for next-generation ATMP manufacturing, reducing production time and cost while expanding patient access to personalized CAR cell therapies, and establishing a European blueprint for advanced cell therapy production.