WP4 defines and validates patient eligibility criteria to identify new cohorts who stand to benefit from the modular CAR-T device, leveraging clinical expertise and data analytics to model anticipated outcomes. A comprehensive market and competitor analysis maps current trends, barriers to entry, and growth projections, informing optimal positioning within healthcare systems. Finally, insights from WP2 are used for exploitation and sustainability strategies that outline clear commercialization pathways, partner engagement, and scalable roll-out plans to ensure long-term integration and impact of the innovation.

Same-day CAR-T production is established and refined through the comparison of novel vector and gene-editing strategies with classical methods. Both processes are then standardized to ensure consistent, clinical-scale use. It develops cutting-edge analytical assays - leveraging CRISPR off-target profiling, 3D ex vivo efficacy screens, and cytokine-release monitoring - to qualify edited cells for safety and potency. Finally, it conducts paired comparisons of the new rapid workflow versus traditional ex vivo culture to demonstrate equivalence or superiority in product quality.