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.
Refining and validating the consumable cassette and core instrument to meet GMP specifications for on-site CAR-T production is performed in this working package: partners will iterate on the Point-of-Care (PoC) - cell and gene therapy cassette design (affinity capture, washing, concentration) and verify cell-isolation performance (purity, viability, yield) across multiple donor samples. Standardized quality-control cartridges and protocols will be developed to automate cell counts, viability checks, and contamination assays, by stakeholder feedback from WP8. Finally, a Digital Twin will integrate process and quality control data into hospital EHR/LIMS systems, enabling real-time interoperability and streamlined clinical workflows.
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.
Christian brings over 16 years of expertise in biotechnology and cell therapy, complemented by deep knowledge in antibodies, small molecules, and exosomes. His career spans from agile small biotech environments to large pharmaceutical companies, giving him a well-rounded perspective across the industry. He also has more than a decade of experience in clinical operations and clinical development.
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Theresa is a biochemist with broad experience in clinical and research environments, including roles at a hospital, a contract research organization (CRO), and laboratories specializing in CAR-T cells and cell selection. At TQx, she is responsible for experimental work, laboratory organization, and scientific presentations. Her background reflects a strong focus on biomedical researchand translational applications.
TQ Therapeutics
Sabine’s expertise is in building bridges between biological/medical and engineering topics. She has 14 years of experience in the field of biotechnology and cell therapy, with deep expertise in technical (medical) device and consumables product development, as well as process development for cell and gene therapy manufacturing. Sabine is looking forward to contributing to the EASYGEN work and driving innovative CAR-T technologies forward.
Christian has a background in immunology with over 16 years of experience in cell therapy product and process development within biotech and pharma. During his past positions, he gained strong experience in the scientific management of various aspects of technology and cell product development to bridge concept, (pre-)clinical development, and implementation.
Christin’s expertise at TQ Therapeutics lies in the field of venture building and commercial strategy, with over 8 years of experience in strategic consulting within the pharmaceutical and life science industry. She is excited and proud to be a member of EASYGEN and to work together with world-leading individual sand institutions to bring CAR-T therapies to patients in need, when they need it.
Stefan has over 15 years of experience in biotechnology and cell therapy, with specific expertise in GMP-compliant manufacturing and supply chain management for materials used in cell and gene therapy. As a CMO manager, he works closely with external partners to produce essential components needed during the cell & gene therapy generation process.
