Advanced Therapy Medicinal Products (ATMP) development

EATRIS's infrastructure integrates expertise across all ATMP classes, providing a comprehensive range of resources to support translational research from preclinical development to clinical implementation. We offer access to cutting-edge technologies, including GMP-compliant manufacturing for cell and gene therapies, innovative preclinical tools for evaluating safety and efficacy, and advanced imaging techniques for in vivo studies such as PET-CT and PET-MRI for cell tracking and biodistribution analysis. Our expertise spans genome editing technologies, including CRISPR, base editing, prime editing, TALENs, and zinc-finger nucleases, as well as novel RNA-based therapeutics. EATRIS supports disease-specific research through advanced model systems, including cancer organoids, organ-on-a-chip platforms, patient-derived xenografts, and multifluidic devices for immune surveillance in the tumour microenvironment. We also facilitate regulatory assessment, offering guidance on ATMP immunogenicity, efficacy, and toxicology to streamline product development. Our infrastructure includes clinical trial centers for early-phase (Phase I/II) studies in collaboration with university medical centers, fostering direct interaction between clinicians and translational researchers. We provide essential services such as scientific advice, Target Product Profile (TPP) and Investigational Medicinal Product Dossier (IMPD) development, and preclinical validation using disease-specific animal models, including primates. Additionally, EATRIS enables upscaling and GMP production of ATMPs, including viral vector manufacturing, ensuring a seamless transition from research to clinical application. Our in vivo imaging technologies, such as Mass Cytometry Imaging (MCI), ultrasound, and PET-MRI, allow for detailed monitoring of immune responses and therapeutic efficacy.