Advanced Therapy Medicinal Products (ATMP) development

European Infrastructure for Translational Medicine (EATRIS)

Netherlands

Service ID:

EP227S1
Service description

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.

Sector
Biotechnology
Health and medical care
Technology Readiness Level
TRL 1 – Basic principles observed
TRL 2 – Technology concept formulated
TRL 3 – Experimental proof of concept
TRL 4 – Technology validated in lab
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
Financial requirements

Fees are charged according to the costs of the service/study. EATRIS is a non-profit and all our 56 ATMP centres are academic or non-profit research facilities specialised in ATMP.

Disclaimer related to service

All services are subject to availability and mutual interest of the laboratory identified as the suitable service provider. 

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