Scientific scope and capacities.
EATRIS-CZ supports ATMP development through cell and tissue engineering, neuroregeneration platforms, advanced preclinical models and clinical translation environments, complemented by GMP/GxP-aligned facilities and know-how within clinical partners (including haematology and transfusion medicine settings). This enables patient-specific/stratified ATMP concepts to be progressed with appropriate quality documentation and translational planning.
Main services to users (examples).
- Advanced in vitro and organotypic models for mechanism, efficacy and safety evaluation;
- Preclinical validation packages in GLP-aligned workflows, including structured data capture and reporting;
- Support for ATMP-relevant GMP/GxP readiness, including documentation, process planning and translational study design;
- Clinical-interface support for early feasibility studies and trial preparation in collaborating hospital environments.
Advanced Therapy Medicinal Products represent a new category of medicines with a wide therapeutic potential for treating different types of diseases such as cancer, neurodegenerative and cardiovascular diseases. They include Gene Therapy Medicinal Products, Cell Therapy Medicinal Products, and Tissue Engineered Products. Clinical application of the two latter types is frequently referred to as ‘Regenerative Medicine’. The platform provides the most qualified and state-of-the-art technologies for the critical issues in this development area, such as specialized GMP facilities, imaging facilities for in vivo animal studies, availability of dedicated/tailored animal models, clinical expertise and access to patients for high prevalence and/or rare diseases, as well as to clinical facilities. The platform includes a network of experts for regulatory affairs specialized in the ATMP field to ensure compliance with the preclinical and clinical development guidelines within Europe.
EATRIS-CZ participation
- IEM, ICRC
Major technologies/infrastructures
- GMP production plants, clinical trial units, animal facilities, imaging