CA24114 - EUROPEAN NETWORK OF SoHO ESTABLISHMENTS FOR RAPID AND SUSTAINABLE ACCESS TO ATMPs (BTCs4ATMP)

BTCs4ATMP aims to create an European collaborative network of Blood, Tissue and Cell processing centres (BTCs) involved in the development and/or manufacturing of Advanced Therapy Medical Products (ATMP). This initiative will provide a framework for successful development and validation of cost-effective manufacturing and reliable quality control (QC) testing, in compliance with strict pharmaceutical quality management standards to promote standardisation of procedures and harmonisation of assays by sharing protocols and reagents through biobanks. This strategy not only will boost the state-of-the-art of the research in the fields of cell-based immunotherapy and regenerative medicine but also contribute to Europe’s leadership through medical, scientific, economic, and social development while strengthening Europe’s competitiveness capacities. This network includes all the relevant stakeholders: procurement of substance of Human Origin (SoHO) and processing centres, biobanks supplying starting materials and reagents used in bioprocesses and QC; Good Manufacturing Practice (GMP)-compliant laboratories, immunology experts, safety testing laboratories, chemistry and manufacturing controls, regulatory bodies, National Agencies, and ethics experts. The challenge will be approached by networking with all the stakeholders’ involved sharing knowledge, standardizing methodology and developing an educational training programme for researchers, technicians and clinicians.

BTCs4ATMP is promoting the participation of developers from Inclusiveness Target Countries (ITC), who will have access to research facilities, training courses, mentoring of ITCs and YRIs who will participate spreading excellence and widening the programme. Furthermore, key leadership positions in the Action Management are reserved to ITC’s YRI.

BTCs4ATMP will pioneer approaches that will foster developments to facilitate patient access to ATMPs.