ATMPs GMP Manufacturing
The MEARY Center has a department dedicated to the manufacture of innovative therapy medicinal products (ATMPs), covering an area of 235 m².
The ATMP manufacture facilities include six ISO 4/5 clean rooms, with level 2 GMO containment.
The production team, works closely with all the MEARY Center teams to provide a wide range of expertise and high-quality services.
Expertises and Services
- Clinical batch production of ATMPs (cellular and gene therapy clinical trials) in compliance with Good Manufacturing Practices (GMP).
- Production in an A to B classified environment.
- Production of various cell types (CAR-T cells, mesenchymal stromal cells, regulatory T cells, cell banks, etc.).
- Process optimization and industrialization (from research grade to GMP grade).
- Supporting research teams, start-ups, and industrial partners in the technological and regulatory development of production processes, in collaboration with all teams at the MEARY Center.
Approvals
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Installation approval L2-1491 for use of genetically modified organisms in contained systems
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ANSM authorization TIE/19/O/001 (Eudra GMP)