ATMPs GMP Manufacturing
Under the direction of Dr. Camille Maheux, the MEARY Center is equipped with an ATMPs manufacturing department spanning a surface area of 2500 sq ft.
The ATMPs manufacturing facilities consist of 6 ISO 4/5 clean rooms with type 2 GMO containment.
The manufacturing team, with five years of recognized expertise, works closely with all MEARY teams to offer a wide range of skills and high-quality services in the field of ATMPs.
Expertises and Services
- Manufacturing of ATMPs clinical batches (cell therapy and gene therapy clinical trials) in compliance with GMP
- Manufacturing in a A in B classified environment
- Manufacturing of different cell types (CAR-T cells, Mesenchymal Stromal Cells, Treg cells, cell banks, etc)
- Optimization and industrialization of manufacturing processes (from research grade to GMP grade)
- Support for research teams, start-ups and industrialists in the technical and regulatory development of the process
Autorisations
- GMO approval n°5691 (Ministry of Higher Education, Research and Innovation)
- Authorisation ANSM TIE/19/O/001 (Eudra GMP)