Centre MEARY de Thérapie Cellulaire et Génique de l'AP-HP
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Contact
Hôpital Saint-Louis, 1 avenue Claude Vellefaux
75010 Paris
France
Directeur
About us
AP-HP MEARY Center for Cell and Gene Therapy is a leader in the manufacturing of Advanced Therapy Medicinal Products (ATMPs), offering cutting-edge expertise to industrial partners to support and carry out their cell, tissue and gene therapy clinical trials. It supports industrial partners in the technical and regulatory development of their processes.
Business offer
A Cellular and Gene Therapy Center dedicated to the manufacturing of ATMPs:
- Assessment of the project and its development stage
- Analysis of the manufacturing process and quality controls to be implemented
- Drafting of contracts and quality agreements
- Technology transfer
- Drafting of regulatory dossiers
- Clinical trial set-up and batch manufacturing
Activities
- Pre-industrial demonstrator
- Cell origin
- Single donor
- Pool of donors
- Cell Banking
- IPs
- MSC
- CD34 + HSC cells
- Apheresis
- Target cell isolation
- Differentiated Cell
- Safety donor-derived therapies
- Cell modification
- Cell Activation
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy
- CMC/analytical quality assessment, quality control
- Sterility
- Deviations
- Contaminants detection
- Bioproduction engineering
- Cell Expansion
- Stirred tank Bioreactor
- Wave bioreactor
- Microcarrier-based culture
- Capsules culture
- Scale-Up
- Process optimization
- Automated manufacturing
- On-line monitoring
- Non-GMP expansion
- GMP expansion
- Other
- Cell procurement
- Autologous
- Ex Vivo & In Vivo Strategy
- Ex Vivo & In Vivo Strategy
- Bioproduction/CMC/Analytical Quality Assessment, Quality Control
- Bioproduction
- Scale-Up
- Automated manufacturing
- Non-GMP pilot batch
- GMP batch
- Sterility
- Quality control
- Contaminants detection
