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Centre MEARY
AP-HP MEARY Center for Cell and Gene Therapy is among the leaders in the manufacturing of ATMPs, offering cutting-edge expertise to clinicians, research teams, as well as industrial partners for the support and execution of their cell, tissue, and gene therapy clinical trials.
The MEARY Center offers its services within : A department of ATMP manufacturing, - Assistance to research teams, start-ups and compagnies in the technical and regulatory development of the process - Manufacturing of clinical batches of investigational medicinal products (cell and gene therapy clinical trials) in compliance with GMPs - Manufacturing in an environment classified A in B - Manufacturing of different cell types (CAR-T cells, mesenchymal stromal cells, stromal vascular fraction, cell bank, etc.) - Optimization and industrialization of manufacturing processes (from research grade to GMP grade) A quality management system department, - Assistance in the filing of technical and regulatory dossiers for ATMPs and investigational drugs - Set up of clinical trials, technical and regulatory management - Management of a pharmaceutical quality system - Good Manufacturing Practices (sterile drugs, investigational medicinal products, ATMPs) - Audits (internal and external). A quality control department, - Appearance - Safety with sterility test - Safety with non-sterility tests (mycoplasma and endotoxins) - Identity, purity and quantity - Potency testings - Environmental controls (microbiological and special controls)
Contact
1 Avenue Claude Vellefaux
75010 PARIS
France
+33 1 71 20 75 38
+33 1 71 20 75 30
Activities
- Manufacturer
- Research structure
- Analytical Process, Quality assement, Quality Control
- Cleaning
- CGMP
- Cross contamination
- Sterility
- Deviations
- Quality control
- Contaminants detection
- Safety for gene-edited cells : translocation
- Safety for gene-edited cells : anti-nuclease response
- Safety for gene-edited cells : cytokine-independent growth
- Bioproduction
- Bioproduction
- Scale-Up
- Automate manufacturing
- Automated high-throughput microbioreactor system
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Non-GMP pilot batch
- GMP batch
- Cell acquisition
- Autologus
- Allogenic
- Cell Bank
- Tissue acquisition
- Off the shelf
- Apheresis
- Target cell isolation
- iPS reprogrammation
- Differentiated Cell
- Production Cell
- Safety donor-derived therapies
- Cell modification
- Gene modification
- Directed reprogrammation
- Construct introduction
- Cell Expansion
- Bioreacteur
- Wave
- Cell factory
- Other
- Purification / extraction
- Purification / extraction
- Formulation
- Formulation
- Conditionning
- Conditionning
- Transport
- Transport
- Analytical Process, Quality assement, Quality Control
- Cleaning
- CGMP
- Cross contamination
- Sterility
- Deviations
- Quality control
- Contaminants detection
- Safety for gene-edited cells : translocation
- Safety for gene-edited cells : anti-nuclease response
- Safety for gene-edited cells : cytokine-independent growth
- Gene modification
- Gene modification
- Adoptive T cell Major Challenges in Solid Tumors
- Tumor/Ag heterogeneity
- Tumor associated Antigen
- Miroenvironment
- Delivery/homing
- Combinations
- Bioproduction
- Bioproduction
- Scale-Up
- Automate manufacturing
- Automated high-throughput microbioreactor system
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Non-GMP pilot batch
- GMP batch
- Cell acquisition
- Autologus
- Allogenic
- Cell Bank
- Tissue acquisition
- Off the shelf
- Apheresis
- Target cell isolation
- iPS reprogrammation
- Differentiated Cell
- Production Cell
- Safety donor-derived therapies
- Cell modification
- Gene modifcation
- Directed reprogrammation
- Construct introduction
- Cell Expansion
- Bioreacteur
- Wave
- Cell factory
- Other
- Purification / extraction
- Purification / extraction
- Formulation
- Formulation
- Conditionning
- Conditionning
- Transport
- Transport
- Analytical Process, Quality assement, Quality Control
- Cleaning
- CGMP
- Cross contamination
- Sterility
- Deviations
- Quality control
- Contaminants detection
- Safety for gene-edited cells : translocation
- Safety for gene-edited cells : anti-nuclease response
- Safety for gene-edited cells : cytokine-independent growth
- Bioproduction
- Bioproduction
- Scale-Up
- Automate manufacturing
- Automated high-throughput microbioreactor system
- Supply chain logistics
- Tracking process
- Monitoring logistics
- Non-GMP pilot batch
- GMP batch
- Cell acquisition
- Autologus
- Allogenic
- Cell Bank
- Tissue acquisition
- Off the shelf
- Apheresis
- Target cell isolation
- iPS reprogrammation
- Differentiated Cell
- Production Cell
- Safety donor-derived therapies
- Cell modification
- Directed reprogrammation
- Cell Activation
- Cell Expansion
- Bioreacteur
- Wave
- Cell factory
- Other
- Purification / extraction
- Purification / extraction
- Formulation
- Formulation
- Conditionning
- Conditionning
- Transport
- Transport