Clinical grade Tissue and Cell Sourcing
Through a strong partnership with Hospital/Clinic network, we propose a wide range of Good Manufacturing Practices (GMP) grade materials to facilitate your clinical Development.
Cell/Tissue from healthy Donors
Various Cell Lines
Cells from patients cohort through local clinicians network
Process and Analytical Development
From UpStream to DownStream Process Development, we provide tailored solutions to bring robustness, cost-control and time-saving to your process.
- Optimization of process parameters
From 1mL to >50L
Strong experience in cell process technologies (isolation, Harvesting, Washing, Filtration, Concentration, Formulation, Cryoconservation…)
Our Quality by Design (QbD) approach defines the framework for cell product production. We pay close attention to the product specification parameters in order to better characterize the manufacturing process and the quality of the final product while respecting regulatory compliance.
- Custom-made potency assay
- Definition of Critical Quality Attributes (CQA)
- Safety, Identity and therapeutic performance
Manufacturing
Our experienced Team is working daily in a new state-of-the-art facility authorized by the National Agency for the Safety of Medicines and Health Products (ANSM). We provide services from Technology Transfer to Clinical manufacturing with fully equipped R&D labs, QC labs and Grade-B cleanroom suites to advance ATMPs from lab to market.
- 3 Grade B cleanroom suites fully equipped
- R&D laboratories
- Dedicated QC labs
- Fully qualified equipments
==> More about our GMP capabilities…
Analytics testing
- Identity
- Safety
- Potency
Regulatory Support
The Quality by Design approach used at Cell-Easy corresponds to the requirements of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the submission of Investigational Medicinal Product Dossier (IMPD) or Investigational New Drug (IND) application.
Our qualified Quality Assurance (QA) team supported by a robust Quality Management System (QMS), has all the necessary procedures in place for Cell Bank and Drug Substance batch release and for Drug Product batch certification for use in clinical trials. Our QMS combined to stringent QC procedures allows for complete control and traceability of your ATMP manufacturing process.
Case study
Addressing Common Regulatory Roadblocks in ATMP Clinical Trials
CONTACT US
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Contact
Tel : +33 534 276 550
Address : Cell-Easy SAS, 4 bis avenue Hubert Curien, 31100 Toulouse, France
Mail : info@cell-easy.com