QC/potency
Mesenchymal stem cell (MSC) potency assessment is an essential step to establish the cell quality prior to their therapeutic application, and, as such, it is a regulatory requirement. For this purpose, ECELLFrance has developed standards for potency tests and safety controls on cultured MSC from bone marrow (BM-MSC) and adipose tissue (ASC).
ECELLFrance’s QC/potency platform is located in Toulouse. It is a key facility downstream of cell production for safety and quality assessment of the cells.
The service offering consists in two QC/potency packages (level 1 or 2) to choose from, based on the cell therapeutic applications and the aims of the project. Customized QC/potency assays may also be implemented when appropriate. The QC/potency options are discussed with the project carriers following their application. Key QC/potency offering is summarized below.
The platform has a high expertise of MSC/ASC allowing to a personalized service by a team of specialists (experience in over 20 national and European clinical trial programs in cell therapy using MSC).
QC/potency offer
- Clonogenicity (CFU) standardized and validated process on fresh cells and on frozen cells (for autologous and allogenic applications)
- Cell production from human samples, research level culture (classic and differenciation)
- RT-qPCR analysis according to the European Pharmacopeia (EP)
- Safety and multipotency control (hTERT)
- Automated analysis of multipotency by imaging
- Secretion assays
- Genomic analysis in absolute quantification with reference on normal cells
- Upgrading QC assays to the European Pharmacopeia (EP)
- Development and set-up of new QC/potency assays
- In Vivo Analysis (pilot experiment)-GLP pre-clinical study
- Development and set-up of new reserach projects according to collaboration agreement on intellectual property
Requests for support (service provision or research agreement) can be submitted by filling the online submission form.