épreuve biologique - test de potency

Mesenchymal stem cell (MSC) potency assessment is an essential step to establish the cells 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 (BMSC) 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.

QC/potency offering :

  • 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)
  • Standardized offering
  • Pack 1 (level 1 “standard” analysis) :
    • Clonogenicity
    • Phenotypic analysis
    • Safety and stemness
    • Multipotency/differentiation analysis
  • Test Resistance to Oxidative stress analysis
  • Validated process on fresh cells and on frozen cells (for autologous and allogeneic applications)
  • Platform automated on a number of qualifying MSC tests such as clonogenicity, adipocyte and endothelial differentiation
  • Clinical type RT-qPCR for control ASC/MSC and differentiated ASC/MSC (safety, chondrocyte, osteoblastic and endothelial differentiation)
  • ASC/MSC secretion assays
  • Enzymology test
  • In Vivo Analysis (pilot experiment)-GLP pre-clinical study
  • Custom potency and safety assays according to the project
  • Development of new custom potency and/or safety assays
  • Setting of agreement to collaborate on intellectual property

Requests for support (service provision or research agreement) can be submitted by filling the online submission form.