QC/potency


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 (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.