In February 2017, the Agence Nationale de Sécurité du Médicament (ANSM) issued 3 Primo-Conformities to Good Laboratory Practice (GLP) of Status A at the end of a non-clinical Multisite study involving academic and private Toulouse establishments.
As part of the Toulouse regenerative medicine field, included in the Regional Innovation Strategy, STROMALab and LabHPEC (Laboratoire d’HistoPathologie Expérimentale et Comparée) are embarking on the GLP adventure to conduct non-clinical regulatory trials for cell therapies. These actors take on board with them two other organisations, one academic (CREFRE, Inserm’s zootechnics service) and the other private (Scanelis, PCR analysis laboratory). The study carried out is a biodistribution and toxicity study of ASC (mesenchymal stem cells originated from fat) which was sponsored by STROMAlab as part of the ECellFrance platform (future investment financing).
In view of the various skills required to implement this project, it was necessary to carry out a multi-site study. Participating laboratories have faced several challenges, including the collective and consistent implementation of GLP (OECD principles revised in 1997). Compliance with GLP ensures the reliability of the project’s scientific results and will subsequently allow their inclusion in a regulatory dossier for the development of Innovative Technology Medicines (ITM).
To learn more about this collective work combining scientific excellence and quality, view the poster presented at the congress of the French Society for Quality Assurance (SOFAQ 2018) by clicking here.