LabHPEC laboratory consolidates its strategic position for the development of Advanced Therapeutic Medicinal Products (ATMP)
LabHPEC laboratory (Laboratoire d'HistoPathologie Expérimentale et Comparée)/STROMALab (CNRS/EFS/ENVT/Inserm/UT3 Paul Sabatier) renews its level A GLP (Good Laboratory Practices) Compliance recognition by the French Drug Safety Agency (ANSM)
This renewal strengthens its strategic position within the Regional Regenerative Medicine domain for the development of ATMP.
It remains the first French academic laboratory in pathological anatomy recognized compliant with GLP by the ANSM and a major player in the conduct of histopathological studies of regulatory non-clinical phases in the development of ATMP.
October 2019- ANSM renews GLP compliance recognition at level A (the highest). This recognition, a guarantee of excellence in laboratory activities, enables LabHPEC to be a major player in the conduct of histopathological studies for regulatory non-clinical phases in the development of ATMP. Tomorrow’s medicine, cell based therapy has high hopes for the cure of many diseases for which today there is no satisfactory therapeutic solution. This medical revolution is already underway since many clinical trials using these advanced therapeutic medicinal products (ATMP) are yet in progress in the world (more than 1300) and that the first therapeutic products are already marketed.
This field of Medicine and health of the future is one of the anchors of the Regional Innovation Strategy (SRI) of the Occitania region. The Occitania region consolidates its national position in the field of cell therapy by initiating a strong coordination of the major players in this sector such as hospitals, researchers, industrialists and start-ups.
As part of its membership of STROMALab (CNRS / EFS / ENVT / Inserm / UT3 Paul Sabatier) and the regenerative medicine sector, integrated into the Regional Innovation Strategy, the ENVT LabHPEC had launched, in 2015, in an ambitious GLP compliance program. The qualifying study, funded by STROMALab to assess the biodistribution and toxicity of frozen mesenchymal stem cells (MSCs), was conducted with a multi-site organization involving different actors in Toulouse: the Centre Régional d'Exploration Fonctionnelle et de Ressources Expérimentales (CREFRE – Inserm/UT3 Paul Sabatier), Scanelis® compagny (PCR analysis) and the Etablissement Français du Sang (GMP production of mesenchymal stem cells). All partners had validated with this study, their GLP level A compliance for the organization of multi-site studies.
Since 2017, this conformity leveraged the LabHEPC, to position itself, at European level, as the first French academic laboratory in pathological anatomy GLP. Compliance with the GLP standard is a guarantee of the quality of the organization and operation of the test facilities and therefore of the quality, reproducibility and integrity of the data of the studies carried out.
LabHPEC consolidates its strategic positioning on the conduct of regulatory non-clinical studies necessary for the marketing of human Advanced Therapeutic Medicinal Products (ATMP). Its current partners and future customers will thus directly benefit, for their histopathological studies, from the higher level of compliance meeting the most demanding standards, whether they work themselves under GLP conditions or not. This recognition of the highest level of GLP compliance, internationally recognized, has allowed LabHPEC to be identified as a partner of choice for manufacturers or for R & D organizations involved in drug development.