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MTI - Right

    Plateforme de Médicaments de Thérapie Innovante de l’EFS

    L’EFS Bourgogne Franche-Comté (BFC) est un établissement pharmaceutique autorisé à produire des Médicament de Thérapie Innovante (MTI).

    L’unité RIGHT collabore étroitement avec la plateforme de production de MTI de l’EFS BFC, une des 4 plateformes de production de l’EFS.

    Cette plateforme dispose de 2 salles blanches permettant la production des MTI. Elle permet de prendre en charge la production des nouveaux médicaments biologiques développés par l’unité RIGHT. Elle intervient après la Plateforme d’Innovation en Biothérapie de l’EFS qui permet de passer du médicament « grade recherche » au médicament « grade clinique ».

     

    Deux études cliniques utilisant des médicaments biologiques ont été menées par le passé grâce au partenariat entre l’unité de recherche et la plateforme de production. Il s’agit de l’étude TKO (gène suicide pour prévenir la maladie du greffon contre l’hôte) et l’étude NK-EGFR01 (ClinicalTrials.gov Identifier: NCT02845999, injection portale de cellules NK allogéniques et d’un anticorps cetuximab dans les cancers gastro-intestinaux présentant des métastases hépatiques).