Thérapie génique; vecteurs viraux; développement de procédés; développement analytique; lot BPF; contrôle qualité

Consortium préindustriel des vecteurs de thérapie génique

Démonstrateurs (DPBS)


Informations générales

Référence projet : 10-DPBS-0001
RST : Matthias HEBBEN
Etablissement Coordinateur : Genethon
Région du projet : Île-de-France
Discipline : 5 - Bio Med

Aide de l'ANR 19 994 100 euros
Investissement couvrant la période de avril 2011 à décembre 2019

Résumé de soumission

GENETHON and ABG-EFS, each, were running a clinical-grade vector production site that complies with Good Manufacturing Practice (GMP) and were both granted and registered by regulatory bodies as pharmaceutical manufacturer sites in 2013. To our knowledge, both PGT partners are the first not-for-profit entities in Europe to obtain such registration in the field of viral vector manufacturing. Practically and with respect to PGT’s main mission, it allows us to manufacture, export and release advanced-therapy medicinal products to any European investigators. In November 2016, the existing bioproduction platform of Genethon (GBP) was integrated in the new project supported by the AFM-Telethon and the « SPI – Sociétés de Projets Industriels » equity fund, headed by Bpifrance as part of the Investments Program for the Future. The two subjects decided to co-fund the creation of the largest European center, named YposKesi, for the development and manufacturing of gene and cell therapies.- WEBSITE: A dedicated website was launched in 2013 and the “actu” section is updated regularly. It can be viewed at: A press release on PGT was published on June 4, 2015 in the newspaper “Les ECHOS”. The PGT consortium was present at the ESGCT congress in Florence from 18-21 October 2016 and at the ASGCT congress in Washington, DC, May 4-7, 2016. LIST OF PROJECTS: After 69 months of operational development, all partners have agreed in November 2016 to focus on specific, productive and competitive projects. This updated program was discussed and validated at the last Costrat, in November 2016 and submitted to the ANR on February 2, 2017. - COMPLETED PROJECTS: Sixteen projects initially listed in the overall program were now completed. A brief description of the results for each program closed in 2016 is available in this report. - CLINICAL VECTOR CAMPAIGNS: Since 2013, 22 manufacturing campaignsare in the pipeline at different development stages.

L'auteur de ce résumé est le coordinateur du projet, qui est responsable du contenu de ce résumé. L'ANR décline par conséquent toute responsabilité quant à son contenu.

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