GMP certificates for CELLforCURE
On july 19, 2016, CELLforCURE was granted from the French Health and Medecine Agency by two GMP certificates : one addressing the manufacturing of investigational and marketed cell therapy products and the other addressing the manufacturing of investigational gene therapy medicinal product under the following numbers : HPF/FR/165/2016 certificate and HPF/FR/166/2016.
This certificate is confirming the skills and the know-how of CELLforCURE in the manufacturing of cell and gene therapy products as a pharmaceutical establishment. The whole company was inspected by the French Health and Medecine Agency, from the pilot zone to the GMP production zone, along with the production environment and control quality. The authorization of CELLforCURE to manufacture in les Ulis cell and gene therapy productswas initially granted in 2015.
The GMP certificate concerning these both topics is a main step in industrial and commercial CELLforCURE activitie ramp-up and insures its worldwide position. “With this certificate, we now achieve the level of skills needed to develop a CDMO of such a size, and to carry out our goals” says Pierre-Noël Lirsac, CELLforCURE CEO“. This is a recognition of the work accomplished by our teams and of the individual and collective know-how” adds Sébastien Renouf, CELLforCURE Chief Pharmaceutical Officer