The Biotherapies Institute has privileged access to two structures, bioproduction and quality control, essential to successfully carry out the clinical development of innovative therapies.
Genethon Bioprod: production of viral vectors to GMP standards
Genethon has a bioproduction centre, Genethon Bioprod, which from 2012 will offer a production capacity of gene therapy products of a clinical grade never achieved. Its mission: produce gene therapy treatments for clinical trials conducted in France or abroad with the strictest compliance to regulatory requirements of pharmaceutical products.
- Genethon Bioprod in figures
– 5000 m2 dedicated to the bioproduction and control of gene therapy products including 4 production suites totalling 500 m2
– Production of 20 clinical batches per year at full capacity
– Up to 800 litres of culture in bioreactors for AAV type products (4 bioreactors of 200 litres)
– Up to 100 litres of culture for lentivirus type vectors
GenoSafe: evaluation of the efficacy and safety of biotherapeutic products
Created by the AFM-Telethon and Genethon, GenoSafe is a services company specialised in the evaluation of the efficacy and safety of biotherapeutic products.
From the different research stages to clinical studies, GenoSafe offers support in study design, development and validation of trials, in compliance with regulatory requirements.