Résumé :
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Genethon has been provided with GMP manufacturing facilities of about 600 m2 for the production of viral vectors for human gene therapy trials. All steps are performed on the site: plasmid production, cell banking, cell culture, purification and final filling. Genethon can assume a complete process for AAV, HIV and MLV viral vectors. Cell culture can be performed in flasks (up to 24 CF 10 cell factories) or bioreactors (up to 10 liters volume). The viral vectors are purified by ion exchange or affinity chromatographic steps. The batch size, depending on the process, is from 1013 to 1014 total physical particles. The process covers 3 to 5 weeks. The production site is operational since 2005. Genethon is producing clinical batches for four inner projects but also for outer customers, depending on the available production slots. Genethon’s facilities are also designed for feasibility studies in pilot laboratories before GMP production. The production is performed on two independent sites: one is L2 classified and the other one L3. In 2010, new facilities will be built for Genethon and designed for large scale production and will be equipped with 300 liters bioreactors and 4 independent production suites. It will be located in Evry.
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