Bioproduction

Since 2005, Genethon has been running a clinical-grade vector production site that complies with Good Manufacturing Practice (GMP) and has been classified as an ETGC (Gene and Cell Therapy) establishment by the AFSSAPS, the French Healthcare Products Safety Agency.

At the end of 2011, Genethon will open a new bioproduction center called Genethon Bioprod, which will offer unprecedented production capacity for clinical-grade gene therapy products. The mission of Genethon Bioprod will be to manufacture treatment candidates for clinical trials being conducted in France or at international level, while at the same time ensuring the strictest respect for pharmaceutical regulations.

Facilities

  • 5,000 m² for bioproduction and gene therapy product monitoring
  • 15 different HVAC engines (air 100,000-500,000 times ‘cleaner’ than atmospheric air)
  • 3 km of air ducts
  • Building design compliant with HEQ (High Environmental Quality) standards

Laboratories

  • Approximately 2,500 m² of Level 3 classified containment laboratories suitable for handling GMO and virus systems
  • 4 production suites totaling 500 m²
  • 2 aseptic filling suits with Class A isolators
  • 120 m² of pilot laboratories for industrial scale implementation of optimized manufacturing processes
  • 500 m² of GPP-compliant quality control laboratories

  • 200-liter production system (bioreactor)

Production Capacity

  • 20 clinical batches a year at full capacity
  • Up 800 liters of bioreactor capacity for AAV product cultures (four 200-liter bioreactors)
  • Up to 100 liters of culture capacity for lentiviral vectors

 

The building of Genethon Bioprod, at a total cost of €28 million, was funded by:

Annual running costs, estimated at €5-8 million, will be financed by AFM using donations from the annual Telethon.