Since 2005 Genethon has had its own manufacturing capacity for the production of gene therapy vectors according to the standards of Good Manufacturing Practices.
In 2013 Genethon opened a new production center, Genethon BioProd, which is authorized to operate as a Pharmaceutical Establishment.
Genethon BioProd, occupies a 5000 m2 building and is one of the most important centers dedicated to biomanufacturing and quality control of gene therapy products. At full capacity, it will be able to produce nearly thirty clinical batches of vectorized drugs per year. Its mission is to manufacture therapeutic candidates for clinical trials in France or abroad in strict compliance with regulations for pharmaceutical products.
The building of Genethon Bioprod, at a total cost of €28 million, was funded by:
- The Association Française contre les Myopathies (AFM-Telethon): €5 million
- Ile-de-France Regional Council: €8 million
- Essonne Departmental Council: €7 million
- Genopole®: €8 million
Genethon BioProd has unique expertise in the quality control of viral vectors for clinical application and offers cutting-edge experience in bioprocess development which enables it to:
- transfer existing processes efficiently or alternatively;
- develop innovative processes and analytical methods;
- introduce paradigm shifts for scalability, purity and biosafety.