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Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.
On Oct. 22, 2012, a consortium in France announced the establishment of Europe's first ever industrial manufacturing facility dedicated to the large-scale production of novel, advanced cell-based therapy medicinal products.
On Oct. 22, 2012, a consortium in France announced the establishment of Europe’s first ever industrial manufacturing facility dedicated to the large-scale production of novel, advanced cell-based therapy medicinal products. The plant, located in Les Ulis, near Paris, at the site of the French biopharmaceutical company LFB Biotechnologies, has the capacity to produce 3000 to 5000 therapeutic batches per year. The facility will be used for innovative R&D projects on autologous and allogeneic cell therapies that are progressing from early clinical research stage up to industrial production.
The facility project, known as C4C, is coordinated by CELLforCURE, a subsidiary of LFB Biotechnologies, and will involve two biotech companies—Celogos and CleanCells—as well as seven public organizations and university medical centers. Members of the consortium have invested EUR80 million (US$104 million) in the project alongside EUR30 million (US$39 million) public-sector financial aid provided by OSEO, France’s state innovation agency. The project seeks to provide an efficient pharmaceutical and industrial tool for improving patient access to cell therapies. Academic, public and private sector stakeholders will have access to the new facility for routine production of phase III clinical trial batches and commercial batches of new cell therapy products.
Five products are currently under development, with the first batches expected in late 2013, according to a press release.
The industrial manufacturing facility will be validated through the production of these five innovative cell therapeutics and aims to meet the criteria set out by the European and North American health authorities and regulatory agencies. In addition to the C4C project’s own cell therapy products, the facility will offer custom manufacturing services.