Gene therapy: CELLforCURE can manufacture products
Manufacturing authorization of gene therapy medicinal products granted to CELLforCURE, the LFB group subsidiary specialized in innovative therapies
CELLforCURE, a pharmaceutical establishment since October 2013 for the manufacturing of cell therapy medicinal products, was granted a new manufacturing authorization on January 30th, 2015. Delivered by the French national agency for medicines and health products safety (ANSM), this authorization allows now CELLforCURE to manufacture gene therapy drugs.
This new achievement contributes to position CELLforCURE as a major industrial and pharmaceutical player in the new segment of innovative medicine therapy.
Driven by emerging needs in various indications, gene therapy and more specifically the ex vivo gene therapy shows currently a rapid development. In June 2014, CELLforCURE has thus signed with CELLECTIS a partnership for the production of clinical batches of CAR T allogeneic lymphocytes. In the field of cell therapies in 2014, CELLforCURE also signed partnerships with biotech companies like EMERCell and the Clinident Biopharma Institute, and the Public Assistance – hospitals of Paris (APHP).
« The next step for CELLforCURE is now to meet with the regulatory requirements of the FDA, in order to manufacture clinical and commercial batches of advanced therapy medicinal products for the North American market. The company plans to achieve this milestone in the next coming months » Pierre-Noël Lirsac, President of CELLforCURE, said.
« CELLforCURE is one of the European leaders in the field of the production of advanced therapies. The internationalization of its activity is in the straight line with the overall strategy of the LFB group » Christian Béchon, CEO of the LFB group, said.
CELLforCURE was created in 2010 as a subsidiary of LFB BIOTECHNOLOGIES for the production of advanced therapy medicinal products. Located in Les Ulis, near Paris, CELLforCURE is offering both manufacturing activities of cell and gene therapy medicinal products and distribution of some of these products. CELLforCURE, Subsidiary of the LFB Group, has its large scale industrial facility targeting manufacturing for clinical phases and the market, inaugurated on September 10th, 2013.
This industrial platform was established within the frame of the C4C project granted in 2012 by the « Investing in the Future » call for tenders and BPIFrance (ex-Oséo). Total program amounts 80 million euros including the development up to the market of five products developed by SMEs and academic teams.
For more information on CELLforCURE: CELLforCURE.com