TxCell SA, a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, announces today that it received a Manufacturing Accreditation delivered by the French National Agency for Drug Safety (ANSM). The status has been received for its cell therapy production site in Besançon, France.
The TxCell manufacturing facility, located at the French National Blood Center of Bourgogne Franche-Comté region, is now authorized to produce biological investigational medicinal products in accordance with the European Union Directives 2001/83/EC and 2001/20/EC, as required for the manufacturing of Advance Therapy Medicinal Product (ATMP).
TxCell’s lead autologous Ag-Treg cell-based immunotherapy, Ovasave®, is currently in phase II development for the treatment of Crohn’s disease in patients who are refractory to current treatments. Ovasave has been classified as ATMP since 2009 by the European Medicines Agency (EMA). The newly accredited TxCell manufacturing facility will enable production of pharmaceutical grade batches of Ovasave for the next phase IIb study, planned to start mid-2014.