TxCell SA has announced that it has 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.
“This manufacturing accreditation from ANSM is a key milestone in the planned future development and growth of TxCell,” said Damian Marron, Chief Executive Officer. “This is essential for scaling up manufacturing of TxCell’s lead product Ovasave for our forthcoming Phase IIb in refractory Crohn’s Disease. This in turn allows us to accelerate the development of all our innovative, personalized cell-based immunotherapies. These therapies target niche and orphan indications for which there are few or no treatment options and a high unmet medical need. There are currently 160,000 such patients per year in Europe and in the US for Crohn’s Disease alone.”
“This Manufacturing Accreditation recognizes the quality of our facility designed to produce highly innovative, personalized cell based immunotherapy products.” said Eric Pottier, Executive Director Supply Chain & Qualified Person. “This is a reward for the ongoing investment by TxCell and the TxCell team. We also wish to thank the French National Blood Center for contributing their strong expertise in the cell therapy production field, in particular Dr. Pierre Tiberghien, Scientific Director, and Dr. Pascal Morel, Director.”
The TxCell manufacturing facility contains 440m² of premises. These premises includes 120m² of cleanroom suits of which 80m² are Grade B suits under GMP EU classification, TxCell has a manufacturing capacity of more than 20 cell therapy batches in parallel.