TxCell, a biotechnology company specializing in the development of personalized cell-based immunotherapies, has received manufacturing accreditation status of its cell-therapy production site in Besancon, France, from the French National Agency for Drug Safety (ANSM). TxCell develops antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases.
The company’s manufacturing facility, located at the French National Blood Center of Bourgogne Franche-Comte 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). The company will now be able to manufacture batches of Ovasave (its lead autologous Ag-Treg cell-based immunotherapy) for clinical testing in patients with Crohn’s disease.
The 440 m2 facility includes 120 m2 of cleanroom suites of which 80 m2 are Grade B suits under GMP EU classification. TxCell has a manufacturing capacity of more than 20 cell therapy batches in parallel.
“This manufacturing accreditation from ANSM is a key milestone in the planned future development and growth of TxCell,” said Damian Marron, CEO of TxCell, in a press statement. “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.”