TxCell, a French biotech that saw its clinical trial go off the rails when French regulators shut down its clinical manufacturing operation, has restarted the trial after turning production over to a contract manufacturer.
The company said Wednesday that it has received approval from EU regulators to restart its Phase IIb clinical trial with its lead product Ovasave in patients with moderate to severe Crohn’s disease that is resistant to other treatments. Part of the approval was based on the company moving manufacturing to MaSTherCell and the CMO having conducted a series of successful validation runs on the product.
TxCell hired the Belgian CMO last year to take on its clinical supplies and potentially commercial manufacturing for its lead candidate after regulators shut down TxCell’s pilot facility in Besançon, France, in June 2015 over mold issues. At the time the plant was closed, TxCell said it expected to make improvements and reopen its facility, but after a new CEO took over, it decided to go the CMO route.
Since then, the company has picked contract manufacturer PCT to handle its clinical supply manufacturing in the U.S.
- here’s the announcement
CMO helps TxCell move forward with clinical supplies after pilot plant closed
Contract manufacturer PCT will handle TxCell production in U.S.
TxCell halts drug production, a decision made with French regulator