has received a certificate of GMP compliance by the French National Agency for Drug Safety (ANSM) for its cell therapy manufacturing facility in Besançon, France. The GMP compliance covers the manufacture, testing, blinding activities and release of investigational biologics and cell therapy products. It also authorizes the manufacture of Phase IIb clinical batches of Ovasave, a personalized cell-based immunotherapy for refractory Crohn’s disease, which is scheduled to start in 1H14.
“This certificate of Good Manufacturing Practices compliance is a result of the outstanding work of the TxCell’s teams. We have now achieved another of our strategic objectives to be able to offer a new therapeutic option for patients without effective treatment,” said Eric Pottier, vice president of Supply Chain & Qualified Person, TxCell.