TxCell SA, a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, has been granted Certificate of Good Manufacturing Practice (GMP) compliance for its cell therapy manufacturing facility in Besançon, France.
The certificate was granted by French National Agency for Drug Safety (ANSM), the French authority for the quality, safety and efficacy of medicines and health products. This certificate follows the Manufacturing Accreditation, also delivered by ANSM on December 3, 2013.
"The certificate of GMP compliance for our manufacturing facility is a key step in TxCell’s development for our lead candidate Ovasave. We believe this is a product that may offer a breakthrough innovation for the treatment of refractory Crohn’s disease. There are currently 160,000 such patients per year in Europe and in the US for Crohn’s Disease alone,” said Damian Marron, chief executive officer, TxCell. “This in turn allows us to accelerate the development of all our innovative, personalized cellular immunotherapies. These therapies target niche and orphan indications for which there are few or no treatment options and high unmet medical needs.”
This certificate is further official confirmation of the compliance of the TxCell cell therapy manufacturing facility in Besançon with the high and ever increasing standards of the pharmaceutical industry and regulators. This confirms TxCell as a leader in both the development and manufacture of economically viable personalized cellular immunotherapies in Europe.
The certificate of Good Manufacturing Practice (GMP) compliance covers the manufacture, testing, blinding activities and release of investigational biological and cell therapy products. The certificate is valid for three years. It authorizes the manufacture of phase IIb clinical batches of Ovasave, personalized cell-based immunotherapy using ovalbumin-specific regulatory T-cells (Ova-Tregs) for refractory Crohn’s disease. This clinical study is planned to start in the second half of 2014, once necessary regulatory approvals are obtained.
“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, VP Supply Chain & Qualified Person, TxCell.