TxCell 'pauses' production at cell therapy pilot plant to eliminate microbial contamination risk
The French drugmaker said it ceased production in agreement with French regulator ANSM (Agence Nationale de Sécurité du Médicament) but stressed that no microbial contamination has been found in any cell therapies produced at the plant.
The Besancon site obtained manufacturing authorization in September 2013 and was certified as being in compliance with good manufacturing practice (GMP) standards in June last year.
TxCell produces personalized T cell immunotherapies for severe chronic inflammatory diseases using its ASTrIA platform, which “educates” antigen-specific regulatory cells (Ag-Tregs) from the patient’s own blood sample to target autoimmune inflammatory diseases.
Harvested white blood cells are taught to recognise disease targets, multiplied by TxCell and then reinjected into the patient.
The approach is similar to that used to make Dendreon's prostate cancer therapy Provenge.
However, unlike Dendreon which needed to extract new white cells for each batch of its product, TxCel produces many treatments from a single sample of cells.
Limited impact on trial timelines
TxCell said it expects to bring Besancon into compliance with GMP “by the end of the summer.”
TxCell’s lead product – a candidate Crohn's disease treatment called Ovasave – is currently being examined in Phase IIb study. The firm said subjects who have already received one dose of the therapy would continue to receive treatment.
CEO Stéphane Boissel said TxCell is looking for a contract manufacturing organisation (CMO) to accelerate recruitment for trials scheduled to begin next year, adding that the suspension will have only a “limited impact on clinical timelines.”
He added that: “We will work closely with ANSM, the French regulatory agency, to make sure that all potential issues at Besançon are addressed and hopefully resume to normal production activity at this site by the end of the year.”
TxCell confirmed it plans to move all production to a new commercial GMP manufacturing facility by 2018.
