The French firm temporarily suspended production at its pilot plant in Besancon this week to eliminate the potential risk that cell therapies made at the site become contaminated by microbes.
COO Miguel Forte told us TxCell took the precautionary action after French regulator ANSM (Agence Nationale de Sécurité du Médicament) told it environmental monitoring could be improved.
“Even though no product contamination was identified it was agreed with ANSM to interrupt the production of on-going manufacturing batches and not proceed with new product releases” Forte said, adding that TxCell had been allowed to ship existing product to patients in an ongoing trial.
TxCell has initiated enhanced training for operators and introduced more stringent material sterilisation measures in manufacturing areas according to Forte, who said “more resources are being dedicated to manage the quality system, document and monitoring activities.”
The Besancon site had been the only site supplying TxCell’s candidate Crohn’s Disease therapy, Ovasave, to patients in a clinical trial.
However, according to Forte, the firm was already looking for a contractor to increase production capacity before the stoppage in a bid to accelerate patient recruitment.
“We are currently in the process of selection the CMO from a small number of cellular therapy-specialised contract manufacturing organisations” he said.
“In view of the partial hold of our Besançon site we have accelerated that selection process in order to have the CMO ready to start manufacturing as early as possible, sometime in early 2016, and compensate for the potential delay.”
TxCell also plans to set up a larger manufacturing facility to support Phase III trials Forte said, explaining that the firm “is currently engaging with different potential partners to finalise the project of this site in France.”