TxCell puts pilot facility in France on partial hold
All production will move to a new commercial GMP manufacturing facility by 2018
TxCell, a French biotechnology company developing personalised T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, has temporarily put its pilot manufacturing facility activities in Besançon on 'partial hold'.
The decision was made in agreement with the French regulator, Agence Nationale de Sécurité du Médicament, (ANSM).
TxCell said the move will enable the company to 'take action to ensure future compliance with Good Manufacturing Practice (GMP) for the Besançon facility'. The plant received manufacturing authorisation on 23 September 2013 (amended on 5 June 2014) as well as GMP certification on 10 June 2014.
The company said the pilot manufacturing unit in Besançon is temporary as it intends to move all production to a new commercial GMP manufacturing facility by 2018.
'The actions taken by TxCell aim at eliminating the risk of microbial contamination of released drug products,' the company said. 'At the current time, no contamination has been found in any product manufactured and released from the TxCell Besançon site.'
At the current time, no contamination has been found in any product manufactured and released from the TxCell Besançon site
Manufacturing of new products at Besançon will be on hold until compliance is ensured. TxCell should complete this by the end of the summer. The company is then expected to demonstrate GMP compliance before the end of the year.
Treatment of patients in the CATS29 study (an ongoing Phase 2b clinical trial with Ovasave to treat refractory Crohn patients) for whom at least one injection had been given, will continue, subject to the implementation of a risk analysis pre-approved by ANSM, the company said.
TxCell's CEO Stéphane Boissel commented: 'Since the decision was already made to engage a contract manufacturing organisation to enable an acceleration of recruitment in clinical trials from 2016 to 2018, this partial hold should have only potential limited impact on clinical timelines communicated in May 2015 and will not change TxCell’s development plan in the long run.
'We will work closely with ANSM 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. Importantly, no production-related safety event was reported from the beginning of the CATS29 study in December 2014.'
