TxCell puts partial hold on manufacturing in agreement with French regulator
French biotech company TxCell (Euronext Paris: TXCL) has temporarily put its pilot manufacturing facility activities at Besançon in France on partial hold, in agreement with the French regulator.
The actions aim particularly at eliminating the risk of microbial contamination of released drug products, though no contamination has been found in any product manufactured and released from the site.
TxCell has taken the decision in order to ensure future compliance with Good Manufacturing Practice (GMP) at the facility. The Besançon site obtained manufacturing authorization on September 23, 2013, and GMP certification on June 10, 2014. The pilot manufacturing unit in Besançon is temporary and TxCell intends to move all production to a new commercial GMP facility in 2018.
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