French National Agency for Medicines and Health Products Safety (ANSM) releases TxCell manufacturing facility inspection report
The French National Agency for Medicines and Health Products Safety (ANSM) has released the Tx cell manufacturing inspection report. Overall, 22 deficiencies were observed, including 7 major deficiencies on the following topics:
- 1. The pharmaceutical quality system was deficient as several deviations opened during the period 2014-2015 were overdue and still pending. Namely, 43 non conformities were related to environmental deviations of which 30 were related to mould contamination during production of investigational batches and Media Process Test. Moreover, some investigational product batches were released whereas deviations cases were still opened.
- 2. Paper batch record and labels required in aseptic areas were not sterilised or passed into the area by a procedure which achieves the same objective of not introducing contamination.
- 3. Appropriate alert limits were not set for the results of microbiological monitoring of clean rooms.
In June, TxCell has shut down their manufacturing facility in Besançon, but the reason was not published.ANSM now published the facility inspection report which explains the shutdown of facility. The site manufactures aseptically prepared small volume liquids. The products are personalized T cell immunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases.