French Authority (ANSM) published statement of non-compliance related to mould contaminations

In June, TxCell has shut down their manufacturing facility in Besançon, but the reason was not published. The site manufactures aseptically prepared small volume liquids. The products are personalized T cellimmunotherapies using antigen specific regulatory T-cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases.

Now, the French National Agency for Medicines and Health Products Safety (ANSM) released the inspection report. The ANSM summarized the the nature of non-compliance as follows:

 "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 environemental 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 open.

2. Paper batch records 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."

TXCells is currently working on improvements of the pilot site and expects to complete the necessary activities and to get reapproved until end of 2015. In the meantime, the manufacturing of the clinical batches was outsourced to a CMO.

More details can be found in the ANSM report as well as in the TxCell press release.