When French biotech TxCell shut down its pilot manufacturing facility in Besançon in June, it said it was a decision made with regulators but didn't lay out exactly what an inspection by France's ANSM had found. Now ANSM has filed its report, and it turns out that what it found was a lot of cases of mold contamination and a number of facility problems that probably contributed to it.
The report, filed this week on a shared EU site, says investigators found poor quality controls and 30 deviations related to mold contamination during production of investigational batches. In fact, it said 22 deficiencies were observed, 7 that rose to the status of "major deficiencies." Those included unsanitized paper batch records and labels in aseptic areas, as well as the fact that appropriate alert limits were not set for the results of microbiological monitoring of clean rooms.
TxCell, which has received an FDA fast-track designation for its Crohn's disease treatment candidate Ovasave, emphasized at the time it closed the facility that no contamination was found in products made at the facility. But ANSM noted that some of the batches were released while contamination was still under investigation.
TxCell has said it expects the Besançon site to be reapproved for production by the end of the year. In the meantime, the biotech has contracted with CMO MaSTherCell to produce its clinical batches of Ovasave. It said it is talking with the CMO about a long-term relationship. MaSTherCell is a Belgium company that was acquired in March by U.S.-based Orgenesis, which wanted to tap its cell manufacturing expertise.
- access the ANSM report here
- here's the MaSTherCell announcement
- see TxCell's financial release