TxCell claimed it would have its manufacturing operations cleaned up and back online this year after French regulators shut it down for mold contamination. The French biotech now says it has changed its mind about that. It is pretty sure it will just turn over all manufacturing to contractors, which will mean canning the more than two dozen employees that work at its facility.
TxCell said last week that it is in the midst of a "strategic review that should result in the outsourcing of all existing and future clinical and commercial manufacturing operations to contract manufacturing organizations (CMOs)." Recently named CEO Stéphane Boissel said this will allow the company just to focus on what it is good at: drug development. It is talking the situation over with the 26 employees at its pilot plant who may lose their jobs as a result of the the company's decision.
"It is our responsibility to best help the impacted Besançon staff to rapidly find new job opportunities," Raphael Flipo, TxCell's CFO, said in a statement. "The employees in Besançon, who are all very qualified and well trained, have done an excellent job since the opening of the facility in 2013. Our decision to close the Besançon facility is only driven by strategic and economic considerations."
It will instead open a "GMP-proving laboratory" someplace close to its HQ in Sophia Antipolis, France. The lab will handle process improvement and development and technology transfer to contractors. It will look for CMOs in the U.S., EU and Asia. It already has relationships with MaSTherCell in Belgium and Cell Therapy Catapult in the U.K.
TxCell shut down its pilot manufacturing facility in Besançon in June. In a report by French regulator ANSM, inspectors said they 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 cleanrooms.
In the meantime, the biotech has contracted with MaSTherCell to produce its clinical batches of Ovasave, a drug for Crohn's disease that has been fast-tracked by the FDA.
- here's the release