Breaking News

TxCell Gains GMP Certificate for Cell Therapy Mfg. Facility

June 12, 2014

Will manufacture Phase IIb batches of Ovasave for Crohn’s trial

TxCell SA has received a certificate of GMP compliance by the French National Agency for Drug Safety (ANSM) for its cell therapy manufacturing facility in Besançon, France. The GMP compliance covers the manufacture, testing, blinding activities and release of investigational biologics and cell therapy products. It also authorizes the manufacture of Phase IIb clinical batches of Ovasave, a personalized cell-based immunotherapy for refractory Crohn’s disease, which is scheduled to start in 1H14.
“This certificate of Good Manufacturing Practices compliance is a result of the outstanding work of the TxCell’s teams. We have now achieved another of our strategic objectives to be able to offer a new therapeutic option for patients without effective treatment,” said Eric Pottier, vice president of Supply Chain & Qualified Person, TxCell.

blog comments powered by Disqus
  • CMC Biologics: Growing Through Innovation

    Tim Wright, Editor||January 28, 2016
    The new chief exec talks about industry trends and growth plans.

  • Cold-Chain Logistics & The Central Lab

    Kristin Brooks, Associate Editor||January 28, 2016
    Eric Hayashi of LabConnect discusses safety measures to ensure sample integrity

  • A Look at DCAT Week ‘16

    Tim Wright, Editor||January 28, 2016
    On the pulse of the pharmaceutical manufacturing value chain, DCAT Week ‘16 will deliver top-flight education programs and networking events.