Spotlight On... France's ANSM orders French biotech Theravectys to suspend manufacturing; Potential buyer for Ranbaxy plant in Ireland drops out; India's Alkem says FDA signs off on a plant; and more...

Another French biotech has had its clinical supply manufacturing shut down by French drug regulator ANSM after inspectors found a number of serious problems. According to a recent report posted by the European Medicines Agency, ANSM inspectors in November took a look at Theravectys in Villejuif, France, a biotech which is producing lentiviral vectors for clinical development and doing cell work for chimeric antigen receptors (CARs) and T-cell receptor (TCR)-based cell therapies. The facility was only approved in April of last year. During the inspection, they found 45 deficiencies, 5 of which they deemed critical and 17 major. They included testing media fill with "unqualified equipment." Last year, regulators recommended the same action against TxCell, a French biotech working on T-cell treatments for chronic inflammatory and autoimmune diseases. TxCell has since transferred its manufacturing to a contractor. Access the EMA report here | More

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