Charles River, Vertex reach important milestone in cell therapy collaboration

Charles River Laboratories International announced an important milestone in their strategic collaboration to manufacture CASGEVY or exagamglogene autotemcel (exa-cel). CASGEVY is approved in some countries for certain eligible patients. The news follows Charles River’s Memphis center of excellence passing back-to-back audits from both the U.S. Food and Drug Administration FDA and the Health Products Regulatory Authority HPRA , on behalf of the European Medicines Agency EMA. The Memphis facility was the first North American contract development and manufacturing organization CDMO to be approved by the EMA to commercially manufacture an allogeneic cell therapy drug product. “Our team in Memphis is proud to receive regulatory approval to manufacture CASGEVY,” said James C. Foster, Chairman, President and Chief Executive Officer, Charles River. “We are pleased to reach this milestone working hand-in-hand with Vertex to manufacture the world’s first gene-edited therapy. There is a tremendous patient need for this therapy and we look forward to working with Vertex to help bring this treatment to patients.”