Charles River Laboratories reached a milestone in its strategic collaboration with Vertex to manufacture CASGEVY™ (exagamglogene autotemcel [exa-cel]). The FDA approved CASGEVY earlier this month as the first CRISPR therapy and specifically for sickle cell disease.
Charles River’s Memphis center of excellence has already passed audits from both the FDA and the Ireland-based Health Products Regulatory Authority (HPRA), on behalf of the European Medicines Agency (EMA). The Memphis facility was the first North American 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 CEO, Charles River. “We are pleased to reach this milestone working hand-in-hand with Vertex to manufacture the world’s first gene-edited therapy.”
In recent years, CRL significantly broadened its cell and gene therapy portfolio with a (GMP)-compliant commercial-ready capacity expansion and the integration of several strategic acquisitions to simplify complex supply chains and meet a growing demand for plasmid DNA, viral vector, and cell therapy services, according to Foster.
