Charles River Laboratories reached a milestone in its strategic collaboration to manufacture CASGEVY (exagamglogene autotemcel [exa-cel]). CASGEVY has been 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. FDA and the Health Products Regulatory Authority, on behalf of the European Medicines Agency. The Memphis facility was the first North American contract development and manufacturing organization to be approved by the EMA to commercially manufacture an allogeneic cell therapy drug product.

SCD is an inherited blood disease that affects hemoglobin, a part of the blood that carries oxygen around the body. Vertex Pharmaceuticals collaborated with CRISPR Therapeutics to leverage the use of a gene-editing technology, known as CRISPR/Cas9, to discover and develop CASGEVY.

“Our team in Memphis is proud to receive regulatory approval to manufacture CASGEVY,” said James 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. There is a tremendous patient need for this therapy and we look forward to working with Vertex to help bring this treatment to patients.”

Charles River provides cell and gene-modified cell therapy developers with a scalable process to swiftly transition autologous and allogeneic programs to clinic and commercialization with one production partner.

In recent years, the company has broadened its cell and gene therapy portfolio with a substantial good manufacturing practice (GMP)-compliant commercial-ready capacity expansion and the integration of several strategic acquisitions to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services.