Tuesday, December 19, 2023
Charles River Laboratories International, Inc. (NYSE: CRL) has reached a significant milestone in its collaboration with Vertex Pharmaceuticals by obtaining regulatory approval for the production of CASGEVY™ (exagamglogene autotemcel [exa-cel]). CASGEVY has been approved in certain countries for eligible patients. This accomplishment comes after the Memphis center of excellence, operated by Charles River, successfully passed 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).
Being the first North American contract development and manufacturing organization (CDMO) approved by the EMA, the Memphis facility is now authorized to commercially manufacture an allogeneic cell therapy drug product.
James C. Foster, Chairman, President, and Chief Executive Officer of Charles River, expressed pride in the Memphis team for obtaining regulatory approval for CASGEVY. He highlighted the collaboration with Vertex in manufacturing the world's first gene-edited therapy and emphasized the substantial patient need for this innovative treatment.
CASGEVY, developed in collaboration with CRISPR Therapeutics, utilizes the CRISPR/Cas9 gene-editing technology to address sickle cell disease (SCD), an inherited blood disorder affecting millions worldwide. SCD impacts hemoglobin, crucial for oxygen transport in the blood, requiring lifelong treatment and significant healthcare resources.
Charles River, specializing in cell and gene-modified cell therapy, offers developers an efficient, robust, and scalable process for transitioning autologous and allogeneic programs to clinic and commercialization. The company has expanded its cell and gene therapy portfolio, enhancing good manufacturing practice (GMP)-compliant commercial-ready capacity and integrating strategic acquisitions. This expansion aims to simplify supply chains and meet the increasing demand for plasmid DNA, viral vectors, and cell therapy services. Charles River's comprehensive capabilities enable the provision of an industry-leading "concept-to-cure" solution for advanced therapies.
Source: businesswire.com
