Home Medizin Dies markiert einen wichtigen Meilenstein für Vertex und Charles River

Dies markiert einen wichtigen Meilenstein für Vertex und Charles River

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Charles River Laboratories International, Inc. (NYSE: CRL) announced a significant milestone in their strategic partnership for the production of CASGEVY (Exagamglogen autotemcel [exa-cel]) today. CASGEVY is approved in some countries for certain eligible patients.

The announcement follows the news that Charles River’s facility in Memphis has successfully passed consecutive audits by 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 receive approval from the EMA for the commercial production of an allogeneic cell therapy drug product.

„Our team in Memphis is proud to have received regulatory approval for the production of CASGEVY,“ said James C. Foster, Chairman, President, and Chief Executive Officer of Charles River. „We are excited to have achieved this milestone in conjunction with Vertex in the manufacture of the world’s first gene-edited therapy. There is an enormous need for this therapy among patients, and we look forward to working with Vertex to make this treatment accessible to patients.“

Use of CRISPR for SCD Treatment
SCD is an inherited blood disorder affecting millions of people worldwide. SCD impacts hemoglobin, a component of blood that carries oxygen through the body. Individuals with this condition require lifelong treatment and a significant use of healthcare resources, ultimately leading to a shortened life expectancy. Vertex collaborated with CRISPR Therapeutics to utilize gene-editing technology called CRISPR/Cas9 for the discovery and development of CASGEVY.

Cell Therapy Manufacturing Services
Charles River offers developers of cell and gene-modified cell therapies an efficient, robust, and scalable process to rapidly transition autologous and allogeneic programs into clinical and commercial production with a manufacturing partner.

In recent years, the company has significantly expanded its cell and gene therapy portfolio through substantial capacity expansion in accordance with good manufacturing practices (GMP) for commercial use and the integration of several strategic acquisitions to streamline complex supply chains and meet the growing demand for plasmid DNA, viral vector, and cell therapy services. In combination with the company’s existing testing capabilities, Charles River provides an industry-leading „Concept-to-Cure“ solution for advanced therapies.

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