Charles River’s Memphis Facility Approved to Manufacture Vertex’s CASGEVY™

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Charles River has achieved a significant milestone in its partnership with Vertex Pharmaceuticals to manufacture CASGEVY™ (exagamglogene autotemcel [exa-cel]) the treatment recently approved in certain countries for sickle cell disease (SCD).
Charles River Laboratories International, Inc., Charles River, has announced an important milestone in its strategic collaboration with Vertex Pharmaceuticals to manufacture CASGEVY™ (exagamglogene autotemcel [exa-cel]). CASGEVY, a groundbreaking gene-edited therapy, has received regulatory approval in certain countries, marking a crucial milestone in advancing treatment options for eligible patients.
The news is attributed to the successful completion of consecutive audits by the FDA and the Health Products Regulatory Authority (HPRA) on behalf of the European Medicines Agency (EMA) at Charles River’s Memphis facility. This facility, the first North American CDMO approved by the EMA for commercial manufacturing of an allogeneic cell therapy drug product, played a pivotal role in this strategic collaboration.
James C. Foster, Chairman, President, and CEO of Charles River, commented on the regulatory approval:
“Our team in Memphis is proud to receive regulatory approval to manufacture CASGEVY. 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.”
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CASGEVY, developed by Vertex in collaboration with CRISPR Therapeutics, utilizes CRISPR/Cas9 gene-editing technology to address sickle cell disease (SCD), an inherited blood disorder affecting millions globally. SCD affects hemoglobin, impacting oxygen transport in the blood and requires lifelong treatment.
Over the past few years, the Company has expanded its cell and gene therapy portfolio by increasing its GMP-ready capacity and acquiring strategic assets to streamline complex supply chains and meet the rising demand for plasmid DNA, viral vectors, and cell therapy services.
Source: Charles River Press Release
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