ᐈ Major Milestone: Charles River & Vertex Revolutionize Cell Therapy Manufacturing

📅 December 18, 2023: Charles River Laboratories has achieved a milestone in its collaboration with Vertex to manufacture CASGEVY, the first CRISPR therapy approved by the FDA for sickle cell disease. Charles River’s Memphis facility is the first North American CDMO approved by the EMA to commercially manufacture an allogeneic cell therapy drug product. The CEO of Charles River expressed pride in reaching this milestone and working with Vertex. Charles River has been expanding its cell and gene therapy portfolio to meet growing demand.

📢 Charles River Hits Milestone in Cell Therapy Manufacturing: FDA-Approved CRISPR for Sickle Cell

Introduction:

Charles River Laboratories, a leading contract research organization, has achieved a milestone in its collaboration with Vertex Pharmaceuticals to manufacture CASGEVY™, the first CRISPR therapy approved by the FDA for sickle cell disease. Charles River’s Memphis facility, which is approved by the European Medicines Agency, will be responsible for commercial manufacturing of the allogeneic cell therapy drug product.

Main points:

Charles River Laboratories has reached a milestone in its collaboration with Vertex to manufacture CASGEVY, the first CRISPR therapy approved by the FDA for sickle cell disease.
The Memphis facility of Charles River Laboratories has received approval from both the FDA and the Ireland-based Health Products Regulatory Authority to commercially produce allogeneic cell therapy drug products.
The Memphis facility is the first North American contract development and manufacturing organization to be approved by the European Medicines Agency for commercial manufacturing.
The achievement of this milestone demonstrates Charles River’s commitment to expanding its cell and gene therapy portfolio and meeting the growing demand for these services.
The collaboration between Charles River and Vertex aims to manufacture the world’s first gene-edited therapy.

Conclusion:

Charles River Laboratories has achieved a significant milestone in its collaboration with Vertex Pharmaceuticals to manufacture CASGEVY, the first CRISPR therapy for sickle cell disease. The approval of the Memphis facility by regulatory authorities demonstrates Charles River’s expertise in cell therapy manufacturing. This achievement further strengthens Charles River’s position in the growing field of cell and gene therapy and highlights the increasing demand for these innovative treatments.