Lonza has signed a long-term commercial supply agreement with Vertex for Casgevy.
The cell therapy, otherwise named exagamglogene autotemcel, is the first therapy based on the CRISPR/Cas9 technology and is designed as a one-time treatment for patients with transfusion-dependent beta-thalassemia or sickle cell disease.
Through the agreement, Vertex will utilise Lonza's regulatory and manufacturing expertise, as well as its global manufacturing network.
Lonza will commercially manufacture the cell therapy product at its Geleen site in the Netherlands to begin with.
However, there are plans to expand the manufacturing capacity of Casgevy to its Portsmouth, US facility.
Lonza's Geleen cell manufacturing site was recently granted a GMP license by the FDA, EMA and MHRA, and the US site is expected to start with GMP operations in 2025.
Daniel Palmacci, President of Cell & Gene at Lonza, commented: “It's a privilege to work with Vertex on bringing its innovative and cutting-edge medicines to patients suffering from life-threatening diseases."
"We are also pleased to reach a significant milestone towards supporting the commercial manufacture of CASGEVY® by receiving the regulatory approval at our state-of-the-art cell therapy manufacturing site in Geleen.”
Morrey Atkinson, Executive Vice President and Chief Technical Operations Officer, Head of Biopharmaceutical Sciences and Manufacturing Operations, Vertex, added: “Manufacturing a first-of-its-kind therapy like CASGEVY is complex and requires advanced technology and capabilities."
"The Lonza team have been excellent partners as we have invested in our global manufacturing network to ensure CASGEVY® will be available for the patients who need it. We look forward to our continued collaboration.”
[Image credit: NHLBI]
