- Lonza has signed a long-term commercial supply agreement for CASGEVY®, the first CRISPR/Cas9-based cell therapy.
- Manufacturing will take place at Lonza’s cGMP facilities in Geleen (Netherlands), with expansion plans for Portsmouth (US) by 2025.
Lonza has entered into a long-term commercial supply agreement with Vertex for the production of CASGEVY (exagamglogene autotemcel), the first cell therapy based on CRISPR/Cas9 technology. The therapy is designed as a one-time treatment for patients with transfusion-dependent beta-thalassemia or sickle cell disease.
The agreement will see Lonza provide manufacturing services through its cell therapy facilities, initially in Geleen, Netherlands, which has received Good Manufacturing Practice (GMP) certification from the U.S. FDA, EMA, and MHRA. The Portsmouth, US site is expected to become operational in 2025.
The collaboration is based on leveraging Lonza’s extensive expertise in contract manufacturing and regulatory support. Vertex aims to ensure the availability of CASGEVY® for eligible patients using Lonza’s global manufacturing network and cutting-edge technology.
Commenting on the agreement, Daniel Palmacci, President of Cell & Gene at Lonza, said, “It is a privilege to work with Vertex on bringing its innovative medicines to patients.” He also highlighted the recent regulatory approvals for the Geleen facility as a major milestone in advancing the therapy’s commercial production.
Morrey Atkinson, Ph.D., from Vertex, praised Lonza for their partnership, stating, “Manufacturing a first-of-its-kind therapy like CASGEVY® is complex and requires advanced technology and capabilities.” He emphasised the importance of the global manufacturing network to meet patient needs.
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