Lonza & Vertex Sign a Long-Term Commercial Supply Agreement for CASGEVY
Lonza, a global manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, recently announced the signature of a long-term commercial supply agreement for CASGEVY (exagamglogene autotemcel).
CASGEVY is the first cell therapy based on the CRISPR/Cas9 technology, discoverers of which were awarded the Nobel Prize in Chemistry in 2020. CASGEVY offers the potential of a one-time treatment for eligible patients with transfusion-dependent beta-thalassemia or sickle cell disease.
Under the terms of the agreement, Vertex will leverage Lonza’s scientific, regulatory, and manufacturing expertise, global manufacturing network, and first-hand experience in the commercial manufacture of cell therapy products. Lonza will manufacture CASGEVY at the state-of-the-art cGMP cell therapy manufacturing facilities in Geleen (NL), with plans to expand to its Portsmouth (US) facility.
The Geleen (NL) cell manufacturing facility was recently granted a GMP license by the US FDA, European Medicines Agency (EMA), and Medicines and Healthcare Products Regulatory Agency (MHRA). The Portsmouth (US) site is expected to begin GMP operations in 2025.
Daniel Palmacci, President, Cell & Gene, Lonza, said “It is 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, Ph.D., 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.”
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