Lonza 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 U.S. Food and Drug Administration (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.