Lonza and Genetix Biotherapeutics Inc. have announced the extension of their long-term commercial manufacturing agreement for ZYNTEGLO™ (betibeglogene autotemcel), the only FDA-approved gene therapy for pediatric and adult patients with transfusion-dependent beta-thalassemia. Under the expanded agreement, Lonza will increase manufacturing capacity at its Houston (US) facility to meet growing patient demand.
Lonza and Genetix Strengthen Long-Standing Partnership
The strategic collaboration between Lonza and Genetix dates back to 2013 and was instrumental in enabling ZYNTEGLO™ commercial approval in 2022. Commercial manufacturing will continue at Lonza’s Houston site, a dedicated cell and gene therapy facility with nearly 10 years of combined clinical and commercial experience supporting this treatment. The agreement also includes provisions to scale up manufacturing for additional Genetix therapies in the future. The deal comes as Lonza continues to reshape its business following its recent completion of its pure-play CDMO transformation.
Growing Patient Demand Drives Expansion
Genetix Biotherapeutics is a privately held, commercial-stage biotechnology company dedicated to delivering genetic therapies for patients with severe rare diseases. The company holds FDA-approved therapies for sickle cell disease, beta-thalassemia, and cerebral adrenoleukodystrophy. Patient demand for Genetix therapies has grown consistently and rapidly over the past year, driving the need for expanded manufacturing capacity.
“Our extended agreement with Genetix underscores the value of our services and expertise in commercial cell and gene therapy manufacturing.”
— Daniel Palmacci, Head of Specialized Modalities, Lonza
About ZYNTEGLO™
ZYNTEGLO™ is a first-in-class, one-time ex-vivo gene addition therapy in which functional copies of a modified beta-globin gene are added into a patient’s own stem cells. This enables the production of adult hemoglobin at normal or near-normal levels, eliminating the need for regular red blood cell transfusions. The FDA previously granted orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation, and rare pediatric disease designation for betibeglogene autotemcel.
Lonza generated sales of CHF 6.5 billion with a CORE EBITDA of CHF 2.1 billion in full-year 2025. For more information, visit Lonza.
