For Lenti-D and LentiGlobin therapies for severe genetic diseases and T cell-based immunotherapies for cancer
Lonza Houston, a global specialist in viral gene and cell therapy manufacturing, has agreed to handle commercial manufacture of Lenti-D and LentiGlobin drug products for Bluebird Bio.
Cambridge, MA-based Bluebird Bio is a clinical-stage developer of gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer.
Lenti-D is currently in a Phase II/III study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, while LentiGlobin BB305 is currently in three clinical studies for the treatment of transfusion-dependent ß-thalassemia, and severe sickle cell disease.
This new agreement follows a successful multi-year clinical manufacturing relationship between the two firms and provides Bluebird Bio with a path to commercial supply including dedicated production suites within Lonza’s state-of-the-art facility. This 9,3000m2 facility is currently under construction in Houston, Texas, for the clinical and commercial supply of viral vectors and virally-modified cell therapy products. It is expected to come on stream in the first half of next year.
Our partnership with Lonza is one notable example of our progress on the manufacturing front
Under this multi-year agreement with Bluebird Bio, Lonza will complete the suite design, construction and validation along with process validation prior to anticipated commercial launch.
'This new strategic relationship with Bluebird Bio is an example of Lonza’s ability to be a long-term commercial partner to the cell and viral therapy industry,' said Marc Funk, COO, Lonza’s Pharma & Biotech segment.
'Our global facilities, regulatory track record and security of supply offer customers like Bluebird Bio a reliable strategic manufacturing partner for the lifetime of their therapeutic drugs.'
Nick Leschly, Chief Executive of Bluebird Bio, added: 'As we advance our gene therapy programmes through clinical trials, we are deliberately building key infrastructure and relationships in preparation for commercial launch.
He added: 'Our partnership with Lonza is one notable example of our progress on the manufacturing front, and we are pleased to benefit from their expertise and experience as we continue working to bring transformative therapies to patients in need.'