Lonza Houston, a viral gene and cell therapy manufacturer, and bluebird bio, a clinical-stage company developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, have entered into a strategic manufacturing agreement providing for the future commercial production of bluebird bio’s Lenti-D and LentiGlobin drug products.
This agreement follows a successful multi-year clinical manufacturing relationship and provides bluebird bio with a path to commercial supply including dedicated production suites within Lonza’s state-of-the-art facility. This facility is currently under construction, for the clinical and commercial supply of viral vectors and virally-modified cell therapy products.
Under this multi-year agreement, 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. 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,” said Marc Funk, COO, Lonza’s Pharma & Biotech segment.
“As we advance our gene therapy programmes through clinical trials, we are deliberately building key infrastructure and relationships in preparation for commercial launch,” said Nick Leschly, Chief bluebird. 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.”