Bluebird Bio acquires manufacturing facility in North Carolina and executes multiple global supply agreements to enhance ability to deliver gene therapies to patients.
Bluebird Bio, Inc., a clinical-stage company developing potentially transformative gene and cell therapies for severe genetic diseases and T cell-based immunotherapies for cancer, has acquired a 125,000-square foot manufacturing facility in Durham, NC.
Once construction and validation is complete, the site will produce lentiviral vector for the company’s gene and cell therapies, including: Lenti-D for the treatment of cerebral adrenoleukodystrophy; LentiGlobin for the treatment of transfusion-dependent β-thalassemia and severe sickle cell disease; and bb2121 and bb21217 for the treatment of multiple myeloma.
In addition to the internal manufacturing capacity that the site will provide, the company also has entered into multi-year agreements with three manufacturing partners in the United States and Europe: Brammer Bio (Cambridge, MA), Novasep (Gosselies, Belgium), and MilliporeSigma, the Life Science business of Merck KGaA (Carlsbad, CA).
“The North Carolina manufacturing site will complement our important external manufacturing partnerships,” said Derek Adams, Buebird Bio chief manufacturing and technology officer. “By simultaneously establishing multiple lentiviral vector manufacturing partnerships and pursuing in-house manufacturing, bluebird is uniquely positioned to adeptly, robustly, and reliably provide our current gene and cell therapy products in development, as well as future pipeline therapies to patients in need.”
Each of the manufacturing partners is collaborating with Buebird on production of lentiviral vector across all programs. The company also partners with Lonza (Houston, TX) and Apceth Biopharma (Munich, Germany) to produce drug product for Lenti-D and LentiGlobin.
The initial North Carolina site build-out will allow for production of clinical and commercial supply of lentiviral vector, which is a critical component of the company’s gene and cell therapies. The facility is large enough to accommodate potential future expansion, including the possibility of commercial drug product production.
North Carolina is among the leaders in the U.S. in the number of biologics manufacturing jobs, providing access to a highly-skilled workforce. It also is home to top university researchers at Duke University, University of North Carolina, North Carolina State University and other universities required for such specialized operations.
The North Carolina Community College System’s custom training program will assist Bluebird in recruiting, screening, and training employees for the facility. The state’s gene therapy, rare disease, and manufacturing assets also include initiatives to develop precision health capabilities and to provide academic fellowships to help advance North Carolina’s fast-growing expertise in gene therapy.
NCBiotech, an economic development agency in the state, created the Economic Development Award to assist companies to expand and grow their operations in North Carolina. NCBiotech has committed financial resources to the expansion, when Bluebird Bio meets specific job creation targets.
(Source: Bluebird Bio, Inc.)
Filed Under: Drug Discovery