Company executing long-term strategy to develop broad manufacturing capabilities for both vector supply and drug product supply to support clinical development and commercialization across pipeline.
Bluebird bio has acquired a 125,000-sq ft manufacturing facility in Durham, North Carolina. Once construction and validation is complete, the site will produce lentiviral vectors 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.
“Our goal is to bring multiple therapies to market over the next 4 years that can transform the lives of people suffering from severe genetic diseases and cancer. Investing in a world-class manufacturing infrastructure is a crucial step in accomplishing that mission on behalf of the people who need these novel treatments,” said Derek Adams, bluebird bio chief manufacturing and technology officer.
“The North Carolina manufacturing site will complement our important external manufacturing partnerships. 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.”
The company is making a significant investment in its manufacturing infrastructure as it advances multiple products into late-stage development and potential commercial launch. Expanding in-house expertise, creating an extensive manufacturing network, and increasing manufacturing capacity ensures that bluebird can deliver on the promise of these product candidates.
In addition to the internal manufacturing capacity that this site will provide, bluebird bio also has now 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). Each of these partners is collaborating with bluebird bio on production of lentiviral vector across all programs. bluebird bio 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 significant 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 this 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 created the Economic Development Award to assist companies to expand and grow their operations in North Carolina. NCBiotech has committed financial resources to this expansion, when bluebird bio meets specific job creation targets.Read More