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November 29, 2017

bluebird bio Acquires Durham, NC, Manufacturing Site for Lentiviral Vector Production

  • bluebird bio said today it has acquired a manufacturing facility in Durham, NC, from an undisclosed seller for $11.5 million, with the goal of producing lentiviral vectors for the company’s cell and gene  therapies.

    Those therapies, bluebird said, include the cerebral adrenoleukodystrophy treatment Lenti-D™, as well as LentiGlobin™ for transfusion-dependent β-thalassemia and severe sickle cell disease and multiple myeloma treatments bb2121 and bb21217.

    bluebird said the acquisition was part of a “significant” investment in manufacturing infrastructure that includes expanding in-house expertise, creating an extensive manufacturing network, and increasing manufacturing capacity.

    That investment, the company said, is timed to the advancement of several therapies into late-stage clinical development and potential commercial launch.

    “Our goal is to bring multiple therapies to market over the next four 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,” Derek Adams, Ph.D., bluebird bio’s chief manufacturing and technology officer, said in a statement.

    At the Durham facility, bluebird bio said, it will carry out an initial buildout designed to enable production of clinical and commercial supply of lentiviral vector for the company’s cell and gene therapies.

    The 125,000-square-foot facility is large enough to accommodate significant potential future expansion, including the possibility of commercial drug product production, according to bluebird bio.

    “The North Carolina manufacturing site will complement our important external manufacturing partnerships,” Adams added.

    To that end, bluebird bio has signed multiyear agreements with three manufacturing partners in the U.S. and Europe—Brammer Bio in Cambridge, MA; Novasep in Gosselies, Belgium; and MilliporeSigma, the Life Science business of Merck KGaA, in Carlsbad, CA. Each partner is collaborating with bluebird bio on production of lentiviral vector across all programs.

    bluebird bio also maintains manufacturing partnerships to produce drug product for Lenti-D and LentiGlobin with Lonza in Houston, and with apceth Biopharma in Munich, Germany.

  • Manufacturing Struggle

    bluebird bio’s announcement of the new facility comes two days after a report in The New York Times highlighted the struggle faced by gene therapy developers to secure viruses critical to the development of treatments.  According to the report, investors have become wary of companies that do not have a ready source of viruses

    “You’ve got to believe that every time someone gives a pitch to an investor, the investor will say, ‘What are you doing about manufacturing?’ ” James M. Wilson, M.D., Ph.D., director of the gene therapy program at the University of Pennsylvania, told the Times. Dr. Wilson also chairs Dimension’s Scientific and Technical Advisory Board, and serves as clinical development editor of Human Gene Therapy, a journal published by GEN publisher Mary Ann Liebert Inc.

    In Durham, bluebird bio said, the North Carolina Community College System’s custom training program will assist the company in recruiting, screening, and training employees for this facility.

    bluebird bio cited several other attractions of North Carolina to gene therapy developers, including:

    • A leading number of biologics manufacturing jobs, providing access to a highly skilled workforce;
    • The presence of top researchers at Duke University, University of North Carolina, North Carolina State University, and other universities;
    • Initiatives to develop precision health capabilities and to provide academic fellowships to help advance North Carolina’s gene therapy expertise.

    Another attraction is the state-funded North Carolina Biotechnology Center (NCBiotech)—which confirmed it will contribute funding toward Durham facility operations through NCBiotech’s Economic Development Award, created to help companies expand and grow their operations in North Carolina.

    The award is made to a local government on behalf of the company.

    “In this case, we used the award to support a smaller project that has huge potential, not only for job creation but for human health,” Robin Deacle, a spokeswoman for NCBiotech, told GEN. “NCBiotech has committed up to $100,000 to this expansion, when bluebird meets specific job creation targets. A second $100,000 award could be triggered if bluebird creates jobs to meet a higher threshold.”

    The North Carolina Community College System’s BioNetwork is also supporting bluebird bio through its Customized Training Program. BioNetwork delivers hands-on industry specific training courses in environments that mirror modern biomanufacturing plants.

    “Representatives from bluebird bio, Durham Technical Community College, and the NC Community College System will design a solution that includes assistance in recruitment and screening of potential employees, as well as the development and delivery of a training plan to ensure success of the company and the workforce,” Deacle added.

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