The manufacturing plant will produce lentiviral vector for its gene and cell therapies, including bb2121 and bb21217 for multiple myeloma and possibly LentiGlobin for transfusion-dependent beta-thalassemia (TDT) and sickle cell disease.
bluebird bio, headquartered in Cambridge, Mass., announced it will have a ribbon-cutting ceremony at its new gene therapy factory in Durham, NC. The manufacturing plant will produce lentiviral vectors for its gene and cell therapies, including bb2121 and bb21217 for multiple myeloma and possibly LentiGlobin for transfusion-dependent beta-thalassemia (TDT) and sickle cell disease.
The company bought the plant in November 2017. Once finished, bluebird will have invested more than $80 million in the site, which has a number of manufacturing suites that can produce lentiviral vectors. It also includes a warehouse and quality control testing laboratories.
At this time, the buildings are basically complete and equipment qualification is ongoing. Initially, the factory will manufacture clinical and commercial lentiviral vector, but the plant is large enough to accommodate future expansion, including possible commercial drug manufacturing.
The plant is 125,000 square feet. The company currently employs 50 people at the location and expected to hire 20 more for that site by the end of the year.
The ceremony will be attended by North Carolina Gov. Roy Cooper, North Carolina Secretary of Commerce Tony Copeland and chief bluebird Nick Leschly.
“At bluebird bio, we view every aspect of our path to helping patients as both a privilege and a responsibility,” Leschly stated. “This includes the expertise that we’ve poured into the construction and operation of our manufacturing facility, because it is a crucial step toward our mission of bringing a new generation of treatments to people living with severe genetic diseases and cancer.”
He went on to say, “Our teams in North Carolina and across the globe are working to deliver treatments that will make a big difference for a lot of patients and families. This is what drives our ambition to bring four gene therapies forward in the next few years.”
In addition to the site in Durham, bluebird has manufacturing deals with Brammer Bio in Cambridge, Mass., Novasep in Gosselies, Belgium, and MilliporeSigma, a unit of Darmstadt, Germany’s Merck KGaA in Carlsbad, Calif. These partners are working with bluebird to produce lentiviral vector across all programs.
The company also partners with Lonza in Houston and apceth Biopharma in Munich, Germany, to manufacture products specific to Lenti-D and LentiGLobin.
At the company’s fourth-quarter and full-year 2018 report on February 21, Leschly stated, “We have an unprecedented opportunity in front of us where we anticipate that all four lead programs will have an initial filing or launch by 2022, and we are developing a deep pipeline enabled by our core technologies and our partnerships. Our first approval for LentiGlobin in TDT is anticipated this year and will be a country-by-country progressive European launch.”
Activities expected for 2019 include the European approval of LentiGlobin, filing for LentiGlobin in patients with TDT with the U.S. Food and Drug Administration (FDA) by the end of the year, the launch of a Phase III HGB-210 trial of LentiGlobin in patients with sickle cell disease by the end of 2019, the launch of KarMMa-2 and KarMMa-3 trials led by Celgene in patients with second- and third-line multiple myeloma in the first half of this year, and various data released for ongoing trials.
