DURHAM – bluebird bio, a Massachusetts-based gene and cell therapy company, has opened its first wholly owned manufacturing facility in Durham amid cheers from state leaders.

Bluebird Bio logo

“North Carolina is proud to bring bluebird bio’s cutting-edge work to Durham,” said North Carolina Gov. Roy Cooper. “bluebird is developing treatments for devastating diseases that could change the course of medicine. And, with the Triangle’s highly-skilled workforce, it will continue to be a leader in the biotech field.”

Cooper was joined by Secretary of Commerce Tony Copeland, bluebird executives, patient advocates and others at a March 22 ribbon-cutting ceremony at the facility, located at 1733 T.W. Alexander Drive.

The facility is “a crucial step toward our mission of bringing a new generation of treatments to people living with severe genetic diseases and cancer,” said Nick Leschly, bluebird’s president and chief executive officer. “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.”

The 125,000-square-foot facility will produce lentiviral vector for the company’s investigational gene and cell therapies, including treatments for multiple myeloma, transfusion-dependent β-thalassemia and sickle cell disease.

bluebird purchased the facility in November 2017 and has been refitting it with production suites, quality control testing laboratories and warehousing space.

Construction is substantially complete, and equipment qualification is under way. The company said it will have invested more than $80 million in the facility once it’s completed.

“Chief bluebird” Nick Leschly at the Durham campus opening. NC Department of Commerce photo

bluebird employs about 50 scientists, engineers, manufacturing and operations personnel in Durham and said it would have about 70 employees there by the end of this year.

The company will receive an Economic Development Award from the North Carolina Biotechnology Center upon meeting job-creation targets in North Carolina and will also receive life-sciences-specific employee training support through the N.C. Community College System’s Customized Training Program.

Initially, the Durham plant will produce clinical and commercial supplies of lentiviral vector, a critical component of the company’s gene and cell therapies. The facility is large enough to accommodate “significant future expansion,” including the possibility of manufacturing commercial drug product, the company said.

bluebird bio’s gene therapy treatment for blood disorder advances

In addition to the Durham facility, bluebird bio also has multi-year agreements with three manufacturing partners in the United States and Europe for the production of lentiviral vectors: Brammer Bio of Cambridge, Mass., Novasep of Gosselies, Belgium, and MilliporeSigma, the life science business of Merck, in Carlsbad, Calif.

bluebird also has partnerships with Lonza of Houston and apceth Biopharma of Munich to produce drug product for Lenti-D, its treatment for cerebral adrenoleukodystrophy, and LentiGlobin, its treatment for transfusion-dependent β-thalassemia and severe sickle cell disease. Both drug candidates are in late-stage clinical trials.

The goal of gene therapy is to change or replace faulty genes with functional genes in order to prevent, treat or cure a disease. Vectors are selected parts of viruses that have been genetically modified so they can deliver new genes into cells without causing an infectious disease.

bluebird is working on a spectrum of disorders using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

The company is headquartered in Cambridge, Mass., and has facilities in Durham, Seattle and Zug, Switzerland.

Bluebird’s stock shares are traded on the NASDAQ market under the ticker symbol BLUE.

(C) N.C. Biotech Center

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