- Massachusetts-based Bluebird bio has opened its first wholly owned manufacturing facility. Located in Durham, North Carolina, the 125,000-square-foot plant will produce clinical and commercial supplies of lentiviral vector for the company's investigational gene and cell therapies.
- The plant holds a number of manufacturing suites, as well as warehouse and quality control testing laboratories. It already employs around 50 people — including scientists, engineers, and manufacturing and operations personnel — but Bluebird expects headcount to grow to around 70 by the end of 2019.
- While the facility isn't finished, Bluebird said construction is "substantially complete" and the process of qualifying equipment is underway. The biotech first purchased the facility in November 2017, and estimates it will have spent $80 million getting the site ready for lentiviral vector production once completed.
The initial focus of the Bluebird's new plant will be creating lentiviral vector for the CAR-T cell therapies bb2121 and bb21217, which are being developed in collaboration with Celgene for the treatment of multiple myeloma.
In a statement, Bluebird said the facility could in the future expand in size and scope — potentially to manufacture its LentiGlobin gene therapy, which is in Phase 3 development for the treatment of transfusion-dependent beta-thalassemia and Phase 1/2 testing for the treatment of severe sickle cell disease.
The facility came under Bluebird's ownership in late 2017 following an $11.5 million deal with an undisclosed seller. Although it is now open, Bluebird doesn't see the plant producing any lentiviral vector until 2021, according to its most recent annual report.
Until the plant is up and running, Bluebird will continue to rely on its contract development and manufacturing partners across Europe and the U.S. Those partners are Brammer Bio, Novasep and a MilliporeSigma subsidiary.
Lonza and Apceth Biopharma also work with Bluebird on drug product for Lenti-D and LentiGlobin.
The LentiGlobin gene therapy is pending European approval, which could happen soon. As of late February, MilliporeSigma's subsidiary and Apceth were sole manufacturers of the lentiviral vectors and drug product supporting a commercial launch of LentiGlobin in Europe for transfusion-dependent beta-thalassemia.
One of Bluebird's CDMO partners, Brammer Bio, has just been acquired by Thermo Fisher Scientific for $1.7 billion, a deal principally motivated by Brammer's expertise in making viral vectors.