DURHAM – Potential therapies for several rare diseases and cancers will be manufactured in Durham, according to Cambridge, Mass.-based bluebird bio, which has purchased a 125,000-square foot manufacturing site.

bluebird (Nasdaq: BLUE) is a clinical-stage company committed to developing potentially transformative gene and cell therapies for severe genetic diseases and T cell-based immunotherapies for cancer. Once construction and validation is complete, the site will produce lentiviral vector for the company’s gene and cell therapies, including:

  • Lenti-D to treat cerebral adrenoleukodystrophy;
  • LentiGlobin to treat transfusion-dependent β-thalassemia and severe sickle cell disease; and
  • bb2121 and bb21217 to treat multiple myeloma.

“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,” said Derek Adams, bluebird bio chief manufacturing and technology officer.

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

bluebird joins an emerging cluster of gene editing, gene therapy and rare disease researchers and companies in the Research Triangle region. About one of every nine federal research dollars for rare diseases flows through North Carolina universities.

“As gene therapy has become a reality, it’s energizing to see a company like bluebird bio and its therapies with the potential to transform patient care,” said William O. Bullock, MBA, senior vice president, economic development and statewide operations for NCBiotech.

“It’s significant that these revolutionary therapies will be produced right here in North Carolina.”

Developing talent for the future

bluebird bio product pipeline

In addition to scientific assets, North Carolina is home to the largest U.S. workforce of vaccine manufacturing talent. The North Carolina Community College System’s BioNetwork will support the extension of those capabilities for bluebird bio through the Customized Training Program.

“Representatives from bluebird bio, Durham Technical Community College, and the N.C. Community College System will design a comprehensive solution that includes assistance in the 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. We look forward to this project with bluebird,” said Maureen Little, vice president, economic development, North Carolina Community College System

This project also received financial support from NCBiotech’s Economic Development Award program. EDAs assist companies in expanding and growing their operations in North Carolina. NCBiotech has committed up to $100,000 to this expansion, when bluebird meets specific job creation targets.

Long-term manufacturing planning

Bluebird’s 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 can accommodate significant potential future expansion, including possible commercial drug product production.

The company says it is making a significant investment in its manufacturing infrastructure as it advances multiple products into late-stage development and potential commercial launch.

In addition to the internal manufacturing capacity that this site will provide, bluebird bio also has entered into multi-year agreements with three manufacturing partners in the United States and Europe.

Gene therapy in North Carolina

North Carolina’s home-grown gene therapy cluster is fueled by G1 Therapeutics, Locus Biosciences, and Precision Biosciences. Each uses a different method to attack infections, disease and/or cancer at its source – the genetic code of an organism.

Each of the companies has received significant funding in the last year, including G1’s $105 million IPO, Locus’ $19 million funding round and Precision’s $1.6 billion deal with Baxalta. NCBiotech also provided early funding support to G1 and Locus.

Following Pfizer’s acquisition of Chapel Hill gene therapy company Bamboo Therapeutics, the company worked with NCBiotech to develop a transformative $4 million post-doctoral fellowship program in gene therapy.

(C) N.C. Biotech Center