bluebird bio Opens State-of-the-Art Gene and Cell Therapy Manufacturing Facility in Durham, North Carolina
Business Wire 22-Mar-2019 8:00 AM
Gov. Cooper to cut ribbon on facility that will strengthen bluebird
bio's capabilities to manufacture products for clinical development and
commercial supply
bluebird bio, Inc. (NASDAQ:BLUE) today announced the official opening
of its first wholly owned manufacturing facility in Durham, N.C., that
will produce lentiviral vector for the company's investigational gene
and cell therapies, including: bb2121 and bb21217 for the treatment of
multiple myeloma and potentially LentiGlobin™ for the treatment of
transfusion-dependent ß-thalassemia (TDT) and sickle cell disease.
Gov. Roy Cooper, Secretary of Commerce Tony Copeland and local patient
advocates will join chief bluebird Nick Leschly in a ribbon cutting
ceremony at the 125,000-square-foot facility. Currently, bluebird
employs approximately 50 scientists, engineers, manufacturing and
operations personnel at the facility and is on track to grow to
approximately 70 employees by the end of 2019.
"At bluebird bio, we view every aspect of our path to helping patients
as both a privilege and a responsibility. 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," said Leschly. "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."
"North Carolina is proud to bring bluebird bio's cutting-edge work to
Durham," Governor Cooper said. "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."
bluebird bio purchased the facility in November 2017. Once completed,
the company will have invested more than $80 million building a world
class site equipped with multiple manufacturing suites capable of
producing lentiviral vector (LVV). The facility also includes warehouse
and quality control testing laboratories. The facility construction is
substantially complete and equipment qualification is underway.
Initially, bluebird bio expects the facility to produce clinical and
commercial supply of lentiviral vector, which is 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 goal of gene therapy is to change or replace faulty genes with
functional ones 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. Prior to gene therapy treatment, copies of functional genes are
added to a vector — the delivery system — in a laboratory setting. The
vector, with copies of the functional gene, is added to blood stem cells
collected from the patient. The cells that now have functional copies of
the gene are referred to as gene-modified cells.
In addition to the Durham facility, bluebird bio also has multi-year
agreements with three manufacturing partners in the United States and
Europe: Brammer Bio (Cambridge, Mass.), Novasep (Gosselies, Belgium) and
MilliporeSigma, the Life Science business of Merck KGaA (Carlsbad,
Calif.). Each of these partners is collaborating with bluebird bio on
production of lentiviral vector across all programs. bluebird bio also
partners with Lonza (Houston, Texas) and apceth Biopharma (Munich,
Germany) to produce drug product for Lenti-D and LentiGlobin.
bluebird will receive an Economic Development Award from NCBiotech upon
meeting job creation targets in North Carolina and will also receive
life-sciences-specific employee training support through the North
Carolina Community College System's Customized Training Program.
About bluebird bio, Inc.
bluebird bio is pioneering gene therapy with purpose. From our
Cambridge, Mass., headquarters, we're developing gene therapies for
severe genetic diseases and cancer, with the goal that people facing
potentially fatal conditions with limited treatment options can live
their lives fully. Beyond our labs, we're working to positively disrupt
the healthcare system to create access, transparency and education so
that gene therapy can become available to all those who can benefit.
bluebird bio is a human company powered by human stories. We're putting
our care and expertise to work across a spectrum of disorders by
researching cerebral adrenoleukodystrophy, sickle cell disease,
transfusion-dependent ß-thalassemia and multiple myeloma using three
gene therapy technologies: gene addition, cell therapy and
(megaTAL-enabled) gene editing.
bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and
Zug, Switzerland. For more information, visit bluebirdbio.com.
Follow bluebird bio on social media: @bluebirdbio,
LinkedIn,
Instagram
and YouTube.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995, including
statements regarding the construction and manufacturing capacity of the
Company's facility, and the advancement of, and anticipated development
and commercialization plans for, the Company's product candidates. Any
forward-looking statements are based on management's current
expectations of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially and
adversely from those set forth in or implied by such forward-looking
statements. These risks and uncertainties include, but are not limited
to, the risk that the manufacturing facility will not be completed and
qualified to manufacture lentiviral vector or drug product on the
timelines we anticipate or at all; the risk that we are unable to
successfully operate a manufacturing facility for clinical or commercial
supply; the risks that the preliminary positive efficacy and safety
results from our prior and ongoing clinical trials of our product
candidates will not continue or be repeated in our ongoing or planned
clinical trials; risks that the current or planned clinical trials of
our product candidates will be insufficient to support future regulatory
submissions or to support marketing approval in the U.S. and EU; and the
risk that our product candidates will not be successfully developed,
approved or commercialized. For a discussion of other risks and
uncertainties, and other important factors, any of which could cause our
actual results to differ from those contained in the forward-looking
statements, see the section entitled "Risk Factors" in our most recent
Form 10-K as well as discussions of potential risks, uncertainties and
other important factors in our subsequent filings with the Securities
and Exchange Commission. All information in this press release is as of
the date of the release, and bluebird bio undertakes no duty to update
this information unless required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190322005069/en/
