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|bluebird bio and apceth Biopharma Establish Commercial Drug Product Manufacturing Agreement|
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161215005065/en/
This agreement follows a successful multi-year manufacturing relationship and provides bluebird bio with European commercial manufacturing capabilities, including dedicated production suites within apceth Biopharma’s state-of-the-art GMP facility.
Under this multi-year agreement, apceth Biopharma will perform clinical manufacturing, process validation activities and commercial manufacturing for LentiGlobin and Lenti-D drug product to support the treatment of European patients with transfusion-dependent beta thalassemia and cerebral adrenoleukodystrophy, respectively.
“At bluebird, we are committed to not only developing potentially
transformative therapies, but ensuring that we can deliver them to
patients. For this reason, we are committed to investing in the
capabilities and infrastructure necessary to support commercialization
both in the U.S. and Europe,” said
"We are very pleased to continue our successful contract manufacturing
relationship with bluebird bio and plan to be the right partner in the
future to enable product supply to European patients for clinical
development and commercialization", said
About bluebird bio, Inc.
With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and cancer. bluebird bio’s gene therapy clinical programs include its Lenti-D™ product candidate, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of cerebral adrenoleukodystrophy, and its LentiGlobin™ BB305 product candidate, currently in four clinical studies for the treatment of transfusion-dependent β-thalassemia and severe sickle cell disease. bluebird bio’s oncology pipeline is built upon the company’s leadership in lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T program partnered with Celgene. bb2121 is currently being studied in a Phase 1 trial for the treatment of relapsed/refractory multiple myeloma. bluebird bio also has discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline.
bluebird bio has operations in Cambridge, Massachusetts; Seattle,
apceth Biopharma is a pioneering biopharmaceutical company with a
pipeline of cell-based gene therapeutics for the treatment of major
chronic diseases (chronic lung disease, metabolic and autoimmune
diseases) and solid cancer. The company's proprietary platform
technology is based on state-of-the-art genetic engineering of
mesenchymal stem cells. apceth Biopharma is also a successful
bluebird bio Forward-Looking Statements
This release contains “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995, including
statements regarding bluebird bio’s LentiGlobin and Lenti-D product
candidates and plans for their commercial manufacture in
Source: bluebird bio, Inc.
bluebird bio, Inc.
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Sr. Director, Investor Relations