Bluebird Bio and Apceth Biopharma establish commercial drug product manufacturing agreement.
Bluebird Bio, Inc., a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, and Apceth Biopharma GmbH, a CDMO in the field of cell and gene therapy and a developer of engineered mesenchymal stem cell (MSC) therapeutics, have entered into a strategic manufacturing agreement providing for the future European commercial production of Bluebird Bio’s Lenti-D product candidate for cerebral adrenoleukodystropy and its LentiGlobin product candidate for transfusion-dependent β-thalassemia.
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,” Nick Leschly, Bluebird chief, said. “For this reason, we are committed to investing in the capabilities and infrastructure necessary to support commercialization both in the U.S. and Europe.”
Bluebird Bio, which maintains operations in Cambridge, MA; Seattle, WA; and Paris, France, has built an integrated product platform with broad potential application to severe genetic diseases and cancer. Its 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.
Apceth Biopharma is a Contract Development and Manufacturing Organization for complex cell and gene therapy products. Based in Munich, Germany, the company provides expertise and state-of-the-art GMP facilities to clients from around the world. The privately owned biopharmaceutical company has a pipeline of cell-based gene therapeutics for the treatment of major chronic diseasesand solid cancer. Its proprietary platform technology is based on genetic engineering of mesenchymal stem cells.
(Source: Business Wire)