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The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.
bluebird bio and apceth Biopharma GmbH announced on Dec. 15, 2016 that the companies have entered 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 multi-year manufacturing relationship and provides bluebird bio with European commercial manufacturing capabilities, including dedicated production suites within apceth Biopharma’s 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.
Source: bluebird bio