Catalent will add biologics drug substance production capabilities to its Italian plant, which it says will support demand from the European market. The $100 million investment will see contract development manufacturing organization (CDMO) Catalent install two 2,000 L single-use bioreactors in newly constructed manufacturing suites at its Anagni, Italy facility it acquired from Bristol Myers Squibb in June 2019. Additionally, the firm will build infrastructure required to house a further six 2,000 L single-use bioreactors and the first phase of…
Thursday, July 22, 2021 Daily Archives
Second Bluebird gene therapy approval a boon for Minaris
CDMO Minaris says it will be the commercial manufacturer for Skysona (elivaldogene autotemcel, Lenti-D), a second Bluebird Bio gene therapy approved by the European Commission. The European Commission (EC) granted marketing authorization of Skysona for the treatment of early cerebral adrenoleukodystrophy (CALD) yesterday. The one-time gene therapy uses a patient’s own hematopoietic stem cells (HSC) to treat the underlying cause of the neurologic condition CALD. SKYSONA uses ex vivo transduction with the Lenti-D lentiviral vector (LVV) to add functional copies…