Thursday, July 22, 2021 Daily Archives

Catalent ploughs $100m in Italian facility to up drug substance production

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…

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…