Minaris Regenerative Medicine, a CDMO for the cell and gene therapy industry, will be the European commercial manufacturer for Skysona (elivaldogene autotemcel, Lenti-D), a Bluebird Bio product. The European Commission has granted marketing authorisation for Skysona, which is a gene therapy for patients with Early Cerebral Adrenoleukodystrophy (CALD), a life-threatening progressive neurodegenerative disease.
“We are proud to contribute to the fight against this devastating disease in children and to support bluebird bio also with their second commercial product”, said Dusan Kosijer, CEO of Minaris Regenerative Medicine.
“Minaris is our long-standing partner for bringing gene therapies to patients in Europe,” said Andrew Obenshain, President, severe genetic diseases, Bluebird Bio. “Our collaboration will be integral as we work to provide Skysona to the community who faces the rapid and irreversible effects of CALD.”
In 2016, the companies entered into a strategic manufacturing partnership for commercial production of Zynteglo for transfusion-dependent β-thalassemia (TDT) and Skysona for CALD in Europe. In 2020, they expanded this partnership to include late stage and commercial drug product manufacturing both in Europe and the USA of LentiGlobin for the treatment of patients with sickle cell disease (SCD).
