Minaris Regenerative Medicine GmbH, a leading contract development and manufacturing organization (CDMO) for the cell and gene therapy industry, will be the commercial manufacturer in Europe for Skysona (elivaldogene autotemcel, Lenti-D), a product of bluebird bio, Inc. The European Commission (EC) has granted marketing authorization for Skysona, the first and only 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, Minaris Regenerative Medicine GmbH.
 
Andrew Obenshain, president, severe genetic diseases, bluebird bio, said, “Minaris is our long-standing partner for bringing gene therapies to patients in Europe. 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, Minaris and bluebird bio 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, the companies expanded their manufacturing partnership to include late stage and commercial drug product manufacturing both in Europe and the USA (at Minaris Regenerative Medicine, LLC) of LentiGlobin for the treatment of patients with sickle cell disease (SCD).