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. Today, 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 of Minaris Regenerative Medicine GmbH.
“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, 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).
About Minaris Regenerative Medicine
Minaris Regenerative Medicine is a global contract development and manufacturing organization (CDMO) for cell and gene therapies. We offer our clients high value clinical and commercial manufacturing services, development solutions, and technologies. We are pioneers in the field with more than 20 years’ experience providing outstanding quality and reliability. Our facilities in North America, Europe, and Asia allow us to supply patients worldwide with life-changing therapies. Minaris Regenerative Medicine is wholly owned by Showa Denko Materials Co., Ltd.