apceth Biopharma GmbH will operate as the commercial manufacturer in Europe for Zynteglo™, a product of bluebird bio. The European Commission (EC) has granted conditional marketing authorization for Zynteglo™, a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available.
“We are proud to be the commercial manufacturing partner of bluebird bio and to be part of bringing this life-changing therapy to TDT patients in Europe”, said Dr. Christine Guenther, CEO of apceth Biopharma. “Being one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use marks a milestone for our company.”
“We are looking forward to continue supporting bluebird bio with its other programs”, said Dr. Guenther. apceth Biopharma is bluebird bio’s clinical and commercial manufacturing partner for Europe not only for Zynteglo™, but also for bluebird bio’s product candidate Lenti-D for cerebral adrenoleukodystrophy. Following a successful long-term manufacturing relationship, apceth Biopharma and bluebird bio entered a commercial drug product manufacturing agreement in 2016.