06.06.19
apceth Biopharma GmbH, a provider of cell and gene therapy manufacturing, 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 Christine Guenther, chief executive officer, 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.”
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.
“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 Christine Guenther, chief executive officer, 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.”
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.
