The German CDMO will operate as commercial manufacturer in Europe for Zynteglo, bluebird bio's first gene therapy to gain regulatory approval
Apceth Biopharma, the German manufacturer of cell and gene therapeutics, has become the commercial operator in Europe for Zynteglo, bluebird bio’s gene therapy for β-thalassemia.
Zynteglo is bluebird bio’s first gene therapy to gain regulatory approval. The European Commission (EC) granted conditional marketing authorisation for the product last Monday.
Zynteglo is 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.
Apceth CEO, Dr Christine Guenther, commented: “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.
"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.
Apceth and bluebird bio entered a commercial drug product manufacturing agreement in 2016, following a successful long-term manufacturing relationship.
Acquired by Hitachi Chemicals in April this year, apceth operates state-of-the-art manufacturing facilities with Grade B/A, C and D cleanrooms (ISO 5, ISO 7, ISO 8, BSL2) at its Munich sites.
Manufacturing production is certified according to regulatory requirements for cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs).