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).
