Germany’s Apceth Biopharma, a CDMO focused on cell and gene therapeutics, has won the contract to produce Bluebird Bio’s recently EU-approved Zynteglo.
The European Commission granted conditional marketing authorization Monday for Zynteglo, which is a gene therapy designed to treat transfusion-dependent β-thalassemia (TDT).
Zynteglo adds functional copies of an altered form of the β-globin gene into TDT patients’ own blood stem cells. The inserted genes then produce hemoglobin at normal levels, reducing or eliminating the need for the frequent blood transfusions that TDT patients generally receive.
“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,” Christine Guenther, M.D., Apceth’s chief excecutive, said in a statement. “Being one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use marks a milestone for our company.”
Bluebird has said it expects to file for FDA approval of Zynteglo by the end of the year.
In April, Hitachi Chemical completed its $86.8 million acquisition of Apceth in a deal that gave the Japanese conglomerate two manufacturing sites in Munich with 6,458 square feet of cleanroom space.