Apceth Biopharma in Gene-Therapy Manufacturing Pact
apceth Biopharma, a Munich, Germany-based mesenchymal stem-cell therapeutics company and contract development and manufacturing organization for cell and gene therapies, has formed a multi-year manufacturing agreement with bluebird bio to provide for the future European commercial production of two of bluebird bio’s gene-therapies for genetic disorders.
bluebird bio is a Cambridge, Massachusetts-based clinical-stage company developing gene therapies and T cell-based immunotherapies. Its two product candidates involved in this manufacturing agreement are Lenti-D for cerebral adrenoleukodystropy, a genetic brain disorder that most severely affects boys and men, and LentiGlobin for transfusion-dependent β-thalassemia, a severe anemia caused by a rare inherited genetic disorder.
Under this agreement, apceth Biopharma will perform clinical manufacturing, process-validation activities, and commercial manufacturing for LentiGlobin and Lenti-D drug product.
This agreement follows an earlier multi-year manufacturing relationship between the two companies and provides bluebird bio with European commercial manufacturing capabilities, including dedicated production suites within apceth Biopharma’s GMP facility.
Source: bluebird bio