apceth Biopharma joins Lonza as bluebird bio cell therapy contractor
apceth spokeswoman Suncana Kern told us: "The production of the bluebird bio products will take place in our GMP-certified production facility with multiple cleanroom suites, which is located in Ottobrunn near Munich."
She added that the firm will supply LentiGlobin and Lenti-D for clinical trials and, if they go on to be approved, for commercial launch.
"The project staff as well as the production start date are both dependent on the specific needs of bluebird bio as a customer. This includes primarily bluebird bio clinical trial and licensing strategy with the two gene therapy products, as well as the speed and intensity of the patient recruitment within the European clinical trials."
The German contractor is the second firm bluebird has hired to make the two products this year.
In June it hired Swiss life sciences supplier Lonza to produce the two therapies at the cell and gene therapy plant Lonza is building in Pearland, Texas.
Kern told us "the two bluebird bio manufacturing agreements, the one of apceth Biopharma and the one of Lonza, are separate."
LentiGlobin is an autologous gene therapy being developed for people with transfusion-dependent beta-thalassemia (TDT) and severe sickle cell disease.
It works by inserting a functional beta-globin gene into a patient’s own hematopoietic stem cells ex vivo.
The product was accepted for expedited review by the European Medicines Agency (EMA) in September.
Lenti-D, also an autologous gene therapy candidate, is being developed to stabilise or prevent progression of cerebral adrenoleukodystrophy (ALD).