bluebird bio and apceth Biopharma establish commercial drug product manufacturing agreement

apceth Biopharma will perform clinical manufacturing, process validation activities and commercial manufacturing for LentiGlobin and Lenti-D drug product.

This agreement follows a successful multi-year manufacturing relationship and provides bluebird bio with European commercial manufacturing capabilities, including dedicated production suites within apceth Biopharma’s state-of-the-art GMP facility.

Under this multi-year agreement, apceth Biopharma will perform clinical manufacturing, process validation activities and commercial manufacturing for LentiGlobin and Lenti-D drug product to support the treatment of European patients with transfusion-dependent beta thalassemia and cerebral adrenoleukodystrophy, respectively.

“At bluebird, we are committed to not only developing potentially transformative therapies, but ensuring that we can deliver them to patients. For this reason, we are committed to investing in the capabilities and infrastructure necessary to support commercialization both in the US and Europe,” said Nick Leschly, chief bluebird. “By partnering with multiple organizations, including our valued partner apceth Biopharma, we are able to develop integrated capabilities in manufacturing that can position us to effectively bring our future commercial products to patients in need.”

"We are very pleased to continue our successful contract manufacturing relationship with bluebird bio and plan to be the right partner in the future to enable product supply to European patients for clinical development and commercialization", said Christine Guenther, apceth Biopharma's CEO. "This long-term agreement confirms that apceth Biopharma is a valuable and reliable partner for our clients in the field of clinical and commercial cell and gene therapy manufacturing." Ulrike Verzetnitsch, apceth Biopharma's CTO, added: "We are very proud that our customized GMP manufacturing solutions and our deep commitment to the client's needs and expectations are recognized by bluebird bio, leading to a long-term strategic manufacturing relationship between our companies."