HCATS, Apceth Expand Manufacturing Pact with Bluebird Bio

Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) and apceth Biopharma GmbH (apceth), have expanded their relationship with bluebird bio with long-term development and manufacturing services agreements for clinical and commercial supply for multiple therapies, including:

• Late stage drug product manufacturing at facilities in Germany (apceth) and the U.S. (HCATS) for bluebird bio’s LentiGlobin for the treatment of sickle cell disease (SCD) and commercial drug product manufacturing of LentiGlobin for SCD in both the U.S. and Europe
• Expanded commercial drug product manufacturing capacity in Europe for ZYNTEGLO, a one-time gene therapy for transfusion-dependent β-thalassemia (TDT)
• Expanded clinical and commercial manufacturing capacity for bluebird’s investigational Lenti-D for cerebral Adrenoleukodystrophy (CALD) in Europe

HCATS and bluebird bio entered into their first clinical services agreement in 2011. A commercial drug product manufacturing service agreement was also established between bluebird bio and apceth in 2016. In January 2020, apceth announced its readiness to begin commercial manufacturing of ZYNTEGLO with bluebird’s launch in Germany.

“With three products in our severe genetic disease franchise to potentially launch between now and 2022, securing long-term commercial drug product manufacturing capacity is critical to our ability to deliver for patients,” said Nick Leschly, chief bluebird. “Our partnership with Hitachi Chemical is a significant example of our continued progress on this front and we believe Hitachi Chemical’s recent expansion will help support our growing commercial needs. We are pleased to benefit from their expertise as well as their footprint in both the US and Europe as we work to bring transformative therapies to patients in need.