HCATS, apceth Biopharma Form Strategic Manufacturing Agreements with bluebird bio

Hitachi Chemical Advanced Therapeutics Solutions (HCATS) and apceth Biopharma (apceth), both subsidiaries of Hitachi Chemical, have expanded their relationship with bluebird bio by entering into long-term development and manufacturing services agreements for clinical and commercial supply for multiple therapies, the companies announced in a May 11, 2020 press release.

The agreements include:

• Late-stage drug product manufacturing at facilities in both Germany (apceth) and the United States (HCATS) for bluebird bio’s LentiGlobin, a gene therapy for treating sickle cell disease, and commercial drug product manufacturing for the product in both the US and Europe

• Expanded commercial drug product manufacturing capacity in Europe for Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene), a one-time gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia who do not have a β0/β0 genotype and for whom hematopoietic stem cell (HSC) transplantation is appropriate, but no human leukocyte antigen-matched related HSC donor is available

• Expanded clinical and commercial manufacturing capacity for bluebird’s investigational Lenti-D gene therapy for cerebral adrenoleukodystrophy in Europe.

These agreements are the latest in a long-standing partnership between bluebird bio and Hitachi Chemical. HCATS, which represents the North America region of Hitachi Chemical’s global regenerative medicine business, and bluebird bio entered into their first clinical services agreement in 2011. bluebird bio and apceth, which represents the Europe region of Hitachi Chemical’s global regenerative medicine business, established a commercial drug product manufacturing service agreement in 2016. In January 2020, apceth announced its readiness to begin commercial manufacturing of Zynteglo with bluebird’s announcement of the 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, in the company press release. “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.”

“We are excited to partner with bluebird bio through our new US facility, utilizing our state-of-the-art capabilities and systems for late-stage clinical testing and, ultimately, commercial production once all applicable regulatory approvals are granted,” said Robert Preti, PhD, chief strategy officer, Hitachi Chemical Life Science Business Headquarters, in the press release. “It is our honor to support bluebird bio in the manufacture of their potentially transformative gene therapies to the benefit of patients in both the United States and Europe, as the foundation for our collaboration to address this devastating disease.”

“We are very happy to deepen our trustful and productive strategic partnership with bluebird bio,” added Dr. Christine Guenther, deputy general manager of the Hitachi Chemical Regenerative Medicine Business Sector and CEO of apceth Biopharma, in the press release. “The apceth team is proud to be part of bluebird bio’s most exciting pioneering work for the advancement of cell and gene therapies and to supply patients suffering from severe genetic illnesses with potentially life-changing treatments.”

Source: apceth Biopharma