apceth will operate as the commercial manufacturer in Europe for ZyntegloTM, bluebird bio's gene therapy for β-thalassemia

apceth cleanroom
(PresseBox) ( Munich, Germany, )
apceth Biopharma GmbH, a leading company for the manufacturing of cell and gene therapeutics, will operate as the commercial manufacturer in Europe for ZyntegloTM, a product of bluebird bio. Yesterday the European Commission (EC) has granted conditional marketing authorisation for ZyntegloTM, a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β00 genotype, for whom haematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available.

“We are proud to be the commercial manufacturing partner of bluebird bio and to be part of bringing this life-changing therapy to TDT patients in Europe”, commented Dr Christine Guenther, CEO of apceth Biopharma. “Being one of the very few companies worldwide to manufacture a cell-based gene therapy for commercial use marks a milestone for our company.”

“We are looking forward to continue supporting bluebird bio with its other programs”, announced Dr Guenther. apceth Biopharma is bluebird bio’s clinical and commercial manufacturing partner for Europe not only for ZyntegloTM, but also for bluebird bio’s product candidate Lenti-D for cerebral adrenoleukodystrophy. Following a successful long-term manufacturing relationship, apceth Biopharma and bluebird bio entered a commercial drug product manufacturing agreement in 2016.

About Hitachi Chemical Co., Ltd.

Hitachi Chemical Co., Ltd. (TSE:4217), headquartered in Tokyo, Japan, delivers wide range of innovative products, such as electronic materials, automobile parts, energy storage devices and systems, in global markets. The company’s consolidated revenues for fiscal 2017 (ended March 31, 2018) totaled 669 billion yen (5.4 billion euros*). For more information on Hitachi Chemical, please visit the company’s website at http://www.hitachi-chem.co.jp/...

*The conversion rate is 1 euro = 124 yen.

About the Hitachi Chemical Regenerative Medicine Business Sector

The Hitachi Chemical’s Regenerative Medicine Business Sector provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. The global footprint of the business is over 180,000 square feet and includes operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama). The business leverages two decades of experience exclusively focused on the cell therapy industry.

Contact

For more information on North America services, please visit www.pctcelltherapy.com.
For more information on Europe services, please visit www.apceth.com.
For more information on Japan services, please visit www.hitachi-chem.co.jp/...
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