Bayer, Astellas Open Cell, Gene-Therapy Mfg Facilities

Astellas Pharma and Bayer’s subsidiary, BlueRock Therapeutics, a New York-based developer of cell therapies, have announced separate expansions in cell- and gene-therapy manufacturing.

Astellas Pharma has opened a new late-stage clinical and commercial gene-therapy manufacturing facility in Sanford, North Carolina. The 135,000-square-foot stand-alone facility provides clinical- and commercial-scale manufacturing for Astellas’ pipeline of adeno-associated virus (AAV) gene therapies. The company’s $100-million investment will also support global supply chain needs and in-house quality control testing and is expected to create more than 200 jobs through 2026.

Separately, Bayer’s BlueRock Therapeutics has established a new site for cell therapy innovation on Bayer’s campus in Berlin, Germany. A multidisciplinary BlueRock team will be set up during 2022 to provide clinical development and operational support for Europe, including activities for chemistry, manufacturing and controls (CMC). The move enables the expansion and acceleration of BlueRock’s clinical trials to Europe. BlueRock recently closed enrollment for a Phase I clinical trial for BRT-DA01, its cell therapy for treating Parkinson’s disease and intends to initiate a global study in the second half of 2022. With the establishment of its new site in Berlin, BlueRock broadens its geographical footprint, which includes the US, Canada, and now Europe.

Source: Bayer, BlueRock Therapeutics, and Astellas