2025 ISPE FOYA Category Winner for Social Impact - Unmet Medical Needs | ISPE | International Society for Pharmaceutical Engineering

Bayer Healthcare LLC

Location: Berkeley, California, USA
Project: Cell Therapy Launch and Manufacturing Facility

Bayer’s Cell Therapy Launch and Manufacturing Facility signifies a major advancement in the production and commercialization of innovative cell therapies aimed at addressing critical unmet medical needs. This facility is one of the first of its kind for its flexible design and is Bayer's first fully electric pharmaceutical manufacturing plant. It fosters collaboration with biotech innovators, academia, and automation suppliers to expedite the development of transformative therapies

The Cell Therapy Launch Facility is designed to serve as a bridge between development and commercial manufacturing. Its purpose is to make extraordinary therapies ordinary, by addressing three areas of unmet needs - patients, platform, and capacity. First and foremost, it enables therapies to be manufactured and delivered to treat patients with unmedical needs. Second, there is an unmet industry need for a platform to develop allogeneic cell therapies. This facility's equipment provides a platform that additional allogeneic cell therapies can be developed around. Third, as the first commercial allogeneic cell therapies are in the approval process, there is an unmet need for allogeneic cell therapy manufacturing capacity, which this facility delivers.

The 100,000-square-foot facility is designed for late-stage clinical manufacturing and commercial launches of cell therapies, creating readiness for first production runs. The facility features flexible, modular space for cell culture, viral transduction, and automated filling, leveraging Bayer's expertise in regenerative medicines.

Manufacturing suites: Cleanroom spaces covering 30,000 square feet are dedicated to advancing cell therapy production, designed for NIH BMBL BSL-2 containment, providing a compliant environment for the products. The suites utilize concurrent multi-product manufacturing and viral or non-viral gene editing technologies to enhance cell functionality. They are outfitted with cutting-edge, innovatively designed and engineered equipment that guarantees unparalleled precision and efficiency

Line 4, ShapeLarge-scale automated allogeneic cell therapy process: Bayer is at the forefront of large-scale allogeneic cell therapies specifically designed to treat Parkinson's disease. The company is also pioneering cell manipulation and automated liquid handling systems, and leveraging single use materials. With customized equipment, a technologically innovative approach, and a cutting-edge process, Bayer is establishing itself as a leader in the rapidly evolving field of regenerative medicine.

Master cell bank: Created from the starting allogeneic stem cell material. The cell bank is homogeneous and thoroughly tested and characterized, enabling safe and consistent manufacturing. Bayer intends to produce large numbers of cells economically to make therapies accessible to patients. As such, Bayer plans to partner with other companies to produce allogeneic cell therapies for other regenerative medicine or oncology indications.

Significant societal impact: Bayer’s initiative represents a significant advancement in the production of allogeneic cell therapies, aimed at delivering high-quality, consistent treatments. In addition to its innovative therapeutic contributions, the facility offers opportunities that can help aspiring biotech professionals develop skills and feel empowered.

This facility is expected to significantly improve the lives of patient populations by facilitating development of innovative therapies. For example, BlueRock Therapeutics is currently differentiating stem cells into neurons, retinal photoreceptors, and cardiomyocytes. Dopamine-producing neurons could be implanted into the brain to stop or reverse Parkinsons disease, which affects over 10 million people worldwide. The facility aims to provide hope and strive for a cure for patients with unmet medical needs by making these life-changing therapies more accessible to all.

For these reasons, Bayer’s Cell Therapy Launch and Manufacturing Facility is recognized as the 2025 ISPE FOYA Category Winner for Social Impact, Unmet Medical Needs.