AstraZeneca recognized as the 2026 ISPE FOYA Category Winner for Social Impact – Unmet Medical Needs for their Commercial Cell Therapy Facility

Location: Rockville, Maryland, USA / Project: Commercial Cell Therapy Facility

The AstraZeneca Commercial Cell Therapy Facility in Rockville, Maryland is a 105,000 square foot, three-story, fully electrified biomanufacturing facility designed to support commercial-scale autologous T-cell therapy production and late-stage oncology clinical trials. The facility is engineered to deliver therapies for up to 4,000 patients annually, with no ability to stockpile inventory due to the patient-specific nature of autologous manufacturing. To address this constraint, the project established a nonnegotiable design requirement of 100 percent operational uptime, eliminating all facility-wide maintenance shutdowns. Using quantitative risk assessments and layers of protection analysis, the design team adapted resiliency methodologies from nuclear power, oil refining, and Tier IV data centers—ultimately engineering the probability of total power loss to less than one event in 10,000 years. This performance standard establishes a new reliability benchmark for commercial cell therapy manufacturing. Continue reading here.