2026 ISPE Facility of the Year Awards (FOYA) Category Winner for Social Impact – Unmet Medical Needs | ISPE | International Society for Pharmaceutical Engineering

AstraZeneca

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.

The patient impact of this project is both profound and measurable. For patients with weeks or months to live, even a brief interruption in manufacturing can mean a lost chance at survival. By eliminating single points of failure across electrical, mechanical, automation, and process utilities, the facility protects every in-process batch as a proxy for the patient themselves. At the same time, AstraZeneca shattered the longstanding tradeoff between resiliency and sustainability by delivering a net-zero operational carbon facility, achieving 50 percent reductions in both energy and water use.

This project proves that saving lives and protecting the planet are not competing goals—but complementary ones. By applying novel design standards, cross-industry risk methodologies, and fully electrified, resource-efficient systems, AstraZeneca has delivered a replicable roadmap for sustainable, patient-first biomanufacturing at commercial scale. It is a facility that ensures uninterrupted access to lifesaving medicines while dramatically reducing environmental impact—and in doing so, it raises the bar for our entire industry.

Based on this, AstraZeneca is recognized as the 2026 ISPE FOYA Category Winner for Social Impact – Unmet Medical Needs for their Commercial Cell Therapy Facility.