Inside Chugai Pharma Manufacturing’s 2026 ISPE Facility of the Year Awards (FOYA) Project: FJ3
As pharmaceutical manufacturers work to deliver increasingly complex therapies while improving efficiency, sustainability, and worker safety, facilities must evolve to support entirely new approaches to drug production. Chugai Pharma Manufacturing’s FJ3 Project demonstrates how innovative facility design can help overcome long-standing manufacturing limitations while accelerating patient access to next-generation medicines.
Located in Fujieda City, Shizuoka, Japan, the 112,900-square-foot facility has earned Honorable Mention recognition in the 2026 FOYA program. The recognition highlights projects that may not have won a specific category but demonstrated exceptional success in overcoming significant challenges in planning, execution, and delivery.
Completed in November 2024, FJ3 was designed to strengthen Chugai’s integrated API supply network through safe, highly automated manufacturing capabilities for cyclic peptides, innovative small molecules, and macrocyclic peptides. Through its proprietary dual-production technology, modular design strategy, and scalable operations, the facility establishes a new benchmark for flexible pharmaceutical manufacturing while advancing sustainability and patient impact.
Advancing a New Era of Macrocyclic Peptide Manufacturing
The pharmaceutical industry is increasingly exploring macrocyclic peptides for their ability to target previously inaccessible disease pathways. These midsize molecules combine characteristics of both biologics and traditional small molecules, offering precise target specificity while maintaining the potential for oral delivery.
For Chugai, these capabilities are especially important as the company advances a pipeline that includes novel macrocyclic peptide therapies targeting diseases with significant unmet medical need. Some of these therapies are designed to interact with challenging intracellular and extracellular targets, including KRAS, a protein associated with tumor growth and proliferation.
Historically, however, manufacturing macrocyclic peptides at scale has been difficult. Conventional solid-phase peptide synthesis requires large quantities of reagents, specialized equipment, extensive processing steps, and presents challenges when incorporating low-reactivity, non-natural amino acids. These limitations have constrained scalability and increased manufacturing complexity.
To address these challenges, Chugai developed a proprietary manufacturing platform known as Classical Solution Peptide Synthesis (CSPS), which adapts traditional liquid-phase synthesis techniques for highly efficient peptide production.
“Conventionally, macrocyclic peptide manufacturing requires specialized equipment based on solid phase synthesis,” said Mitsuteru Kohriyama, Facility Manager of FJ3. “FJ3 demonstrates that both small- and mid-size molecules can be produced within the same equipment configuration, establishing a new benchmark for flexible and efficient facility design across the pharmaceutical industry.”
By enabling small molecules and macrocyclic peptides to be manufactured using standard equipment such as stirred-tank reactors and filter dryers, FJ3 significantly improves capital efficiency while reducing production costs and complexity.
“Grounded in a deep understanding of the structural characteristics and behavior of each amino acid, CSPS serves as a versatile peptide synthesis platform, providing a foundational technology applicable to future cyclic peptide drug development broadly,” Kohriyama added. “We believe it provides significant value to the industry to access previously unreachable therapeutic targets that have traditionally been difficult to reach with biologics or small molecules.”
Scaling Manufacturing Through Automation and Modular Design
One of the defining achievements of the FJ3 project is its ability to support highly flexible, multi-product manufacturing while maintaining operational efficiency. Rather than relying on separate production lines dedicated to different product types, the facility utilizes a single integrated equipment configuration capable of manufacturing both conventional small molecules and macrocyclic peptides. This approach enables greater capacity utilization and operational agility while supporting faster technology transfer between development and commercial manufacturing.
The project team successfully scaled complex processes involving highly potent active pharmaceutical ingredients (HPAPIs) and large quantities of flammable materials. Through extensive collaboration and engineering expertise, the facility allows a lean workforce to safely operate sophisticated manufacturing lines while reducing manual intervention.
Modularized equipment and control systems further streamline future product introduction and lifecycle management. Fully automated and digitalized operations integrate distributed control systems, manufacturing execution systems, warehouse management systems, and enterprise resource planning platforms. This digital infrastructure minimizes manual handling, reduces operator burden and human error, enables remote monitoring, and establishes a foundation for future innovations such as digital twin technologies.
Engineering Safety and Resilience into Every Aspect of the Facility
Worker protection and operational continuity were central design priorities throughout the project. FJ3 incorporates advanced containment systems capable of achieving a containment limit of 0.03 µg/m3 for highly potent APIs, representing a 40 percent improvement over Chugai’s previous award-winning FJ2 facility. The containment strategy is designed to maintain protection even in glove-failure scenarios, establishing a new benchmark for HPAPI manufacturing environments.
The project also reflects Chugai’s long history of responding to natural disasters and protecting medicine supply chains. Founded in 1925 following a devastating earthquake that exposed critical drug shortages, the company continues to place resilience at the center of its operations. Located in one of the world’s most seismically active regions, FJ3 utilizes advanced seismic isolation systems designed to protect building integrity and maintain operations during Japan’s highest anticipated earthquake intensities.
“The seismic isolation system using spherical sliding bearings adopted at FJ3 provides a compact design with increased underfloor space and optimal piping layout,” said Kohriyama. “This model will benefit pharmaceutical facilities in seismically active regions throughout the Pacific Rim to preserve building integrity and ensure operational continuity.”
Sustainability Built into Design and Operations
Beyond its manufacturing capabilities, FJ3 demonstrates how advanced pharmaceutical facilities can be designed with sustainability as a core operational principle. The project aligns closely with Chugai’s corporate sustainability commitments and the Roche Group’s safety, health, environmental, and sustainability objectives.
Among its most significant achievements is the dramatic reduction in manufacturing waste. The proprietary CSPS platform reduces waste generated per kilogram of API to less than 10 percent of that produced through conventional manufacturing methods. The facility also incorporates catalyst and organic solvent recovery systems, supporting broader industry goals for greener pharmaceutical production.
Energy efficiency was also a major consideration. FJ3’s intelligent HVAC infrastructure provides independent control across six manufacturing lines and adjusts performance based on real-time operational loads. The result is approximately 20 percent lower energy consumption and a coefficient of performance improvement from 3.9 to 4.7.
Additional sustainability features include:
- Elimination of fluorocarbon refrigerants through the use of natural refrigerants in all chillers.
- Use of green electricity across the Fujieda site.
- Incorporation of low-carbon construction materials during facility development.
- Enhanced resource recovery systems that reduce environmental impact throughout operations.
Together, these initiatives illustrate how environmental stewardship can be embedded directly into modern pharmaceutical manufacturing infrastructure.
A Future-Ready Facility with Global Impact
Situated in Shizuoka Prefecture, where tea plantations, mountains, and views of Mt. Fuji surround the Fujieda site, FJ3 reflects both Chugai’s heritage and its vision for the future. As the company celebrates its 100th anniversary in 2025, the facility embodies its longstanding commitment to innovation in service of patients worldwide.
The project’s combination of flexible manufacturing, advanced containment, seismic resilience, automation, and sustainability offers a compelling model for future pharmaceutical facilities. By enabling production of innovative macrocyclic peptide therapies at commercial scale while reducing environmental impact and protecting workers and communities, FJ3 exemplifies the kind of forward-thinking achievement recognized by the FOYA program.
As the judges noted, “FJ3 reflects a holistic approach to sustainability by design, where innovation accelerates patient impact, safety protects people and communities, and sustainability safeguards what comes next.”
About the FOYA Banquet and Awards Celebration
The 2026 FOYA Banquet and Awards Celebration will occur on Sunday, 18 October, during the 2026 ISPE Annual Meeting & Expo in Washington, D.C., USA, 18–21 October. During the event, all 2026 FOYA Category Winners will be recognized, and the Overall FOYA Winner will be announced. The prestigious black-tie celebration will feature remarks from award recipients, insights from industry leaders, and opportunities to connect with pharmaceutical engineering and manufacturing professionals from around the world.
Join the 2026 FOYA Banquet and Awards Celebration
About the ISPE Facility of the Year Awards Program
Established in 2005, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation while sharing new applications of technology and cutting-edge approaches.
