Chugai Pharma Manufacturing Co, Ltd.
Location: Fujieda City, Japan
Project: FJ3 Project
This 2026 ISPE FOYA Honorable Mention recognizes the FJ3 Project at Chugai Pharma Manufacturing’s Fujieda site, a technically distinguished achievement that advances the state of the art in small and midsize molecule API manufacturing. Completed in November 2024, FJ3 is a world-scale, multiproduct facility that uniquely delivers dual manufacturing capability for both conventional small molecules and next-generation midsize cyclic peptides within a single, integrated equipment configuration. By revisiting classical liquid-phase synthesis and establishing a proprietary Classical Solution Peptide Synthesis platform, the project overcame longstanding scaleup limitations associated with solid-phase peptide synthesis, enabling efficient production of cyclic peptides
FJ3 overcame formidable scaleup and safety challenges through modular facility design, advanced automation and digitalization, and worldclass containment systems, all while maintaining flexibility across multiple production lines. Full automation and digitalization—enabled through an integrated distributed control system, manufacturing execution system, warehouse management system, and integrated and enterprise resource planning architecture, minimizes manual handling—reduces operator burden and supports remote monitoring and future digital twin deployment. Critically, FJ3 sets a new benchmark for high-potency API safety, achieving worldclass containment performance of 0.03 μg/m³, a 40 percent improvement over the already award-winning FJ2 facility, while also incorporating seismic isolation systems designed to preserve operational continuity under Japan’s highest anticipated earthquake intensities.
Finally, this project shines as a beacon of sustainable and socially responsible manufacturing. From dramatic waste reduction enabled by proprietary synthesis methods to energy-efficient HVAC systems, green electricity usage, and low-carbon construction materials, 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. For these reasons, ISPE recognizes the Chugai FJ3 Project with a 2026 FOYA Honorable Mention recognition, shining a well-deserved spotlight on a project that exemplifies the spirit of innovation and excellence that the FOYA program was created to celebrate.
Supply Partners and Key Participants
Manufacturer/Owner Name: Chugai Pharma Manufacturing Co., Ltd.
Engineer/Architect: JGC Japan Corporation & Kajima Corporation
Commissioning, Qualifications, and Validation Services: JGC Japan Corporation
Construction Manager: JGC Japan Corporation
General Contractor: JGC Japan Corporation
Piping Subcontractor: Heiwa Fusou Techno Co., Ltd.
HVAC Subcontractor: Daidan Co., Ltd.
Automation and Control Supplier: Emerson Japan, Ltd.
Major Equipment Supplier:
- Kobelco Eco-Solutions Co. Ltd (Glass lined reactor)
- MANZEN Machinery Co, Ltd (Containment Isolator)