Meet the 2023 FOYA Innovation Category Winner: Chugai Pharma Manufacturing Co., Ltd.
Facility of the Year Award (FOYA) Winners in the Innovation category exemplify the application of novel manufacturing processes, innovative design concepts, new technologies, and unique solutions that exemplify the next generation of agile, flexible, efficient, and effective new as well as existing pharmaceutical and biotechnology facilities. This includes implementation of commercially available and custom developed equipment yielding superior results, improved competitive position, and/or demonstrated imaginative collaboration with vendors/suppliers/manufacturers, all while maintaining and meeting stringent safety standards.
Chugai Pharmaceutical Co. Ltd. was founded in 1925. In the 1980s, in addition to small molecule drug discovery, Chugai began to engage in biotechnological drug discovery. In 2005, it launched the first antibody drug produced in Japan. In 2002, it entered into a strategic alliance with Roche and became a member of the Roche Group, which currently holds the top share of the antibody drug market in Japan, challenging mid-size molecule drugs as a third modality. Chugai Pharma Manufacturing Co., Ltd, the awardee for Innovation, was founded in 2006.
FJ2 Project – Shizuoka Pref., Japan
Breaking New Ground – Beyond the “Wall of 0.05µg/m3”
Chugai Pharmaceutical Building 48, known as FJ2, is an active pharmaceutical ingredient (API) facility for the manufacture of small and mid-size molecule drugs to be used for clinical development purposes. The Chugai group of companies recently focusing on mid-size molecule discovery.FJ2 will enable Chugai to establish its own stable supply chain for APIs that are difficult to manufacture on a large scale, including high potency APIs, from early clinical development through to market launch. FJ2 consists of three production lines: "Line A" for the production of mid-size molecule APIs such as peptides, "Line B" for the production of small-molecule synthetic APIs, and the "Common Line". All Lines are fully compliant with global GMPs and are capable of manufacturing high potency pharmaceutical ingredients, which had been difficult to do.
Why Chugai Won
World-Class Containment Facility: Attaining OEL=0.05μg/m3 is an extremely high containment performance, and FJ2 aimed to exceed this containment performance value. Operational details were clearly defined starting from the basic design phase, selection of the optimum containment equipment through assessment activities, verification of the containment performance using prototypes, and refining of the design by the use of mock-ups. It was verified through post-installation commissioning that the resulting fabricated equipment achieved the expected containment performance.
Multi-Purpose Mid-Size Molecule API Facility
The solid-phase synthesizer is among the largest in Japan. Process development engineers and equipment design engineers worked together in exploring approaches to validating the solid-phase synthesizer to achieve scale-up production. Parameters affecting the flow conditions in the synthesizer were evaluated, and the equipment design was developed. To improve quality, the engineers proceeded with the equipment design by means of confirmation using a 3D model. They were able to complete the complex process operations in an automated manner using a process control system (PCS).
Advanced Cleanability
In developing the project and designing the required equipment, the team reaffirmed that avoidance of product cross-contamination was most important. From the basic design phase, a design target value, so-called “DEL”, for occupational exposure limit (OEL) was set based on the expected toxicity of the high potency active substances. As there is no perfect equipment for achieving the required design target values for all process operations, the containment needs were identified along with work to be performed. A study was conducted during the design phase to identify containment functions by an optimum balance of hardware and software. Since meeting cleaning criteria between batches for high potency APIs is extremely difficult, equipment selected for FJ2 has improved cleanability. CIP cleaning tanks are glass-lined and have long nozzles. Spray rings are installed enabling cleaning solution to be injected into the nozzles for pinpoint delivery of cleaning solution even into hard-to-clean areas.
Environmentally Friendly
Chugai Pharmaceutical’s overall environmental goals were prioritized when designing the facility. To avoid the use of CFCs and CFC materials, which deplete the ozone and contribute to global warming, natural refrigerants were used for process chillers and HVAC chillers. CFC-free and CFC alternatives-free equipment was actively adopted. The energy-saving design of the facility was verified through Chugai’s dedicated assessment activities.
Paradigm Shift in Project Implementation
Chugai was committed to "making the Project a project where everyone working on it is happy to be working on it." To that end, members introduced High-Performance Projects™, activities that brought Chugai employees, construction company employees, and the suppliers/fabricators together to ensure all were aligned and involved in moving the project in one direction.
Want to Learn More?
Attend the 2023 Facility of the Year Awards Celebratory Reception and Banquet on 15 October at Mandalay Bay Resort in Las Vegas, Nevada, USA held in conjunction with the 2023 ISPE Annual Meeting & Expo.
Nominate Your Facility for the 2024 Foya Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2024 FOYA program winner. Applications must be submitted by 4 December 2023.
