Takeda recognized by ISPE with 2024 Facility of the Year Awards

• Process Performance Qualification (PPQ) Shortened by 50 Percent for Takeda’s New Prefilled Syringe Filling Line in Linz, Austria, for ENTYVIO® Subcutaneous (vedolizumab)
• Recognition Illustrates Takeda’s Patient-Centric Investment in Supply Flexibility and Demonstrates Build-up of Supply Chain Resilience
• Awarded Project Sets New Standard for PPQ for New Production Lines Helping to Shorten Time to Market

OSAKA, Japan and CAMBRIDGE, Massachusetts, April 16, 2024 - Takeda (TSE:4502/NYSE:TAK) today announced that the International Society for Pharmaceutical Engineering (ISPE) has awarded the company top honors in the category Operations with the 2024 Facility of the Year Awards (FOYA). The awarded project demonstrates Takeda’s continuous patient-focused process improvements in its manufacturing operations. The project was executed at Takeda’s manufacturing site in Linz, Austria, where Takeda managed to reduce the process performance qualification (PPQ) time by 50 percent for its prefilled syringe filling line for ENTYVIO Subcutaneous (SC) formulation. With this project, the foundation is laid to reduce PPQ timelines for new production lines while further improving supply chain resilience for the organization. The shorter PPQ time increases the flexibility to supply the markets with larger quantities in a shorter period of time.

“Projects like the one at our Linz site help us to respond in a much more flexible way to patients’ needs. At the same time, it helps our entire manufacturing network apply the learnings to future projects. This award reinforces our mission and the potential for innovation that exists in pharmaceutical manufacturing,” says Thomas Wozniewski, global manufacturing and supply officer, Takeda. “We are proud to be recognized by ISPE and will continue to challenge the status quo in pharmaceutical manufacturing by embracing digitalization and Pharma 4.0 for the benefit of patients.”

The implementation of the pre-filled syringe filling line in Linz for ENTYVIO SC was run under a designated “Warp Speed” program with the aim to significantly reduce the time required to perform Process Performance Qualification (PPQ). Takeda was able to reduce the time to 24 months compared to the conventional process of approximately 36 months. The faster process required to run many preparation activities in parallel.

The PPQ is a prerequisite to verify and document that manufacturing in a new production facility is done effectively and reproducibly in accordance with approved manufacturing techniques and standards. It is a key milestone that must be reached before a new facility can be put into operation.

Pharma 4.0 technologies in the area of automation and digitalization played a key role in the execution of this project. In scope was the integration of the manufacturing execution system and the historian system over a single automation integration layer for the availability of data for electronic batch recording and external applications. A complete 3D planning model for the aseptic filling line within its future facility was also completed in order to check all requirements in the model and address challenges before the installation.

"By successfully completing the project in Linz in such a short time, we have reached a significant milestone in our endeavour to shorten strategic projects timelines at our manufacturing sites. This project was initiated under our Warp Speed program, aimed at accelerating product launches in the future. Through robust cross-functional collaboration and strong vendor partnerships, we established new standards for efficiency, speed, and success in deploying new production lines," said Gunter Baumgartner, head of global engineering, Takeda. "This achievement serves as evidence of the transformative impact on pharmaceutical manufacturing, laying the groundwork for future progress and accomplishments within our organization."

The main focus of the Takeda site in Linz is the production of biologics for the treatment of chronic inflammatory bowel diseases in various forms, including ENTYVIO. Site investments of around 100 million euros will be made until 2025 to expand the production. The awarded project is part of this investment. Once fully operational, the Linz site will fill and finish 70 percent of the global demand of ENTYVIO SC.

With a strong focus on sustainability, about 20 new freezers have been installed to store the active ingredient, shortening global supply chains. Innovative sustainable solutions are regularly evaluated and implemented along the entire value chain, such as renewable energy supply.

About the ISPE Facility of the Year Awards

Established in 2004, the Facility of the Year Awards (FOYA) recognizes 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 operations, while sharing the development of new applications of technology and cutting-edge approaches. For more information, visit ispe.org/facility-year-awards.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

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