2024 ISPE FOYA Category Winner for Operations – Facility Fit; Takeda Austria GmbH

A Legacy of Excellence

The manufacturing site in Linz, Austria began in the late 1960s as a small molecule production site. Over the years, it has evolved into a pivotal manufacturing hub for Takeda’s oncology and biologics products. This evolution is a testament to Takeda’s dedication to innovation and excellence in pharmaceutical manufacturing.

The beePFS Project: A Revolutionary Venture

The team at the Linz site embarked on the beePFS project, a groundbreaking initiative within Takeda's Super-Fast Track WARP Speed program. This project aimed to revolutionize the process performance qualification (PPQ) timeline and enhance supply chain resilience through a strategic dual-source approach. Despite the global COVID-19 pandemic and supply chain disruptions, the beePFS project achieved unprecedented success by completing the project 50 percent faster than standard projects previously undertaken by Takeda and within the industry for similar scope.

Key Factors Contributing to Success

Several factors which are outlined below contributed to the accelerated timeline and success of the beePFS project, highlighting Takeda's commitment to excellence through the WARP Speed program.

Super-Fast Track Execution:

The beePFS project, as part of Takeda's Super-Fast Track WARP Speed program, achieved the completion of all PPQ runs within a 24-month timeline. This remarkable achievement, despite the pandemic and supply chain challenges, showcases the project team's dedication to rapid execution.

Innovative Technologies:

Takeda implemented innovative technologies such as augmented reality (AR) training and the seamless integration of pre-use, post-sterilization integrity testing (PUPSIT), a key part of the Annex 1 regulation framework for sterile production. AR training provided a realistic, risk-free environment for learners, while PUPSIT integration ensured swift reaction times for sterile filter integrity tests. The Austrian AGES authority's approval further validates beePFS's commitment to quality and regulatory excellence.

Transformational Impact and Facility Modernization:

The introduction of prefilled syringe filling at the Linz facility has strengthened Takeda’s supply chain resilience. The co-location of drug product activities optimized supply chains and enhanced operational efficiency. Modernization efforts, including 3D planning and the incorporation of isolators, showcase beePFS's commitment to maximizing efficiency. Innovative solutions, such as a vertical conveyor, addressed challenges and laid the foundation for a secure future within Takeda’s manufacturing network.

Elevating Operational Excellence:

Throughout the beePFS project, there was a dedicated focus on process refinement and automation. Collaborative efforts with suppliers enhanced value addition within the process, extending beyond the project’s scope. Meticulous visual inspection capabilities ensured rigorous quality control measures, positioning beePFS as a cornerstone in Takeda’s pursuit of operational excellence.

Embracing Digitalization and Pharma 4.0:

The integration of the manufacturing execution system (MES) and historian system, coupled with high-level automation and the establishment of a central platform for seamless data accessibility, exemplify Takeda’s commitment to modernizing and standardizing enterprise platforms. beePFS stands as a beacon of innovation and efficiency within the broader pharmaceutical landscape.

Conclusion

Takeda’s beePFS project is a testament to the company’s commitment to innovation, adaptability, and excellence in project execution. By achieving remarkable success within an accelerated timeline, Takeda has demonstrated its capacity to overcome challenges and deliver outstanding results. The beePFS project enhances supply chain resilience and showcases Takeda’s dedication to pushing boundaries and achieving excellence.

For these reasons, Takeda Austria GmbH’s beePFS – Prefilled Syringe Filling project in Linz is proudly recognized as the 2024 ISPE FOYA Category Winner for Operations, Facility Fit.

Recognition and Achievement

The recipients of the 2024 FOYA category awards will receive formal recognition during the 2024 FOYA Banquet and Awards Celebration in Orlando, Florida, USA, scheduled for Sunday, 13 October 2024. This banquet, held as part of the 2024 ISPE Annual Meeting & Expo, will include acceptance speeches by the awardees, keynote sessions led by prominent industry figures, and ample networking opportunities with pharmaceutical manufacturing and engineering professionals. 

Register for the 2024 ISPE Annual Meeting & Expo and FOYA Banquet and Awards Celebration.

Read more about this recognition in the following article.

About the ISPE FOYA 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 the development of new applications of technology and cutting-edge approaches. 

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