2024 ISPE FOYA Category Winner for Operations – Facility Fit

Takeda Austria GmbH 

Location: Linz, Austria  
Project: beePFS - Prefilled Syringe Filling

 2024 ISPE FOYA Category Winner for Operations

Takeda is a global values-based, R&D-driven biopharmaceutical leader committed to creating better health for people and a brighter future for the world. For more than 240 years, Takeda has focused on delivering transformative treatments and significantly increasing the value it brings to society. The work Takeda does transforms lives, helping patients with limited or no treatment options in some therapeutic areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

The manufacturing site in Linz, Austria, started in the late 1960s as a small molecule production site. It expanded over the years and developed into a manufacturing hub for Takeda’s oncology and biologics products.

The team at the Takeda site in Linz embarked on an exceptional venture, the beePFS project, a pioneering project in 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 challenges posed by the global COVID-19 pandemic and supply chain disruptions, Takeda's beePFS project achieved a remarkable success by making the project 50 percent faster than standard projects previously performed at Takeda and within the industry for similar scope.

There are five key factors that contributed to this accelerated timeline, they highlight Takeda's commitment to excellence through the Warp Speed program.

1. Super-Fast Track Execution - PPQ runs in 24 months: The beePFS project, as part of Takeda's Super-Fast Track WARP Speed program, has achieved the completion of all process performance qualification (PPQ) runs within a 24-month timeline. Despite challenges posed by the pandemic and supply chain disruptions, beePFS was 50 percent faster than standard projects, showcasing the project team´s dedication to rapid execution.

2. Innovative Technologies: With beePFS, Takeda has implemented innovative technologies such as augmented reality (AR) training and seamless integration of pre-use, post-sterilization integrity testing (PUPSIT) which is 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 ensures swift reaction times for sterile filter integrity tests. The Austrian AGES authority approval further validates beePFS's commitment to quality and regulatory excellence.

3. Transformational Impact and Facility Modernization: The introduction of prefilled syringe filling at the Linz facility has strengthened Takeda´s supply chain resilience in sterile syringe filling. The co-location of drug product activities optimizes supply chains and enhances 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.

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

5. Embracing Digitalization and Pharma 4.0: The integration of the manufacturing execution system (MES) and historian system, coupled with a high-level of 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.

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

Supply Partners and Key Participants:

Manufacturer/Owner Name: Takeda Austria GmbH

Engineer/Architect (A&E):

  • PROject Puhringer + Bisteghi GmbH
  • VTU Engineering GmbH
  • IHM – Ingenieurburo Hartmut Meier

Construction Manager: Trimont Consulting & Project Management

Main/General Contractor: OPTIMA pharma GmbH

Piping Subcontractor: SMB Pure Systems GmbH

HVAC Subcontractor: Molin Gesellschaft mbH. & Co KG

Major Equipment Suppliers/Contractors:

  • OPTIMA pharma GmbH
  • Korber Pharma Inspection GmbH
  • Mostl Anlagenbau GmbH