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Meet the 2022 FOYA Pharma 4.0™ Category Winner: Takeda

Marcy Sanford

Pharma 4.0™ is a new category for the Facility of the Year Awards (FOYA) program. Winners in the Pharma 4.0 category embody the Pharma 4.0 concept. This includes not only implementing at least one technological innovation, but also demonstrating the ability to change the company’s culture, processes, and people orienting them towards a 4.0 future. Significant contributions include application of one or more applied science-based solutions or digital innovations like automation, robotics, digital twin, or advanced processing understanding; substantial improvement to operational practices; or technologies widely and strategically implemented across the organization.

Meet the 2022 FOYA Pharma 4.0™ Category Winner: Takeda

Takeda won the Pharma 4.0 FOYA for their innovative solutions in its facility, constructed for Takeda’s dengue vaccine candidate in Singen, Germany. According to the World Health Organization, the number of reported dengue cases has dramatically increased over the last two decades, from 505,430 cases in 2000, to over 2.4 million in 2010, and 5.2 million in 2019. Reported deaths between the year 2000 and 2015 increased from 960 to 4032, affecting a mostly younger age group.

Dengue is caused by four distinct but closely related dengue virus serotypes. Takeda’s vaccine candidate, TAK-003, is designed to protect against all four types of the dengue virus. From the beginning of the project, the team introduced digital solutions with the objective to identify innovative Pharma 4.0 technologies which would support the delivery of the project by increased productivity, quality, and efficiency of processes within the plant. They also conducted a significant IT infrastructure upgrade to ensure that the facility was fit for purpose to operate as a highly automated facility.

The facility is connected to a central logistics spine on the Singen site. The spine connects all the existing and new manufacturing areas to the finished product warehouse on the existing site. The temperature-controlled requirements of the vaccine candidate presented a unique challenge which the team solved by re-engineering the facility; introducing a two-way logistics flow and increasing the level of automation which included the introduction of autonomous mobile robots (AMRs). The AMRs form part of the Singen warehouse management system, which is interfaced to the manufacturing execution system in the facility. The result is a seamless automated transport of raw materials to production areas as well as the final transfer of finished goods to the warehouse.

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The full automation strategy was also applied to the packaging process. The packaging hall is divided into two packaging lines which pack the final product. Before and during the project, Takeda’s Global Manufacturing and Supply organization was already undergoing a significant digital and data transformation which led to the modernization and standardizing of platforms for the enterprise and a move toward a more scalable, secure, and flexible cloud architecture. By utilizing Takeda EDB (Enterprise Data Backbone), coupled with the electronic batch record system, the performance of the plant can be monitored in real time via the facility’s control tower.

The project has a high degree of vertical and horizontal systems integration which enabled the project team to identify opportunities where machine learning and artificial intelligence could be developed to support the manufacturing process. The project team identified three machine learning opportunities for both operations and quality control: drug substance bag selection, including automated dosing, automated FOCI counting in QC, and semi-automated visual inspection.

The Takeda TaSiVa project is recognized with the FOYA 2022 in the category Pharma 4.0 as it exemplifies how the application of innovation in advanced digital technologies leads to improved outcomes in terms of safety, product quality, and productivity in a pharmaceutical manufacturing facility.

FOYA judges

About Takeda: Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

Nominate Your Facility for the 2023 FOYA Program!

Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2023 FOYA program winner. Applications must be submitted by 2 December 2022.