ISPE has announced Takeda Pharmaceuticals International AG as the 2022 Facility of the Year Awards (FOYA) Overall Winner for their project TaSiVa located in Singen, Germany at the 2022 Membership Awards and Lunch during the 2022 ISPE Annual Meeting & Expo.
Takeda Pharmaceuticals International AG was awarded the 2022 FOYA Pharma 4.0™ Category Award in April 2022 for its TaSiVa Facility in Singen, Germany for their dengue vaccine candidate. Vaccines represent one of Takeda’s core therapeutic areas, and this project has provided capacity for almost 40 million vaccines per year while modernizing the site into a highly automated digital pharmaceutical facility.
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.
Takeda’s digital vision and strategy also included applying artificial intelligence and machine learning in several areas. An advanced algorithm was developed to select bags of drug substances for formulation based on a targeted potency model. The manual process of quantifying immune-stained foci for potency assay was converted to an automated system that could be initially trained using thousands of pictures and is targeted for fully automated counting in routine operations. AI enabled, automated visual inspection lyophilized product was developed with high accuracy and low false reject rates.
The project also implemented robotics where appropriate to improve efficiencies and reduce safety and ergonomic risks. Two collaborative robots were installed for the loading of syringes and vials onto the packaging lines and can work adjacent to the operators.
The Takeda TaSiVa project exemplifies how application of innovation in advanced digital technologies led to improved outcomes in terms of safety, product quality and productivity in a modern, pharmaceutical manufacturing facility using Pharma 4.0™ technologies.
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. Visit ISPE.org/FOYA for more information.