The FOYA program each year 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.

Takeda Pharmaceuticals International was awarded the 2022 FOYA Pharma 4.0 Category Award in April 2022 for its TaSiVa Facility in Singen, Germany for its dengue vaccine candidate. Vaccines represent one of Takeda’s core therapeutic areas. This project has provided capacity for almost 40 million vaccines annually while modernizing the site into a highly automated digital pharmaceutical facility.

From the beginning of the project, ISPE commented, the team introduced digital solutions to identify innovative Pharma 4.0 technologies which would support the delivery of the project by increasing productivity, quality, and efficiency of processes within the plant. They also conducted a significant IT infrastructure upgrade to ensure that the facility was fit 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 to load syringes and vials onto the packaging lines and can work adjacent to the operators.

The Takeda TaSiVa project exemplifies how the 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.