2026 ISPE Facility of the Year Awards (FOYA) Category Winner for Pharma 4.0™

Bayer AG

Location: Leverkusen, Germany
Project: SOLIDA-1

While traditionally, FOYA winning facilities highlight either breakthrough manufacturing platforms or mature operating sites with multi-year performance history, Bayer’s SOLIDA-1 submission stands out because it combines a scalable modular facility blueprint with an end-to-end autonomous manufacturing/logistics and digital execution stack. Based on the evidence in the submission, SOLIDA-1 is selected to be the Pharma 4.0 category winner.

SOLIDA-1 is Bayer AG’s modular oral solid dose “launch and supply” facility located at Chempark in Leverkusen, Germany, engineered to support pipeline variability through rapid reconfiguration and modular expansion. The facility uses a central “spine” connecting self-contained modules and is designed to expand with up to seven scalable production modules; Bayer has already initiated a first expansion module targeted to begin operations in 2027.

The facility is designed to support a wide range of oral solid dose manufacturing needs—from low-potency cardiovascular therapies to high-potency oncology compounds—and is presented as validated and ready for commercial start with an initial capacity claim of up to one billion tablets/year.

A central differentiator is the project’s automation and digital architecture, which includes extending the traditional automation pyramid through an orchestration layer and autonomous material flow with the ambition of “lights-out” manufacturing. Bayer implemented PAS-X MES on a Kubernetes cluster for scalability and availability and describes a deliberate design choice where validated recipes/setpoints remain on the process equipment, while the manufacturing executive system (MES) supplies target parameters and the process units perform GMP-critical verification (e.g., identity checks) prior to execution.

The submission further claims an integrated autonomous logistics approach (automated guided vehicles and robotics) in which a single MES recipe initiation can trigger automated material delivery, loading, weighing, unloading, and onward movement—supported by a facility “ballroom” concept intended to enable free robotic movement and uninterrupted end-to-end material flow. These elements collectively underpin the submission’s strongest FOYA arguments in Pharma 4.0™ (connected digital execution, automated electronic batch records, and data-enabled operations).

From a Pharma 4.0 perspective, Bayer also describes GenAI-enabled natural language access to manufacturing data for deviations, batch status, and equipment state, alongside paperless qualification/validation and digital workflow execution (e.g., ValGenesis and electronic execution through MES/SAP/digital checklists). These are credible markers of a connected, data-driven operating model backed by strong governance and data integrity controls.

Considering this comprehensive list of end-to-end digital enhancements and integration philosophy, Bayer’s SOLIDA-1 submission is a clear FOYA Category Winner for Pharma 4.0.