Inside Bayer AG's 2026 ISPE FOYA Category Award-Winning Project for Operations Excellence and Pharma 4.0™

Spanning approximately 205,000 square feet, SOLIDA-1 was built with a clear mission: to accelerate the delivery of increasingly complex medicines through a flexible, digitally integrated manufacturing platform capable of rapid scale-up, operational excellence, sustainable performance, and continuous innovation.

A New Model for Pharmaceutical Manufacturing

The pharmaceutical industry faces growing pressure to shorten development timelines, launch therapies faster, and respond more effectively to changing patient needs. Bayer designed SOLIDA-1 specifically to address these challenges.

The facility manufactures a variety of oral solid dose (OSD) products, including cardiovascular medicines and high-potency oncology therapies. Unlike traditional manufacturing facilities that are often tailored to a limited range of products, SOLIDA-1 was designed as an adaptable platform capable of supporting multiple products and production scales.

One of the facility’s most significant advantages is the co-location of clinical and commercial manufacturing. By bringing these functions together, Bayer can transfer processes more efficiently, scale production seamlessly, and accelerate the path from development to market. According to Bayer, the facility can reduce time-to-market by as much as one year while supporting production volumes from initial launch batches to as many as one billion tablets annually. At the same time, SOLIDA-1 improves manufacturing efficiency by increasing equipment effectiveness and reducing workforce requirements through extensive automation and digitalization.

Why SOLIDA-1 Stood Out in the Pharma 4.0 Category

The ISPE Pharma 4.0 category recognizes organizations that go beyond implementing individual technologies and instead transform their culture, processes, and workforce around a digitally enabled future. SOLIDA-1 exemplifies this vision through a highly connected manufacturing ecosystem that integrates:

• Advanced robotics
• Automated guided vehicles (AGVs)
• Manufacturing execution systems
• Electronic batch records
• Integrated data platforms
• AI-enabled data access and analytics
• End-to-end digital workflows

Together, these technologies create an environment where manufacturing operations are largely autonomous, paperless, and data-driven.

Rather than treating automation as a collection of isolated systems, Bayer developed a fully integrated digital architecture that enables processes, equipment, and personnel to operate within a single coordinated framework. The result is a manufacturing environment that supports consistent execution, improved decision-making, and enhanced operational visibility.

Modular Design as a Competitive Advantage

A defining feature of SOLIDA-1 is its modular design philosophy, which extends across technology, process, and facility architecture.

Modular Technologies

The facility was engineered to accommodate future growth and technological evolution. New equipment can be integrated quickly through standardized interfaces and platform concepts that enable rapid qualification and deployment.

As Juergen Wiedemann, Strategic Program Lead at Bayer AG, explained, pharmaceutical facilities must strike a balance between standardization and adaptability. While standardization enables efficiency and repeatability, pharmaceutical manufacturing requirements still demand customized solutions.

SOLIDA-1 achieves this balance through a combination of proven technologies and custom-developed innovations, including specialized robotics, process-compatible containers, and proprietary production flow control systems designed to support autonomous operations.

Flexible Process Design

The modular approach also extends to manufacturing processes. Each production module concentrates support infrastructure and utilities at the front of the space, leaving a large open production area that can be configured for different manufacturing technologies and product requirements. This approach allows Bayer to modify equipment layouts, introduce new technologies, and adapt manufacturing processes with minimal disruption. The result is a facility capable of supporting evolving product portfolios while maintaining efficiency and scalability.

Scalable Building Architecture

The building itself follows a modular concept consisting of independent production modules connected by a central operational spine. This structure enables a "copy-and-paste" expansion model that reduces project risk, cost, and implementation time for future growth.

Administrative functions and manufacturing areas are intentionally separated, ensuring that complex systems such as HVAC, containment infrastructure, GMP utilities, and fire protection are implemented only where required. This targeted approach reduces complexity, lowers operating costs, and improves maintainability while maintaining full regulatory compliance. According to Wiedemann, this modular strategy could become a blueprint for future greenfield pharmaceutical facilities seeking greater flexibility and resilience.

Redefining Operational Excellence

SOLIDA-1’s second award recognizes its exceptional achievements in operational excellence.

The facility incorporates automation into nearly every stage of production, including:

• Material handling
• Automated weighing
• Formulation processes
• Compression
• Coating operations
• Equipment cleaning
• Intralogistics
• Electronic documentation

These processes are connected through an integrated automation ecosystem that significantly reduces manual intervention and enhances process consistency.

Importantly, Bayer emphasizes that automation is not intended to eliminate people from manufacturing. Instead, it shifts personnel away from repetitive tasks and toward higher-value activities such as oversight, quality management, technical support, exception handling, and continuous improvement.

This approach improves both operational efficiency and workforce effectiveness while supporting the industry's increasing focus on quality and compliance.

The Industry’s First Ballroom Concept for OSD Manufacturing

One of SOLIDA-1’s most innovative features is its open ballroom manufacturing concept, a first for OSD production. Traditional pharmaceutical production environments often rely on fixed layouts and physical barriers that restrict movement. SOLIDA-1 removes many of these limitations, allowing robots, AGVs, materials, and equipment to move freely throughout the manufacturing space.

This open architecture creates a more flexible production environment and establishes the foundation for future automation technologies. It also enables rapid reconfiguration as manufacturing needs evolve. By designing the facility around movement, connectivity, and flexibility, Bayer has created an environment better suited for digital manufacturing than conventional pharmaceutical plants.

Building Toward the Future of Pharma 4.0

While SOLIDA-1 already represents one of the industry's most advanced pharmaceutical manufacturing facilities, Bayer views it as a foundation rather than a final destination. The company’s long-term vision centers on increasing manufacturing autonomy through technologies such as:

• Digital twins
• Predictive and prescriptive maintenance
• Real-time quality monitoring
• AI-supported decision-making
• Predictive quality systems
• Plug-and-produce equipment integration

SOLIDA-1 already includes many of the building blocks necessary for this evolution, including near-real-time data collection, cloud-based data storage, process analytical technology, automated statistical process analysis, and AI-enabled use cases. These capabilities move the facility beyond simple automation and toward truly intelligent manufacturing, where data continuously drives optimization, supports faster root-cause analysis, and improves product launch performance.

A Blueprint for the Next Generation of Facilities

By earning 2026 ISPE FOYA Pharma 4.0 Category Winner recognition and Operations – Operational Excellence Category Winner recognition, Bayer’s SOLIDA-1 facility has demonstrated what is possible when digital transformation, modularity, and operational excellence are built into every aspect of manufacturing.

The facility not only accelerates the delivery of critical medicines but also offers a compelling model for the future of pharmaceutical production: one that is modular in design, autonomous in execution, intelligent in decision-making, and sustainable in operation. As the pharmaceutical industry continues its transition toward advanced manufacturing and digital integration, SOLIDA-1 stands as a powerful example of how innovation can transform both operational performance and patient access to life-changing therapies.

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