拜耳SOLIDA-1如何以自主运营与Pharma 4.0™变革口服固体制剂生产——2026 ISPE FOYA运营卓越与Pharma 4.0™类别获奖设施解析

In a recent episode of ISPE Podcast: Shaping the Future of Pharma, Jürgen Wiedemann, Head of Pharma Technology Systems at Bayer AG, and Christoph Ebbecke, Venture Manager at Bayer AG, shared the story behind SOLIDA-1, the recipient of the 2026 ISPE Facility of the Year Awards (FOYA) Operational Excellence and Pharma 4.0™ category awards.

Their discussion offered valuable insights into how Bayer reimagined oral solid dosage manufacturing through an innovative ballroom manufacturing concept, integrated autonomous operations, digital connectivity, and a future-ready facility design that challenges conventional assumptions about pharmaceutical production.

What Is Bayer's SOLIDA-1 Facility?

SOLIDA-1 is Bayer AG's next-generation launch and supply facility for non-hormonal oral solid dosage products. Located in Leverkusen, Germany, the facility was designed to replace aging manufacturing infrastructure while creating a platform capable of supporting pharmaceutical production for decades to come.

Rather than simply replicating existing manufacturing models, the project team approached SOLIDA-1 as an opportunity to fundamentally rethink how oral solid dosage products are developed, manufactured, and delivered to patients.

According to Wiedemann, nearly every aspect of traditional manufacturing was challenged during the design process, from equipment selection and material flow strategies to automation architecture, maintenance concepts, data integration, and facility layout.

The result is not simply a new manufacturing plant. It is a highly adaptable manufacturing platform designed to support future growth, rapid product launches, and continuous operational improvement.

How Does SOLIDA-1 Balance Speed, Flexibility, and Quality?

One of the most compelling themes from the podcast conversation was Bayer's decision to challenge the traditional belief that manufacturers must choose between speed, flexibility, quality, and cost.

Many conventional pharmaceutical facilities are optimized around specific products, technologies, or production capacities. SOLIDA-1 was designed differently.

The facility was built around three primary objectives:

• Accelerate patient access through faster product launches and technology transfers
• Deliver high-quality products consistently
• Maintain competitive manufacturing costs across a diverse and evolving product portfolio

To achieve these goals, Bayer focused heavily on modularity and automation.

The facility's modular architecture allows manufacturing capabilities to expand, adapt, or evolve as business needs change. At the same time, integrated automation and digital systems help manage operational complexity without sacrificing efficiency.

As Ebbecke explained, SOLIDA-1 functions less like a traditional production plant and more like an adaptable manufacturing platform that will continue to evolve over time.

The Ballroom Manufacturing Concept: A New Approach to Oral Solid Dosage Production

One of SOLIDA-1's most distinctive innovations is its ballroom manufacturing concept.

Traditional pharmaceutical facilities typically isolate major manufacturing processes in separate rooms. While effective, this approach introduces numerous barriers that can interrupt production flow and limit flexibility.

SOLIDA-1 takes a different approach.

Rather than separating equipment across multiple rooms, major process units are located within a large multifunctional production space known as the ballroom.

This open manufacturing environment enables:

• Free movement of automated guided vehicles (AGVs)
• Flexible robotic material transport
• Simplified equipment access for maintenance
• Faster process reconfiguration
• Greater manufacturing adaptability

The ballroom design also contributes to approximately 25 percent savings in building footprint compared to traditional facility layouts by eliminating redundant logistics corridors and support spaces.

Importantly, flexibility does not come at the expense of productivity. The facility can support multiple simultaneous production batches while maintaining efficiency and operational performance.

How Autonomous Operations and Pharma 4.0™ Work Together

SOLIDA-1 earned recognition in both the Operational Excellence and Pharma 4.0™ categories because of its deeply integrated approach to automation and digitalization.

Rather than implementing isolated automation tools, Bayer focused on creating a connected manufacturing ecosystem that links:

• Enterprise resource planning (ERP) systems
• Manufacturing execution systems (MES)
• Production equipment
• Robotics
• Automated guided vehicles
• Logistics systems
• Real-time manufacturing data

One standout innovation discussed during the podcast was Bayer's custom-developed Production Flow Control (PFC) system.

The PFC system serves as the orchestration layer connecting material movement with manufacturing execution. It continuously monitors logistics equipment, generates transport instructions, and coordinates AGV activity throughout the facility.

Functions traditionally managed by operators are now supported through intelligent automation, enabling greater efficiency while maintaining visibility and control.

This integrated ecosystem represents Pharma 4.0™ in practice: connecting people, systems, equipment, and data into a unified operational environment.

The Role of Digital Twins, Data, and Artificial Intelligence

The conversation also highlighted how digital twins and advanced data strategies are helping shape the future of pharmaceutical manufacturing.

During facility design, Bayer developed a virtual model of SOLIDA-1 that allowed operators and project teams to navigate the facility before construction was completed. Using gaming-engine technology, users could virtually walk through manufacturing spaces, evaluate workflows, and identify potential improvements before installation.

Perhaps more importantly, SOLIDA-1 was built around a robust data infrastructure.

Real-time operational data is continuously collected across manufacturing systems and consolidated into an integrated data environment. This foundation supports:

• Process modeling
• Technology transfer activities
• Predictive analytics
• Digital twin development
• Future AI applications

Both guests emphasized that artificial intelligence's greatest value may ultimately come from process optimization and advanced statistical analysis rather than standalone generative AI tools.

At the same time, generative AI already has practical applications. Operators can use AI-powered tools to search manufacturing records, investigate deviations, and access critical information more efficiently.

How Automation Is Changing Workforce Roles

A key takeaway from the discussion is that automation is not eliminating the need for people. Instead, it is transforming how people contribute.

Historically, manufacturing teams often spent significant time collecting data before they could begin solving problems.

In highly automated environments such as SOLIDA-1, data is immediately available. Employees can focus on:

• Process optimization
• Root cause analysis
• Continuous improvement
• System oversight
• Decision-making

As a result, future pharmaceutical professionals will need broader process knowledge, stronger digital skills, and a deeper understanding of interconnected manufacturing systems.

Automation enhances human expertise rather than replacing it.

Looking Ahead

Bayer's SOLIDA-1 facility demonstrates what becomes possible when organizations combine bold thinking, disciplined project execution, and a long-term vision for pharmaceutical manufacturing.

Through modular facility design, autonomous operations, integrated digital systems, and a commitment to continuous improvement, SOLIDA-1 exemplifies why it was recognized as a 2026 ISPE Facility of the Year Awards winner in both Operational Excellence and Pharma 4.0™.

As the pharmaceutical industry continues to evolve, projects like SOLIDA-1 provide valuable insights into how manufacturers can improve agility, accelerate product delivery, strengthen operational performance, and better position themselves to adapt to future technologies and market demands.

Listen to the Episode

Discover insights from Bayer AG's award-winning SOLIDA-1 facility as Wiedemann and Ebbecke discuss autonomous operations, modular manufacturing, Pharma 4.0™, and the strategies behind this 2026 FOYA-winning project.

LISTEN TO THE EPISODE>