Building the Future: Innovative Facility Design at the 2025 ISPE Pharma 4.0™ Conference
The pharmaceutical industry is under constant pressure to expand capacity, accelerate time-to-market, and ensure reliable access to critical medicines. As more therapies gain regulatory approval and blockbuster drugs scale rapidly, the need for smarter, more resilient facilities has never been greater. That is why ISPE is particularly excited about the Innovative Facility Design track at the 2025 ISPE Pharma 4.0™ Conference, which takes place 9–10 December in Barcelona and virtually.
This track goes far beyond blueprints and equipment specifications. It highlights not just the latest engineering and technology innovations, but also the cultural and workforce considerations that make—or break—new facility projects. For pharmaceutical manufacturing engineers, these case studies and discussions will offer a roadmap to building facilities that are digitally enabled, people-centered, and capable of supporting the next wave of Pharma 4.0™ transformations.
Why Innovative Facility Design Matters
Pharma manufacturing projects are never simple. Between regulatory requirements, multimillion-dollar budgets, and the complexity of integrating equipment, systems, and people, it’s no wonder so many projects run into delays or overruns. Yet the demand for more capacity—and smarter capacity—only grows.
Innovative facility design means thinking differently about how we plan, build, and operate. It requires integrating digital tools like digital twins and predictive maintenance right from the design stage, rather than bolting them on later. It also means designing for flexibility—because product portfolios, regulations, and patient needs will continue to evolve. Finally, it calls for investment in people: ensuring that operators, engineers, and quality professionals have the skills and culture needed to thrive in new, digital-first environments.
This track brings together real case studies from AstraZeneca, Novo Nordisk, Vertex, Northern Life Sciences, and more to show how leading companies are meeting these challenges head-on.
“In the last five years, I’ve followed a lot of expansion projects, driven by obsolescence management or market demand growth,” said Giuseppe Di Vietri, Operation Technology, Digital, and Data Associate Director, Merck Serono S.P.A. “In all of those projects, it was such a quick win having adopted Pharma 4.0 requirements from the early design phase. Thanks to this strategy, the project’s organization was able to deliver to manufacturing teams digital-ready plants, connected to the state-of-the-art information technology/operational technology infrastructure, equipped with MES and Data Historian, and prepared for upcoming challenges.”
Session Highlights and Why They Matter
“New Facilities: Applying MES/Pharma 4.0™ Baseline Guides”
Presented by:
This case study will show how ISPE Guidance Documents were applied to help a leading life sciences company implement and validate a new facility. Attendees will see how the organization went from basic connectivity to a fully interconnected plant, with risk assessments, interdisciplinary teamwork, and phased implementation all playing key roles.
Why it matters for engineers: Guidance documents often seem abstract—but this session demonstrates how they translate into practical project steps. For anyone working on a greenfield or expansion project, the lessons here can reduce risk and accelerate time-to-commission.
“Designing for Pharma 4.0™: The Practical Considerations”
Presented by:
AstraZeneca’s new API Clinical and Commercial Manufacturing Facility in Dublin is a state-of-the-art digital smart factory. This presentation will break down what it takes to embed Pharma 4.0 principles from the earliest design stages: IT/OT integration, infrastructure needs, automation and instrumentation choices, data transparency, predictive maintenance, digital twins, and more.
Why it matters for engineers: Incorporating these requirements early can save enormous amounts of rework later. This session will help attendees understand what questions to ask at the start of a project—and how to design facilities that are not only compliant but also adaptable to future technologies.
This use case will be able to mark how much important is to plan all Pharma 4.0 principles starting from the concept design. Having considered them, end-to-end, since the beginning of the project, delivered a tangible transformation at the facility.
“Creating a Digital Item Path Without a Unique Identifier Device (UID)”
Presented by:
In parenteral manufacturing, tracking individual units upstream is notoriously difficult without physical identifiers like RFID or 2D codes. This session presents a cost-effective alternative: leveraging process and verification data already collected at the station level to create a digital “item path.” By transforming statistical time-series data into structured, unit-linked insights, manufacturers can achieve full upstream visibility into each item’s journey.
Why it matters for engineers: This approach could unlock major efficiency gains—streamlined deviation investigations, targeted recalls, golden batch comparisons, predictive maintenance—all without the overhead of new physical UID systems.
“Skilling Those Who Accelerate Pharma 4.0™ Transformations”
Presented by:
Technology alone cannot transform pharma. This session focuses on the workforce dimension: hiring, skilling, and upskilling the people who will run the facilities of the future. The presenters will highlight cultural enablers, key roles, and learning paths that support Pharma 4.0 transformations.
Why it matters for engineers: A facility is only as good as the people operating it. Engineers will gain insight into how their roles are evolving, what new skills are in demand, and how organizations can better prepare their workforce for success in digital-first environments.
Projects applying Pharma 4.0 paradigm often requires also strong change management capabilities and focus on people development and upskilling. Although delivering state-of-the-art technology is quite a complex task and see the need of a project team with specific skills, it’s only with end-user readiness that enterprises could fully capitalize the investments.
Key Takeaways for Manufacturing Engineers
- Design with digital in mind: Building Pharma 4.0 principles into the foundation of a facility avoids costly rework and ensures future adaptability.
- Leverage guidance documents: ISPE baseline guides aren’t just theory—they can be powerful tools for structured, risk-based project execution.
- Innovate in traceability: Even without physical UIDs, creative use of process data can unlock new levels of visibility and compliance.
- Invest in people: Facilities succeed when the workforce is skilled, empowered, and culturally aligned with transformation goals.
What’s Exciting About This Track
The Innovative Facility Design track speaks directly to the challenges engineers face every day. The content will be helpful for professionals working on projects across the facility design and development lifecycle including starting new build, upgrading an existing plant, handling obsolescence, or exploring digital transformation —the lessons shared here are practical, tested, and actionable.
“I’m very excited to moderate this track and to hear the best practices and lessons learned from some of the most important global players in the pharmaceutical landscape,” said Di Vietri. “I’m also eager to see you join us in Barcelona for our track Q&A session, where you’ll be able to really get the best advice from experienced professionals who have already made this journey.”
The demand for pharmaceutical capacity will only grow in the coming years. Meeting that demand requires facilities that are smarter, more flexible, and more people-centered than ever before. The 2025 ISPE Pharma 4.0™ Conference offers a rare opportunity to learn directly from companies and experts who are already making this future a reality.
“As a program committee member, I believe the Innovative Facility Design track will leave attendees with not just inspiration, but also practical roadmaps to bring back to their own organizations. If you’re looking for insights that will help you design and deliver the facilities of tomorrow, this is the track you can’t afford to miss,” concluded Di Vietri.
