Spotlight on 2025 FOYA Category Winners
Attendees will have the unique opportunity to go behind the scenes of facilities that are redefining the boundaries of engineering.
- Innovation in Action: Touchlight (Hampton, London, UK), the 2025 ISPE FOYA Category Winner for Innovation, will showcase their newly built, cutting-edge facility for novel synthetic DNA called "doggy-bone DNA" (dbDNA™)—a masterpiece of modern engineering, located within a historic Victorian waterworks building and a leap forward for the future of gene therapies.
- Operational Excellence: Johnson & Johnson Innovative Medicine (Latina, Italy) will detail how their highly flexible bottle packaging line and its unique advanced control system allow for seamless automation. This project earned them recognition as the 2025 ISPE FOYA Category Winner for Operational Excellence.
- Project Execution: Johnson & Johnson Innovative Medicine (Ringaskiddy, Cork, Ireland) will outline the details behind the BioCork 3.2 Expansion Project—an endeavor of high complexity, as the plant continued its operations throughout construction—an achievement that earned them recognition as the 2025 ISPE FOYA Category Winner for Project Execution.
- Sustainability: Erbe Elektromedizin (Rangendingen, Germany) will introduce their Erbe Project 4.i Project, highlighting a truly innovative, sustainability-focused site—one of the first industrial buildings in Germany to achieve the rigorous KfW-40 efficiency house standard.
Strategic Execution: From Rapid Compliance to Global Replication
The track expands into real-world case studies where strategic governance and innovative partnerships have overcome traditional project bottlenecks.
- Accelerating Compliance: The Farmak Spain sterile facility project is remarkable, achieving Annex-1 Aseptic Process Simulation compliance in less than two years from project design to authorization inspection by means of remarkable strategic risk management and agile decision-making, enabling them to have a market-ready manufacturing site in record time.
- The Power of Partnership: Sandoz and VTU Engineering GmbH joined forces for a fast-track capital expenditures project in Slovenia. Their collaboration was the key to success. Experts will share how cross-company leadership steered over 150 professionals across 15+ locations, turning immense pressure into breakthrough progress.
- Bridging Borders: Replicating Facilities: A presentation by the PM Group will explore the replication of an Irish drug substance facility for the US market, comparing critical design nuances in HVAC, fire safety, and electrical standards between the EU and the US—an issue faced by the growing number of companies looking to duplicate GMP facilities across geographic borders.
Advancing Biopharma Technology and Compliance
A dedicated group of presentations will focus on the science and frameworks driving the next generation of bioprocessing.
- Science-Based Leak Assessment: A powerful new risk-assessment model will be introduced to evaluate leaks in closed biopharmaceutical systems. The presenters will explore an in-depth analysis that demonstrates how a leak does not necessarily mean contamination, thus opening the door to smarter decisions like reprocessing instead of immediate rejection.
- Breakthroughs in Viral Segregation: Inspired by challenges from the COVID-19 pandemic, presenters will describe a breakthrough framework for viral safety in biopharmaceutical manufacturing which improves traditional strategies by means of a streamlined “layers of protection” approach, showing how targeted controls, especially closed systems, provide the strongest foundation for viral segregation.
- Single-Use Component Interchangeability: Attendees will receive guidance on how to evaluate and qualify the interchangeability of single‑use components in biopharmaceutical manufacturing. They will learn about a risk‑based path meant to assess purpose, form, and function of single‑use components to help ensure uninterrupted manufacturing.
Digital Transformation and Project Foundations
To round out the track, presenters will shift their focus from physical structures to the digital and procedural foundations that ensure long-term success.
- Connected Frontlines at Eli Lilly & Company: Presenters from Eli Lilly and Tulip will trace the global rollout of a digital frontline platform for compliant logbooks and will highlight the stepwise approach to validating digital solutions in a GMP environment, reducing manual errors through real-time visibility.
- The Commissioning, Qualification, and Validation (CQV) Early Engagement Checklist: Presenters will introduce a practical checklist to help CQV managers effectively lead projects by addressing foundational elements early in the project lifecycle—from basis of design through detailed design—providing clear direction for an efficient CQV path aligned with the ISPE C&Q Baseline Guide (Second Edition), a globally recognized industry guideline.
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