Pharma 4.0™ Interconnected Facility Design and Construction

Join ISPE for a series of insightful presentations that showcase how Pharma 4.0™ is reshaping the way pharmaceutical plants are designed, constructed, and managed to meet the demands of tomorrow's digital landscape.

Planning for the Future with Pharma 4.0™ in a Greenfield: Building the Next Generation Facility

Designing a greenfield pharmaceutical site that will be operational in five years requires more than just vision—it demands precise, forward-thinking strategies to integrate future-ready technologies. In this presentation by Alan Bateman, Director, Systems Architecture, Digital and Execution with Johnson & Johnson Innovative Medicines, will delve into practical applications of Pharma 4.0™ to ensure new greenfield sites are equipped to meet the evolving needs of the industry by 2030.

Focusing on the full ISA-95 systems landscape, the session will explore how Pharma 4.0™ principles can be applied across all phases of project development. Attendees will learn about key tools, processes, and best practices, including:

• Project phase considerations: From concept to commissioning, ensuring each step is aligned with future technological advancements
• Benchmarking and guidance: Utilizing standards from professional bodies to future-proof site designs
• Maturity models: Adapting digital frameworks to create scalable, smart facilities that are sustainable and efficient

This session offers invaluable insights for those looking to harmonize their aspirations with practical design strategies, ensuring the creation of an innovative and adaptable facility that’s ready for the challenges and opportunities of the future.

The Journey Towards a Lights-Out Operation: Achieving Autonomous Biomanufacturing

Imagine a biomanufacturing facility running autonomously, with seamless, continuous operations and minimal human intervention—this is the future of "lights-out" operations. While industries like automotive and electronics have already embraced this shift, biomanufacturing faces distinct technical and regulatory hurdles that complicate the path forward.

In this presentation, Charles Heise, Associate Director, BioProcess Strategy and Development with FUJIFILM Diosynth Biotechnologies will share their groundbreaking work, having identified over 100 gaps in continuous downstream bioprocessing. Through a detailed risk assessment blueprint, they have developed solutions to simplify control at the unit operation level. Key topics include:

• Risk assessment and mitigation: Understanding and addressing the critical risks that stand in the way of fully autonomous operations
• Control and connectivity: Streamlining process control and ensuring robust system integration for end-to-end automation
• Overcoming challenges: Practical strategies for tackling technical, operational, cultural, and regulatory barriers

Attendees will gain a comprehensive roadmap for transitioning to autonomous bioprocess control, offering insights into the steps needed to bring this vision of lights-out biomanufacturing to life.

Bridging Pharma 4.0™ & Annex 1 Compliance on Fast Track: Accelerating Innovation in Sterile Manufacturing

Takeda Austria GmbH’s Linz beePFS project, which will be presented by Christina Stern, Sterile Production, Production Lead Syringe, with Takeda Austria GmbH, and Martin Rabb, CAPEX and Project Management Lead, Takeda Austria GmbH, is a breakthrough in combining the principles of Pharma 4.0™ with rapid Annex 1 compliance. This "super warp speed" initiative focuses on implementing a cutting-edge prefilled syringe filling line that drastically shortens process performance qualification (PPQ) times, ensuring faster time-to-market without compromising quality or safety.

The presentation will highlight:

• Supply security: Strengthening production reliability to meet increasing global demand for sterile products
• Risk reduction: Leveraging Pharma 4.0™ technologies to minimize operational and compliance risks during the production process
• Enhanced flexibility: Adopting innovative approaches to increase adaptability and scalability in syringe filling operations
• Regulatory alignment: How Takeda swiftly integrated the latest Annex 1 guidelines into their manufacturing processes to ensure compliance

Attendees will discover how Takeda effectively merged cutting-edge technology with regulatory requirements to drive innovation while ensuring product quality and supply chain security. This case study offers valuable insights into accelerating pharmaceutical production while adhering to the latest industry standards.

Continuous API Pharma 4.0 Factory-by-Design: Transforming Manufacturing for the Future

Building on the success of the 2023 presentation, "Roadmap to Deliver Real Value from Pharma 4.0™," this session by Simon Webb, Founder and CEO of Liminos and Simon Capewell, Head of OT and Digital Solutions with AstraZeneca, offers a deep dive into the practical approach of designing and operationalizing next-generation Pharma 4.0™ facilities. Focused on continuous API production, this presentation will showcase how to transform both greenfield and brownfield sites into efficient, data-driven, and technology-enabled operations.

Key takeaways will include:

• Vision and strategy development: Crafting a clear and actionable roadmap for Pharma 4.0™ implementation
• Technology integration: Leveraging cutting-edge digital tools to enhance process efficiency and product quality
• Process redesign and workforce transformation: Understanding how to align technology with redesigned workflows and upskilling teams for the digital future
• Avoiding common project pitfalls: Practical insights into overcoming challenges encountered during project design and execution
• Case studies and real-world examples: Learn from successful implementations of continuous API production, highlighting both challenges and triumphs

Attendees will leave with actionable strategies to drive continuous API manufacturing and unlock the true potential of Pharma 4.0™ in their own facilities, accelerating the shift toward smarter, more agile production models.

Flexible Biomanufacturing in Pharma 4.0: Redefining Facility Design for Agility and Efficiency

The biopharmaceutical industry is embracing the future with the "ballroom" concept, prioritizing flexibility and adaptability in facility design. In this presentation, Guido Kremer-van der Kamp, Senior Consultant, Global BioPharm Center of Excellence with Merck Chemicals GmbH will share the journey toward implementing Pharma 4.0™ principles and the challenges of building fully connected digital plants.

Key topics include:

• Designing interconnected, flexible facilities: How to balance the flexibility of open ballroom concepts with advanced interconnected systems
• Closed systems and modular designs: Exploring innovations that enable seamless scalability and faster changeovers
• Digital twins and advanced simulations: Leveraging virtual models to optimize operations and predict outcomes before making physical changes
• Industry standards and consortia collaborations: Insights from recent publications and industry initiatives that are shaping the future of biomanufacturing

Attendees will discover how cutting-edge technologies and flexible design strategies are transforming biomanufacturing processes, enabling companies to respond more quickly to market demands, reduce costs, and improve efficiency. Don’t miss this opportunity to learn how to future-proof your facility with Pharma 4.0™ innovations!

Supply Chain Solution via Cloud-Based Analytics and NIR-Scanners: Combating Counterfeit Medicines with Cutting-Edge Technology

In the fight against falsified medicines, ensuring supply chain integrity is paramount. This presentation by Dominik Rabus, PhD, CEO, RABUS.TECH and Theophile Sebgo, Anti-Falsified Medicines Director with Novartis will unveil a breakthrough cloud-based analytical drug screening solution that enables rapid, local detection of counterfeit drugs.

Key highlights include:

• AI-powered authentication: How mobile devices equipped with spectral sensors and AI-driven analytics can instantly verify the authenticity of pharmaceuticals
• Accelerated detection: Drastically reducing the time required for drug authentication, empowering local health and law enforcement authorities to respond swiftly
• Enhancing supply chain security: Leveraging data science to monitor and protect pharmaceutical supply chains from counterfeit threats
• Strengthening public health protection: How this technology is being deployed globally to safeguard patients and combat the rising issue of counterfeit drugs

Attendees will gain invaluable insights into the development and deployment of this innovative solution, learning how it revolutionizes drug authentication and strengthens global efforts to secure pharmaceutical supply chains. Don't miss this opportunity to explore the future of supply chain security!

Conclusion

The Pharma 4.0™ Interconnected Facility Design and Construction track promises to provide a wealth of knowledge—exploring the latest technologies, strategies, and regulatory considerations in pharmaceutical manufacturing. Attendees will leave with a deeper understanding of how to navigate the complexities of Pharma 4.0™, drive innovation, and ensure compliance in a rapidly evolving industry. Join industry leaders and visionaries as they chart the course for the future of the pharmaceutical industry. This is the chance to stay ahead of the curve and be part of the transformation shaping the pharmaceutical landscape.

Learn More & Register

Learn more about Pharma 4.0™ and how to effectively implement digitalization projects with the ISPE Baseline® Guide: Pharma 4.0™.