ISPE 2026 Pharma 4.0™与生物制药大会「Pharma 4.0™ in Action：生物制药生产转型」专场：AI、数字孪生与自动化实例

These questions will be explored throughout the Pharma 4.0™ in Action: Biopharma Manufacturing Transformation track at the 2026 ISPE Pharma 4.0™ and Biopharma Conference, taking place 10-11 December in Berlin, Germany, and virtually.

While the Pharma 4.0™ Enabling Digital Foundations track examines the technologies, architectures, and data environments that support digital transformation, and the Pharma 4.0™ Compliant by Design track focuses on building regulatory trust in increasingly digital operations, the Pharma 4.0™ in Action: Biopharma Manufacturing Transformation track highlights how organizations are putting these concepts into practice.

Through real-world case studies spanning traditional biologics, plasma fractionation, advanced therapy medicinal products (ATMPs), cell and gene therapies, and aseptic fill-finish manufacturing, industry leaders will demonstrate how trusted data ecosystems, artificial intelligence (AI), advanced analytics, robotics, digital twins, and smart manufacturing approaches are improving operational performance while maintaining quality, compliance, transparency, and accountability.

What Is Pharma 4.0™ in Biopharmaceutical Manufacturing?

Pharma 4.0™ is the application of connected digital technologies, trusted data, advanced analytics, intelligent automation, and modern manufacturing principles across the pharmaceutical product lifecycle. In biopharmaceutical manufacturing, Pharma 4.0™ helps organizations improve efficiency, strengthen quality systems, accelerate decision-making, reduce process variability, and enhance operational visibility.

Successful Pharma 4.0™ implementation is not defined by technology alone. It requires integrating digital capabilities into business processes, manufacturing operations, and quality systems in ways that enable people to make faster, more informed decisions while maintaining regulatory compliance and patient safety.

The Pharma 4.0™ in Action: Biopharma Manufacturing Transformation track explores how leading organizations are accomplishing exactly that.

What Will Attendees Learn in the Pharma 4.0™ in Action: Biopharma Manufacturing Transformation Track?

Attendees will learn how biopharmaceutical manufacturers are applying Pharma 4.0™ technologies to real operational challenges across manufacturing, engineering, quality, and process development. Through implementation-focused case studies and lessons learned, speakers will demonstrate how digital transformation initiatives can deliver measurable value while preserving human oversight and accountability.

Key takeaways include:

How AI can augment human expertise in regulated manufacturing environments
Why organizational design is critical to smart-factory success
How digital twins support engineering and operational excellence
Strategies for modernizing deviation management
The role of data governance in scaling AI initiatives
How robotics can accelerate process development
Opportunities to improve aseptic manufacturing performance
Practical approaches to scaling cell and gene therapy manufacturing

How Can Pharmaceutical Manufacturers Use AI While Maintaining Human Oversight?

Few technologies have generated more discussion within pharmaceutical manufacturing than AI.

In "Augmented, Not Automated: Keeping Humans in the Loop," Brice Dreamer and Michael Ruck of Eliquent Life Sciences explore how organizations can adopt AI responsibly while maintaining accountability, compliance, and quality. Rather than presenting AI as either a replacement for human expertise or a universal solution, the session examines where AI can provide the greatest value today and where human judgment remains essential.

Attendees will gain practical insights into current and future AI applications, the risks associated with overreliance on automated outputs, and evolving requirements such as the EU AI Act and draft EU GMP Annex 22. The session reinforces an important Pharma 4.0™ principle: successful implementation depends on augmenting human expertise, not replacing it.

Why Does Organizational Design Matter for Smart Factories?

Technology investments alone do not create successful smart factories.

In "Blueprint for the Smart Factory: Why Organizational Design Matters More Than Technology," Tobias Merz of Bachem AG shares lessons learned from a major capital investment project that incorporated an Industry 4.0 vision from the outset.

The presentation explores how project governance, organizational structures, and cross-functional collaboration can support digitalization and integrated manufacturing objectives. By examining how future operating models can be embedded into project execution, the session highlights why a clear vision for end-to-end integration is critical to both project success and long-term operational excellence.

How Are Engineering Data and AI Improving Design Review?

As facilities become larger and more complex, access to accurate engineering information has become increasingly important.

In "Piping and Instrumentation Diagrams (P&IDs) Turned Data as Backbone for Design Review," Kasper Olsen of Kuatro Group and Mikkel Wilmann of Novo Nordisk demonstrate how engineering data can be transformed into a strategic asset.

Using a major facility expansion involving more than 45,000 components and nine million data points, the speakers show how AI-assisted data capture can convert information embedded within P&IDs, component specifications, and tag lists into structured, reusable data. The result is a more efficient and defensible design review process that improves engineering decision-making and supports future digital initiatives.

What Role Do Digital Twins Play in Pharma 4.0™?

Digital twins are playing an increasingly important role in helping pharmaceutical manufacturers connect engineering, operations, and lifecycle decision-making through data-driven insights and simulation.

In "Pharma 4.0™ in Engineering and Operations: Holistic Digital Twins," Peer Sander of INOSIM GmbH and Dennis Meister of Octapharma explore how simulation technologies are being used across plasma manufacturing operations.

The session demonstrates how sophisticated models developed during engineering projects can evolve into digital twin applications that support daily operations. Through real-world examples, attendees will learn how integrated digital solutions can improve transparency, optimize performance, and create measurable value throughout the facility lifecycle.

How Can AI Improve Deviation Management?

Deviation management remains one of the most resource-intensive and quality-critical activities in biopharmaceutical manufacturing.

In "Rewiring Deviation Lifecycle with Intelligence," Serkan Solmaz of UCB presents a generative AI (GenAI)-supported strategy designed to improve investigation quality while maintaining full human ownership of decisions and outcomes.

The presentation examines capabilities including GenAI-assisted deviation authoring, structured root cause analysis using methodologies such as 5 Whys and Fishbone, investigation quality monitoring, and knowledge reuse across deviations and corrective and preventive actions. Rather than functioning as an autonomous decision-maker, GenAI serves as a quality copilot that helps teams work more efficiently while preserving accountability and data integrity.

Why Is Data Governance Essential for Pharma 4.0™ and AI?

Organizations cannot successfully scale AI without trusted data.

In "Data Governance: Launchpad for Pharma 4.0™ and AI in Bio," experts from Roche including Andrea Kurz, Dominik Wendel, and Frank Seibel explore how data governance can bridge evolving regulatory expectations with digital innovation.

The session examines how organizations can navigate requirements associated with EU GMP Chapter 4, Annex 11, and the forthcoming Annex 22 while creating scalable foundations for AI deployment. As pharmaceutical manufacturers move from AI experimentation to broader implementation, robust data governance has become a foundational business capability that supports both compliance and innovation.

How Are Pharma 4.0™ Technologies Advancing Fill-Finish Manufacturing?

Several sessions explore how Pharma 4.0™ technologies are improving biologic drug product manufacturing and aseptic processing operations.

In "Modality-Aligned Pharma 4.0™ Technologies for Biologic Drug Product Manufacturing," Christian Lavarreda of Syntegon and Amit Kumar, PhD, of Wood Group examine how digital twins, AI, process analytical technology, automation, and modular manufacturing approaches can support a range of biologic modalities, including monoclonal antibodies, antibody-drug conjugates, mRNA therapies, oligonucleotides, and viral vectors.

The discussion continues in "Computational Fluid Dynamics (CFD)/AI Modeling for Parenteral Fill Finish Development," where Erick Mattos of Johnson & Johnson and Jiasheng Yang of Bausch+Ströbel SE + Co. KG explore how CFD and AI-driven predictive models can accelerate process development and improve control over fill accuracy.

Attendees interested in workforce performance and operational consistency will also benefit from "Virtual Reality (VR) for Consistent Aseptic Operator Execution," in which Francois Faul of SKAN AG and Tobias Ruof of Realworld One demonstrate how VR-enabled training can improve operator performance, reduce deviations, and support measurable operational improvements.

How Are Robotics Transforming Biopharmaceutical Process Development?

Automation is increasingly influencing activities beyond commercial manufacturing.

In "Modular Robotics for Autonomous Process Development," Nandita Vishwanathan of Merck KGaA explores how integrated robotic platforms are helping organizations accelerate biotechnology process development through workflow standardization, miniaturization, and high-throughput experimentation.

The presentation highlights how end-to-end data integration, platform interoperability, and robust data management can enable faster development cycles, improved reproducibility, and more effective use of laboratory resources while maintaining Quality by Design principles.

Can Pharma 4.0™ Help Scale Cell and Gene Therapy Manufacturing?

Cell and gene therapies continue to present some of the industry's most significant manufacturing and scalability challenges, creating important opportunities for the application of Pharma 4.0™ principles.

In "An Insight into the Future of CAR-T Therapies," Tishwant Kanwarjit of Autolus and Alfred Penfold of PM Group discuss the evolution of ATMP manufacturing and the industry's efforts to improve scalability and patient access.

The track also includes "Is Automation the Missing Link in Cell and Gene Therapy?" where Faryal Khan of CRB examines how selective automation, robotics, and smart manufacturing approaches can help reduce labor intensity and support more sustainable manufacturing models for autologous CAR-T therapies.

Together, these sessions illustrate how digital technologies can help address some of the most complex operational challenges facing advanced therapies today.

Why the Pharma 4.0™ in Action: Biopharma Manufacturing Transformation Track Matters

The Pharma 4.0™ in Action: Biopharma Manufacturing Transformation brings together real-world examples of how digital technologies and Pharma 4.0™ principles are being translated into practice across biologics, aseptic processing, plasma fractionation, and advanced therapies.

Across the sessions, one theme stands out: digital transformation is not simply about introducing new technologies. It is about connecting technology with data, processes, people, and quality systems to address real operational challenges. Through real-world examples from companies including Autolus, Bachem, Eliquent Life Sciences, Johnson & Johnson, Merck KGaA, Novo Nordisk, Octapharma, Roche, Syntegon, UCB, and others, the track explores how AI and advanced analytics, digital twins, robotics, virtual reality, and advanced process modeling are being applied to move from digital ambition to meaningful implementation. The sessions will also highlight implementation strategies, lessons learned, and practical outcomes, offering insights that can be applied to transformation initiatives across the biopharmaceutical manufacturing lifecycle.

Join industry experts and practitioners in Berlin, Germany, or virtually on 10–11 December to explore what Pharma 4.0™ looks like when it moves from strategy into action—and take away practical insights for your own transformation journey.

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