Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Events & Activities
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Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector. -
Thu - Fri, 15 - 16 May 2025
Training
Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors. -
Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector. -
Thu - Fri, 15 - 16 May 2025
Training
Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors. -
Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector. -
Thu - Fri, 15 - 16 May 2025
Training
Join us in person for hands-on training offering unique networking opportunities and real-time problem-solving with peers and instructors. -
Thu, 15 May 2025
Facility Tours
Join us for an exclusive tour of either the Francis Crick Institute or Autolus after the conference. -
Sat - Sun, 10-11 May 2025
International Hackathon
Emerging Leaders, connect with peers in an interactive session to discuss solutions for trending issues in the pharma sector.
All session times are listed in Greenwich Mean Time (GMT). Find your personal viewing time on the World Clock.
Filters
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Virtual
Mon, 12 May
Tue, 13 May
Wed, 14 May
0800 – 0820
0820 – 0850
General Session
Evdokia Korakianiti, EMA
Evdokia will present of the regulatory landscape in EU and how it supports the update of innovation in medicines development manufacturing and control.
0850 – 0920
General Session
Ian Jackson, MHRA
0920 – 0930
1015 – 1045
General Session
Ilaria Lo Presti, GSK
The pharmaceutical industry's shift towards renewable energy is crucial—but are we using these resources as efficiently as possible? This session will explore GSK’s approach to applying AI and data science to optimize energy consumption, reduce carbon footprints, and ensure that sustainability initiatives deliver the benefits that they said they would.
1045 – 1125
General Session
Francesco Intoccia, CSL Behring
Gunter Baumgartner, Takeda Pharmaceuticals International AG
Dave DiProspero, CRB
The 2025 ISPE Facility of the Year Awards (FOYA) celebrate the pharmaceutical industry’s most innovative and technologically advanced facilities that set new benchmarks in efficiency, quality, and sustainability. This year’s category winners exemplify excellence in facility design, operational agility, and cutting-edge advancements that drive the future of pharmaceutical manufacturing. Join us as we announce the 2025 FOYA Category Winners from the 2025 FOYA Submission Finalists who are transforming global healthcare through innovation, collaboration, and a commitment to patient-centric solutions. Learn how these exceptional projects are shaping the future of pharmaceutical engineering!
1125 – 1130
General Session
Heather Watson, TenTenTen Consulting Ltd
1300 – 1500
General Session
Alice Redmond, CAI
Kevin O'Donnell, Health Products Regulatory Authority (HPRA)
Graham Carroll, MHRA
Arie Menachem, Novo Nordisk
The ICH Q9 Guideline, originally issued in 2005, underwent a targeted revision and was republished as ICH Q9(R1) in 2023. This revision addressed four key areas for improvement in the application of Quality Risk Management (QRM):
- High levels of subjectivity in risk assessments and QRM outputs
- Inadequate management of supply and product availability risks
- Lack of understanding of what constitutes formality in QRM
- Unclear guidance on risk-based decision-making
Additionally, two further points were identified for clarification:
- Expectations for maintaining current risk assessments and implementing risk review activities
- Updating the term “risk identification” to the more accurate term “hazard identification”
This workshop will focus on the practical implementation of ICH Q9(R1). We will begin with a presentation from Dr. Kevin O’Donnell, HPRA & ICH Q9(R1) Rapporteur, providing regulatory insights and expectations on the implementation. A key focus area will be on reducing subjectivity in risk assessments and enhancing best practices in risk-based decision-making, using ICH Q9(R1) training materials as a foundation.
Through interactive polls, Q&A sessions, and discussions, we will engage participants on key concerns and challenges. Additionally, we will explore case studies, including applications of new technologies and artificial intelligence, and outline a recommended roadmap for successful ICH Q9(R1) implementation and improvement. These insights will help advance industry adoption of QRM to support sustained manufacturing excellence and defect reduction.
This practical workshop is particularly valuable for QA and Regulatory professionals, offering direct engagement with Regulatory insights and industry case studies. However, individuals from all discipline across the organization will benefit from the practical consideration of how QRM must be implemented across the PQS.
- High levels of subjectivity in risk assessments and QRM outputs
- Inadequate management of supply and product availability risks
- Lack of understanding of what constitutes formality in QRM
- Unclear guidance on risk-based decision-making
Additionally, two further points were identified for clarification:
- Expectations for maintaining current risk assessments and implementing risk review activities
- Updating the term “risk identification” to the more accurate term “hazard identification”
This workshop will focus on the practical implementation of ICH Q9(R1). We will begin with a presentation from Dr. Kevin O’Donnell, HPRA & ICH Q9(R1) Rapporteur, providing regulatory insights and expectations on the implementation. A key focus area will be on reducing subjectivity in risk assessments and enhancing best practices in risk-based decision-making, using ICH Q9(R1) training materials as a foundation.
Through interactive polls, Q&A sessions, and discussions, we will engage participants on key concerns and challenges. Additionally, we will explore case studies, including applications of new technologies and artificial intelligence, and outline a recommended roadmap for successful ICH Q9(R1) implementation and improvement. These insights will help advance industry adoption of QRM to support sustained manufacturing excellence and defect reduction.
This practical workshop is particularly valuable for QA and Regulatory professionals, offering direct engagement with Regulatory insights and industry case studies. However, individuals from all discipline across the organization will benefit from the practical consideration of how QRM must be implemented across the PQS.
1545 – 1645
General Session
Cristina Mazo, Lab. GP-Pharm
Yurii Lebid, Pharmaxi LLC
Heather Watson, TenTenTen Consulting Ltd
Frank Henrichmann, Q-FINITY Quality Management
Jiri Moninec, ISPE Affiliate Czech Republic/Slovakia
Disasters—whether man-made or natural disasters—pose significant threats to patient safety, data integrity, and business continuity. This keynote examines how GxP-regulated companies can prepare for and respond to these challenges, focusing on recent examples such as the war in Ukraine and floods in Spain, and the Czech Republic. We’ll explore the immediate impacts of these events, including disruptions to infrastructure, supply chains, regulated data, and outsourced services, while also addressing their toll on staff through stress, altered working conditions, and personal hardships.
By comparing the predictability, duration, and damage of man-made versus natural disasters, we uncover valuable lessons in risk assessment and mitigation. From anticipating geopolitical crises to understanding the overlooked risks of natural calamities, this session highlights strategies for safeguarding operations, ensuring data integrity, and supporting staff during crises. Attendees will gain actionable insights into building resilient systems that protect patient safety and regulatory compliance in the face of unforeseen events.
This session will feature a panel discussion with presenters from Ukraine, the Czech Republic, and Spain, providing an opportunity to address questions from the audience.
By comparing the predictability, duration, and damage of man-made versus natural disasters, we uncover valuable lessons in risk assessment and mitigation. From anticipating geopolitical crises to understanding the overlooked risks of natural calamities, this session highlights strategies for safeguarding operations, ensuring data integrity, and supporting staff during crises. Attendees will gain actionable insights into building resilient systems that protect patient safety and regulatory compliance in the face of unforeseen events.
This session will feature a panel discussion with presenters from Ukraine, the Czech Republic, and Spain, providing an opportunity to address questions from the audience.
0800 – 0815
General Session
Christopher Reid, ProductLife Group
0815 – 0845
General Session
Rasmus Pedersen, FUJIFILM Diosynth Biotechnologies
Industrializing biologics to dramatically improve patient access with the modular KojoX™ approach.
When it comes to industrialization, biopharmaceutical manufacturing is somewhat different from other industries like automotive or semiconductors. Despite rigorous quality standards, there is a lot of variability in the way we operate and communicate across the entire sector. Each pipeline has its own “touch of magic.” Each company has its own “flavor” in drug recipes and manufacturing approaches, and each manufacturing site has its own installed capabilities. The differences become painfully apparent when scaling up a program, or when we transfer programs from company to company or from one location to another. In the end, those differences can create key bottlenecks when we - as a combined industry – do our best to provide medicines to our clients for their patients.
However, underneath all of the differences there is a common core from which we can industrialize biologics much more. At FUJIFILM Diosynth Biotechnologies, we are pushing industrialization of biologics to the next level, fighting those bottlenecks. Our uniform operating philosophy with modular approach, KojoX, is the framework for our aggressive expansion journey in which we build a global network of process and manufacturing capabilities operating in a uniform way with second-to-none delivery performance across sites, scales, modalities, and drug life cycle phases.
When it comes to industrialization, biopharmaceutical manufacturing is somewhat different from other industries like automotive or semiconductors. Despite rigorous quality standards, there is a lot of variability in the way we operate and communicate across the entire sector. Each pipeline has its own “touch of magic.” Each company has its own “flavor” in drug recipes and manufacturing approaches, and each manufacturing site has its own installed capabilities. The differences become painfully apparent when scaling up a program, or when we transfer programs from company to company or from one location to another. In the end, those differences can create key bottlenecks when we - as a combined industry – do our best to provide medicines to our clients for their patients.
However, underneath all of the differences there is a common core from which we can industrialize biologics much more. At FUJIFILM Diosynth Biotechnologies, we are pushing industrialization of biologics to the next level, fighting those bottlenecks. Our uniform operating philosophy with modular approach, KojoX, is the framework for our aggressive expansion journey in which we build a global network of process and manufacturing capabilities operating in a uniform way with second-to-none delivery performance across sites, scales, modalities, and drug life cycle phases.
0845 – 0915
As long-term bariatric patients and advocates, Paul and Angela are passionate about improving access to a full range of obesity treatments, including recent advances such as injectables. By sharing their lived experiences—including the challenges of accessing care and confronting weight stigma—they aim to shift perceptions and foster greater understanding of obesity as a complex, chronic condition.
0915 – 0930
General Session
1015 – 1045
Biotech: Large Molecules - Cell & Gene - ATMPs
David Phasey, 3P Innovation
The cost-of-goods of autologous therapies is considerably higher than conventional treatments and this creates payment challenges, so that those therapies can be made available to the greatest number of patients. Over the last 10+ years, industry representatives, equipment providers, therapy developers, and consulting firms have sought to analyze the drivers of the cost-of-goods (COGs) for ATMPs to determine how this cost might be reduced. Autologous therapies typically require a significant amount of manual effort from highly skilled and trained operators and this limits scalability and potential benefits due to economies of scale. Automation is recognized as a tool to enable a combination of scalability, reduced manufacturing costs, and increased quality. Members of the ISPE Biotech Automation IT/OT SIG have been evaluating published data to draw conclusions about the state of the industry today and exploring what the development of products in other sectors can tell us about the potential reduction of CoGs can be achieved in the future. In this presentation, members of the SIG will be sharing those findings.
1015 – 1045
Good Engineering Practice - Investment Management
Florian Keferböck, Takeda
Bridging Innovation and Compliance: Covering Annex 1 Requirements and Pharma 4.0 Technologies in a Fast Track Project Approach
The presentation focuses on the intersection between Annex 1 and Pharma 4.0, with a specific emphasis on the innovative Takeda Linz beePFS project. It will begin with an introduction to Takeda and its Linz production site, highlighting the company's values and unique beehive culture. The overview will explain how these values influence the beePFS project, a high-speed initiative aimed at implementing a prefilled syringe filling line to reduce process performance qualification time to 24 months, while incorporating aspects of Pharma 4.0 and updated Annex 1 guidelines. The objective of the beePFS project is to enhance syringe supply security with a dual-source strategy, enabling larger quantities to be supplied quickly and adding in-house syringe filling capabilities to Takeda's aseptic network. The presentation will explore how the updates to Annex 1 and Pharma 4.0 principles impact pharmaceutical manufacturing, showcasing the transformative potential of the beePFS project as a pioneering innovation in the industry. It will address the challenges of integrating new requirements and technologies, the decision-making process for technology selection, and how Takeda leveraged the concept of Pharma 4.0 to ensure a lean, compliant production process within a fast-tracked project timeline.
The presentation focuses on the intersection between Annex 1 and Pharma 4.0, with a specific emphasis on the innovative Takeda Linz beePFS project. It will begin with an introduction to Takeda and its Linz production site, highlighting the company's values and unique beehive culture. The overview will explain how these values influence the beePFS project, a high-speed initiative aimed at implementing a prefilled syringe filling line to reduce process performance qualification time to 24 months, while incorporating aspects of Pharma 4.0 and updated Annex 1 guidelines. The objective of the beePFS project is to enhance syringe supply security with a dual-source strategy, enabling larger quantities to be supplied quickly and adding in-house syringe filling capabilities to Takeda's aseptic network. The presentation will explore how the updates to Annex 1 and Pharma 4.0 principles impact pharmaceutical manufacturing, showcasing the transformative potential of the beePFS project as a pioneering innovation in the industry. It will address the challenges of integrating new requirements and technologies, the decision-making process for technology selection, and how Takeda leveraged the concept of Pharma 4.0 to ensure a lean, compliant production process within a fast-tracked project timeline.
1015 – 1045
Pharma 4.0/Digital Transformation
Luis Miranda, CSL Behring AG
In this session, I will discuss approaches to create and execute a digital transformation roadmap. Using CSL's experiences as a case study, this session will highlight strategies to align enterprise goals with technological trends and overcome resistance to change. We will delve into the importance of strategic alignment and phased implementation, providing you with the tools to develop a comprehensive digital transformation strategy. Explore ways to foster a culture of innovation and proactively address organizational inertia, ensuring your digital initiatives are successful and sustainable. This is aimed at providing valuable insights and practical knowledge that will help others navigate the complexities of digital transformation and drive continuous improvements.
1045 – 1115
Biotech: Large Molecules - Cell & Gene - ATMPs
Andreas Traube, Fraunhofer IPA
With ATLAS (Automated Therapy Production and Lean Automation Suite) Fraunhofer IPA offers a fully automatable solution with equipment operated by robots, and the entire system is housed in a GMP C cleanroom environment with material locks and maintenance access points. To ensure reliable handling of large quantities, handling aids are provided for the robots. The employed 7-axis robots used are equipped with gripper changing systems, allowing complex handling operations to be performed with high reliability. As a second step, we forecast an evolutionary step toward matrix production for cell and gene therapies. This concept allows for scalable, flexible, and decentralized production but requires extensive development in sample carriers or biocapsules. These are incorporated into passive cassettes that can be standardized for handling and have sterile, secure connector systems for interconnecting cassettes. Activation and processing are performed by inserting the cassettes into functional modules. This concept includes extensive in-line quality control and production monitoring.
1045 – 1115
Pharma 4.0/Digital Transformation
Daniel Borchert, Koerber
Damiano Totaro, PhD, Takeda
Digital Transformation is not just an IT project, it causes dramatic changes in many processes within the company and often leads to anxiety for those affected. Well-established routines will be changed, and new systems and approaches will be implemented, which means you must leave your comfort zone and accept new technologies. Digital transformation should make life easier for everyone in the organization. However, the implementation until the relief is noticeable is often associated with enormous effort and resistance. I will talk about which people are involved in the digital transformation, from the CEO to the lab employee, what roles these people have, and what benefits come out of it for everyone. Furthermore, I point out how important it is that the implementation of digital concepts is planned and implemented holistically. It is not enough that the decision is just made by management. The necessary concepts must be implemented to enable the digital transformation.
1045 – 1115
Good Engineering Practice - Investment Management
Ryan O'Sullivan, Eli Lilly
Daniel Breen, Eli Lilly
This presentation is focused on the development of a synthetic peptide manufacturing platform and facility by Eli Lilly Kinsale, Ireland.
The presentation will include an overview of the Kinsale site with a detailed look at the FOYA winning IE2b facility.
The speakers will present on the steps involved in crude peptide synthesis and the use of continuous processing for liquid phase peptide synthesis (LPPS). This will include a breakdown of the individual unit operations and a walkthrough of the equipment, including a description of the nanofiltration technology in use at Kinsale.
This presentation will also give an insight into the importance of digital technology in driving quality and compliance through an industry-first material tracking system.
1115 – 1145
Pharma 4.0/Digital Transformation
Matt Popkin, PhD, GSK
In-silico development of a product and its control strategy (eg models to define shelf life, identify dissolution safe spaces to support specifications and method development, systems models to define process boundaries and identify CPPs and justify parametric controls) and model-based control of the manufacturing process (eg via PAT, or digital-twin process models) are now real world realities. Focus in this area has also been supercharged by the emergence of AI/ML, both as real-world tools and enablers, but also as watchpoints for legislation and regulation.
The speaker will represent the experiences of GSK and EFPIA companies in interactions with the EMA, FDA, and other regulators on the use of modeling in development, and present a vision for how best to deliver pharma 4.0. Points to cover will include:
- Real world examples and experience in justifying the use of models (using examples such as stability modeling, PBBM, design space models, and digital twins)
- A vision for the use of process models in regulatory submissions and manufacturing, including considerations for the framework supporting the use of AI and ML.
- Considerations for the evolution of EU and ICH guidance to enable the use of models
The speaker will represent the experiences of GSK and EFPIA companies in interactions with the EMA, FDA, and other regulators on the use of modeling in development, and present a vision for how best to deliver pharma 4.0. Points to cover will include:
- Real world examples and experience in justifying the use of models (using examples such as stability modeling, PBBM, design space models, and digital twins)
- A vision for the use of process models in regulatory submissions and manufacturing, including considerations for the framework supporting the use of AI and ML.
- Considerations for the evolution of EU and ICH guidance to enable the use of models
1115 – 1145
Biotech: Large Molecules - Cell & Gene - ATMPs
Marco Flori, Staubli Robotic UK
Dan Strange, Cellular Origins
Kevin Vela, Catapult Cell and Gene Therapy
The potential of cell & gene therapies to revolutionize the way we look at disease treatment cannot be understated, offering a route to treat even the most debilitating of conditions. Despite this, insufficient process efficiency, degree of automation, and manufacturing capability have created a significant divide between innovative therapies and the manufacturing capacity we have to make them, ultimately leaving many patients without hope of a cure. The Cellular Origins' robotic platform, Constellation, leverages the power of Staubli's fully autonomous robotic arms, combined with proprietary tube welding, tube sealing, consumable set installation, and fluid transfer technology and integrated into autonomous mobile robotics, to deliver a unique solution for sterile, end-to-end manufacture in a factory setting, bringing space, cost, and labor-efficiency. The system is fully modular and flexible, meaning it can be adopted at any stage of production. Now working in partnership with the Cell and Gene Therapy Catapult, the Companies are exploring the benefits of automation in real-world applications and settings. Automation and robotics will not only make the manufacturing of CGT possible at real scale but will encourage further innovation in CGT development by freeing up therapy developers to focus on bringing more therapies to market and reaching more patients.
1115 – 1145
Good Engineering Practice - Investment Management
Giulio Ripaccioli, GSK Vaccines
Leonardo Zanus, MAASI Enterprises
The pharmaceutical sector is characterized by high complexity and continuous challenges, requiring meticulous risk management to ensure project success. This rapid-fire session aims to emphasize the importance of risk management as an "integral element of good project management practice" [GAMP 5 11.5.3.2] in pharmaceutical projects through real-world experiences and lessons learned. During the session, multiple viewpoints will be presented by two experienced speakers, and several case studies will be presented, highlighting both the effective application of risk management and the consequences of its absence. We will walk through practical examples of how early risk identification and mitigation contribute to achieving project goals or, conversely, how the lack of a proper risk management approach leads to delays, unexpected costs, and failures.
1315 – 1345
Pharma 4.0/Digital Transformation
Luca Zanotti Fragonara, PQE Group
Danilo Neri, PQE Group
Artificial intelligence (AI) covers a broad set of technologies that are increasingly being used across the Life Science Industry to facilitate and govern operations within the Product Life Cycle, including regulated processes such as including drug discovery, development, manufacturing, and regulatory compliance. In this context, Data scientists are now implementing solutions to use the strong capabilities of Generative AI leveraging Large language models (LLM) and natural language processing (NLP) for solutions potentially affecting Patient Safety and Product Quality. This speech addresses several use cases to facilitate and/or automate operations within GxP regulated processes throughout the Product Life Cycle, focusing on a solution to facilitate the management of Quality Records such as Complaints and Deviations. Attendees will gain insights into these practical use cases where AI can streamline the Quality process to reduce operational costs while maintaining regulatory compliance, describing the resulting business benefits and the associated challenges. The speech will also discuss the current regulatory expectations to be met based upon the potential impact of the tool on Product Quality / Patient Safety and the risk reduction capabilities by the human in the loop.
1315 – 1345
Good Engineering Practice - Investment Management
Hazem Eleskandarani, CSL Behring
Mark Drinan, Takeda Pharmaceuticals International AG
Good Engineering Practice and Engineering Quality Processes are fundamental to the design, implementation, and maintenance of a robust Risk Based QRM Commissioning and Qualification process. This delivers on lean qualification concepts, GMP Regulatory impact on project design and implementation, and faster project delivery. The Baseline Guide Volume 5: Commissioning & Qualification 2nd and Edition, 2nd Edition and Good Practice Good Engineering Practice, 2nd Edition are key documents in helping to challenge current C&Q and project delivery methods due to the opportunity cost of missing project delivery deadlines and the impact to patient outcomes. A true quality risk management-based delivery rooted in GEPs and early proactive activities is proven to result in better outcomes.
1315 – 1345
Sustainability
Pierre-Emmanuel Cau, UCB
Alessandro Rosengart, VTU Engineering
The need for increased sustainability of new and old production facilities in the pharmaceutical industry requires a holistic approach to effectively minimize carbon emissions and reduce resource consumption. Yet, it is crucial to maximize the value of capital investments while keeping operating expenditures low. Therefore, it is essential to understand the energy carriers, carbon dioxide, and other material flows within a facility. From a thorough understanding of the current status, an improvement strategy can be defined, utilizing specifically developed tools to assist decision-makers when environmental, economic, and production trade-offs occur. Based on real industrial case studies, options for heat recovery, solvent recycling, and water reuse are presented as part of a techno-economic sustainability strategy for implementation. This strategy compares the investment costs for advanced engineering solutions in operational facilities to changes in operational expenditures, electrical and thermal power use, water consumption, and carbon dioxide emissions.
This approach is being applied in the PharmECO project, a public-private partnership co-funded by the Innovative Health Initiative that is set to integrate sustainability considerations into every phase of pharmaceutical manufacturing. The industrial consortium members belong to the most influential pharmaceutical global players, ensuring a substantial impact on the footprint of the pharmaceutical industry.
This approach is being applied in the PharmECO project, a public-private partnership co-funded by the Innovative Health Initiative that is set to integrate sustainability considerations into every phase of pharmaceutical manufacturing. The industrial consortium members belong to the most influential pharmaceutical global players, ensuring a substantial impact on the footprint of the pharmaceutical industry.
1345 – 1415
Good Engineering Practice - Investment Management
Theresa Ahern, Eli Lilly
Caroline Meenan, BioPhorum
This presentation will, outlines the challenges and opportunities associated with multi-product resin re-use (MRR) in biopharmaceutical manufacturing. It focuses on the benefits of MRR, such as sustainability, cost savings, and faster product turnaround, while acknowledging challenges like cross-contamination and regulatory acceptance. The presentation explores current MRR practices, particularly in early clinical phases, and suggests an analogous approach to multi-product equipment use. Key considerations for implementing MRR will be discussed, including product degradation studies, cleaning cycle optimisation, product carryover analyses, and monitoring resin performance. The Presentation will highlight a risk-based approach to MRR implementation and regulatory considerations, including strategies for incorporating MRR into regulatory dossiers. The overall goal is to provide a framework for routine MRR implementation in clinical and commercial manufacturing through collaboration and discussions with Health Authorities.
1345 – 1415
Pharma 4.0/Digital Transformation
Kenneth Ranzau, OMRON Electronics A/S
Milad Jami, Novo Nordisk
Anders Linneberg, Eltronic A/S
Retrofitting the Autonomous Mobile Robot for Cleanroom Applications in the Pharmaceutical Segment
This initiative is significant as it merges proven technology from various industry segments with a specialized design tailored for cleanrooms. The Robot has established itself as a reliable autonomous mobile robot across several industries, demonstrating versatility and efficiency. In partnership with Eltronic A/S, we have enhanced this technology by incorporating design modifications to ensure compliance with industry standards required in pharmaceutical cleanrooms.
Retrofitting for Cleanroom Applications: Insights into the design modifications to meet cleanroom standards, including materials used and engineering processes involved.
Automation in Cleanroom Environments: Discussing the reduction of contamination risks, improved operational efficiency, and the flexibility offered by AMRs.
Environmental Monitoring Capabilities: Highlight how the integration of AMR can facilitate real-time environmental assessments, ensuring that cleanroom conditions meet regulatory requirements and operational standards.
This initiative is significant as it merges proven technology from various industry segments with a specialized design tailored for cleanrooms. The Robot has established itself as a reliable autonomous mobile robot across several industries, demonstrating versatility and efficiency. In partnership with Eltronic A/S, we have enhanced this technology by incorporating design modifications to ensure compliance with industry standards required in pharmaceutical cleanrooms.
Retrofitting for Cleanroom Applications: Insights into the design modifications to meet cleanroom standards, including materials used and engineering processes involved.
Automation in Cleanroom Environments: Discussing the reduction of contamination risks, improved operational efficiency, and the flexibility offered by AMRs.
Environmental Monitoring Capabilities: Highlight how the integration of AMR can facilitate real-time environmental assessments, ensuring that cleanroom conditions meet regulatory requirements and operational standards.
1345 – 1415
Sustainability
Estelle Darnon, Technip Energies
Integration of Sustainability Objectives on Pharma Project - From Feasibility Stage Until Construction
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
1415 – 1445
Good Engineering Practice - Investment Management
Gwendolyn Foster, Lonza AG
This case study explores how updated Annex 1 guidance was pragmatically applied to a large-scale biopharmaceutical facility already under construction at the time of the 2022 revision. While full implementation was not feasible due to project timing, a structured process closure analysis was used to justify targeted reductions in cleanroom classifications—ensuring alignment with regulatory expectations through scientifically supported decisions.
The presentation details how process understanding, risk-based thinking, and collaboration across disciplines enabled these changes. It also outlines the potential savings identified across construction, operations, labor, and environmental control, and how these insights will inform future facility designs where Annex 1 principles can be embedded from the outset. This is not presented as a definitive model, but rather as one practical example of adapting to evolving regulatory requirements through thoughtful, evidence-based implementation.
1415 – 1445
Pharma 4.0/Digital Transformation
Thomas Hiltbrand, Crypto Pharma
Yacine Haddadi, BD Medical - Phamaceutical Systems
Emilien Folzer, PhD, Ten23 Health AG
The fill/finish stage of pharmaceutical manufacturing is increasingly becoming a critical bottleneck for many companies. Optimizing process efficiency while meeting increasingly stringent regulatory requirements is more crucial than ever. This study demonstrates a novel approach to expanding fill/finish capacity and enhancing quality assurance through unit-level traceability systems using RFID-enabled prefillable syringes. We present a comprehensive analysis of unit-level traceability implementation in parenteral fill/finish operations within GMP environments, addressing both technological benefits and implementation challenges. Our case study on visual inspection processes provides quantitative data comparing conventional methods with RFID-enabled systems, demonstrating measurable improvements in processing time, quality assurance metrics, and operator qualification procedures. Beyond manual visual inspection, this technological advancement serves multiple functions: it provides technical safeguards against batch mix-ups, enhances production efficiency through precise batch segregation during quality incidents and enables automated reconciliation across production stages.
1415 – 1445
This presentation focuses on decarbonization initiatives from a designer perspective. It defines Net Zero Carbon (NZC) and stresses the importance of Whole Life Cycle Assessment (WLCA) in evaluating the environmental impact of facilities throughout their lifecycle. Carbon-saving opportunities are explored for both operational and embodied carbon. Operationally optimizing airflows, lighting, HVAC systems, and commissioning processes are essential strategies. For embodied carbon, recommendations include reusing materials, selecting low-carbon alternatives, reducing waste through off-site fabrication, and applying modular design principles for future adaptability and disassembly. It highlights major carbon emission contributors in building services design, particularly the air change rates in cleanrooms, and shows carbon reductions can be achieved by revisiting the conservative design fundamentals that the industry has relied on in recent decades.
Case studies will demonstrate the successful implementation of NZC principles, such as reducing CO2 emissions by 37% through local material sourcing and design modifications. However, challenges remain, including policy barriers, data gaps, and the need for technological advancements and behavioral changes within the industry. The conclusion emphasizes a comprehensive design approach - LEAN, MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
Case studies will demonstrate the successful implementation of NZC principles, such as reducing CO2 emissions by 37% through local material sourcing and design modifications. However, challenges remain, including policy barriers, data gaps, and the need for technological advancements and behavioral changes within the industry. The conclusion emphasizes a comprehensive design approach - LEAN, MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
1530 – 1600
GAMP
Costanza Stocchi, MAASI Enterprises
Irene Barlacchi, MAASI Enterprises
Francesco Sforazzini, Siena Imaging
The integration of AI/ML foundation models into medical imaging offers significant opportunities for enhancing clinical decision-making. However, it also introduces important compliance challenges, such as adherence to medical device regulations, patient data privacy laws, and the need for transparent model interpretability. Regulatory bodies require that AI/ML models used in healthcare undergo rigorous validation to ensure their safety, efficacy, and applicability across diverse patient populations. Additionally, the use of foundation models raises concerns about algorithmic bias, which could affect diagnostic accuracy and exacerbate healthcare disparities. To explore these challenges, we propose a specialized deep-learning study model for detecting neurodegenerative changes in the human body. This solution is outlined from its initial design through the training phase, along with the proposed validation strategy to ensure robustness, accuracy, safety, and reliability of the results.
1530 – 1600
Good Engineering Practice - Investment Management
Sebastian Scheler, Innerspace GmbH
Jeff Gensler, Kindeva Drug Delivery
Legacy facilities can pose significant risks to product quality, with hidden issues potentially leading to regulatory non-compliance. Companies operating legacy systems face the dual challenge of ensuring safe, reliable operations while adhering to increasingly stringent regulatory standards for modernization and contamination control. This presentation highlights a case study from the Kindeva Fill-Finish Facility in Brentwood, MO where advanced process modeling and risk profiling were employed to substantially reduce risks in legacy processes. For the first time, this study quantifies the risk reduction achieved through these methods, providing a robust framework for evaluating their effectiveness.
The case study features detailed hazard screening of an RABS filling line, which uncovered critical process improvements previously overlooked, resulting in a significantly safer operation. The insights gained also facilitated the technology transfer to state-of-the-art equipment, integrating Quality by Design (QbD) and Quality Risk Management (QRM) principles. A key highlight of the study is the implementation of a fully integrated QRM approach. Utilizing AI, this approach automatically generated essential manufacturing documents - such as MBR, SOPs, training materials, and process overviews - directly from the risk profiling repository. This automation enabled shop floor personnel to manage residual risks more effectively and was supported by a comprehensive surveillance program.
The case study features detailed hazard screening of an RABS filling line, which uncovered critical process improvements previously overlooked, resulting in a significantly safer operation. The insights gained also facilitated the technology transfer to state-of-the-art equipment, integrating Quality by Design (QbD) and Quality Risk Management (QRM) principles. A key highlight of the study is the implementation of a fully integrated QRM approach. Utilizing AI, this approach automatically generated essential manufacturing documents - such as MBR, SOPs, training materials, and process overviews - directly from the risk profiling repository. This automation enabled shop floor personnel to manage residual risks more effectively and was supported by a comprehensive surveillance program.
1530 – 1600
Sustainability
Jean-Francois Fedorenko, GlaxoSmithKline Biologicals
Emilio Moia, Jacobs Italia SpA
The manufacture of sterile products is carried out in a cleanroom, where it must maintain a cleanliness grade compliant with Annex 1. HVAC plays a key role, but on the other end, it means a significant energy cost. The aim of this presentation is to speak about the triggers that influence the HVAC design and the strategies that have been adopted in recent projects to reduce the energy cost of the HVAC, such as: definition of the Air Change based on the contamination source; design for Air Reduction Mode; progress on Adaptive Flow Control, considering the airborne control measurement system; and selection and design of an HVAC System with a low SFP (Specific Fan Power).MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
1600 – 1630
Good Engineering Practice - Investment Management
Gerhard Ortner, PhD, University of Applied Science BFI Vienna
Artificial Intelligence (AI) is transforming project management by enhancing efficiency, accuracy, and decision-making. With its ability to process vast amounts of data, recognize patterns, and generate insights, AI offers significant strengths that can address the challenges of complex projects. In project management, AI is particularly valuable in several key areas, e.g.: Resource Management: AI optimizes resource allocation by analyzing historical and real-time data to forecast personnel, materials, and equipment needs. This ensures efficient utilization and early identification of bottlenecks. Knowledge Management: AI systems streamline access to organizational knowledge by transforming static databases into dynamic, user-friendly tools like conversational AI. This facilitates the retrieval of best practices and lessons learned. Support for Repetitive Tasks: Automating routine activities, such as scheduling, data aggregation, and report generation, frees project teams to focus on strategic decision-making. AI-driven tools create real-time dashboards, offering stakeholders immediate insights into project performance. Controlling, Reporting and Risk Management: By continuously monitoring project progress, AI enhances cost control and schedule adherence through predictive analytics and anomaly detection. Instant reporting capabilities improve transparency and decision-making. AI also extends to quality assurance and communication. Its predictive capabilities enable teams to proactively address potential issues and adapt to dynamic project environments. However, integrating AI demands careful consideration of ethical implications, data privacy, and organizational culture. This presentation will explore practical applications of AI in project management, highlighting how its adoption drives transformative changes across multiple dimensions. Processes will become increasingly automated and data-driven, requiring project teams to adapt to new workflows. Employees will need to develop advanced digital literacy and analytical skills to collaborate effectively with AI systems, while traditional roles in project management will evolve to include oversight of AI tools and interpretation of their outputs. Additionally, the integration of AI will prompt shifts in organizational structures, demanding flexibility and a culture of continuous learning to fully harness the potential of these technologies.
1600 – 1630
Sustainability
Saeed Masoudi, Takeda Pharmaceuticals International AG
The pharmaceutical industry relies heavily on cleanroom environments to ensure the safety and quality of its products. Maintaining proper airflow within these cleanrooms is crucial for minimizing contamination and ensuring product integrity. This presentation aims to provide valuable insights into the most effective approach for simulating airflow in pharmaceutical cleanrooms using CFD and to provide a robust procedure on how the airflow rate should be managed in cleanrooms. An immediate result of the exercise would be a significant decrease in energy consumption of the HVAC system while maintaining regulatory requirements.
1600 – 1630
The objective of the presentation would be to explore the critical role human factors and associated controls (i.e., human-in-the-loop) play in the oversight of AI and machine learning system development. It would aim to highlight the importance of ethical considerations, transparency, and accountability in mitigating potential risks and compliance aspects. By addressing these factors, it will discuss strategies for ensuring that AI systems are designed, developed, and deployed responsibly and in a GxP-compliant manner.
1630 – 1700
GAMP
Martin Heitmann, Independent
Arif Rahman, OPDC
Digital Quality & Validation for Personalized Medicine: AI, Sequencing, and Digital Biomarkers
As the life sciences industry evolves, the integration of AI, sequencing technologies, and digital biomarkers, coupled with strong digital quality and validation processes, is at the forefront of personalized medicine. This proposal explores how these next-generation technologies are transforming healthcare by offering patient-specific treatment plans based on a deeper understanding of disease mechanisms and drug responses, validated for accuracy and compliance.
Personalized medicine, supported by AI and digital biomarkers, requires rigorous validation to optimize drug development processes, ensuring efficacy and safety while maintaining regulatory adherence. Digital quality frameworks play a pivotal role in verifying the accuracy of AI algorithms and ensuring that digital biomarkers meet industry standards. This presentation will focus on two key aspects: the predictive capabilities of AI and the validation strategies that support their implementation in personalized medicines.
Attendees will learn how machine learning models predict adverse reactions, identify actionable biomarkers, and guide clinical decisions, with digital quality ensuring the integrity of these models. Additionally, insights into the validation of real-time data from wearable devices will be provided, showing how these processes contribute to patient-centric care.
As the life sciences industry evolves, the integration of AI, sequencing technologies, and digital biomarkers, coupled with strong digital quality and validation processes, is at the forefront of personalized medicine. This proposal explores how these next-generation technologies are transforming healthcare by offering patient-specific treatment plans based on a deeper understanding of disease mechanisms and drug responses, validated for accuracy and compliance.
Personalized medicine, supported by AI and digital biomarkers, requires rigorous validation to optimize drug development processes, ensuring efficacy and safety while maintaining regulatory adherence. Digital quality frameworks play a pivotal role in verifying the accuracy of AI algorithms and ensuring that digital biomarkers meet industry standards. This presentation will focus on two key aspects: the predictive capabilities of AI and the validation strategies that support their implementation in personalized medicines.
Attendees will learn how machine learning models predict adverse reactions, identify actionable biomarkers, and guide clinical decisions, with digital quality ensuring the integrity of these models. Additionally, insights into the validation of real-time data from wearable devices will be provided, showing how these processes contribute to patient-centric care.
1630 – 1700
Good Engineering Practice - Investment Management
Ryan Farley, NovoNordisk
Christian Siegmund, PhD, F Hoffman-La Roche
Sebastian Faller, F Hoffmann-La Roche AG
Line Lundsberg-Nielsen, NNE
Revolutionizing Pharmaceutical Production: The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in fast expanding production capacity to respond to the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to respond to the dynamic demands of modern healthcare. This paper proposes a novel regulatory framework for Distributed Manufacturing that leverages the concept of "Fleet Management" to address these challenges. Fleet Management involves creating a network of standardized manufacturing facilities that can be efficiently managed and replicated across multiple sites. This approach draws inspiration from the principles of standardization that revolutionized other industries such as automotive manufacturing.
The proposed approach offers significant benefits, including improved regulatory efficiency, reduced drug shortages, and enhanced environmental sustainability. The paper calls for collaboration between regulators and industry stakeholders to refine and implement this innovative framework, paving the way for a more resilient and responsive pharmaceutical manufacturing ecosystem.
The pharmaceutical industry faces significant challenges in fast expanding production capacity to respond to the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to respond to the dynamic demands of modern healthcare. This paper proposes a novel regulatory framework for Distributed Manufacturing that leverages the concept of "Fleet Management" to address these challenges. Fleet Management involves creating a network of standardized manufacturing facilities that can be efficiently managed and replicated across multiple sites. This approach draws inspiration from the principles of standardization that revolutionized other industries such as automotive manufacturing.
The proposed approach offers significant benefits, including improved regulatory efficiency, reduced drug shortages, and enhanced environmental sustainability. The paper calls for collaboration between regulators and industry stakeholders to refine and implement this innovative framework, paving the way for a more resilient and responsive pharmaceutical manufacturing ecosystem.
1630 – 1700
Sustainability
Eilis Kelly, J&J
Alfred Penfold, PM Group
It is not always the case that a more sustainable design can lead to many opportunities such as a reduction in operating cost and associated improvements in productivity and quality. However, the HVAC design is one such opportunity which typically represents anything from 50% to 80% of the total energy consumption of a new facility. The high percentage reflects the stringent requirements for maintaining controlled environments, including temperature, humidity, and air quality that are critical when meeting the Annex 1 requirements for the production and storage of pharmaceutical products. Europe is developing directives to improve the sustainability of facilities and products by incorporating these objectives into their regulations. Learn how to design more sustainable HVAC systems for cleanroom environments that comply with Annex 1.
0830 – 0845
0845 – 0915
General Session
Laura Kuger, Takeda
Teresa Minero, LifeBee | a ProductLifeGroup Company
The Pharma 4.0™ survey in its 8th edition (and its latest deep dive) aim to share the ISPE Pharma 4.0 update on maturity, enabling technology adoption, the benefits, challenges, technical pitfalls and cybersecurity risks around 4.0 from Life Science protagonists. The deep dive of the 8th edition presents an extended analysis, after the first highlight shared in December in Rome, into a few additional intriguing correlations and trends when analyzing current versus previous editions results together with demographics.
0915 – 1015
General Session
Sarah Matson, FFG Group of Companies
Tamara Hamovic, BiggsB
Henal Shah, Persistent Systems Limited
Kate Marshall, Protak Scientific LTD
Join this interactive session, sponsored by Women in Pharma, titled "Workforce of the Future: Challenges and Opportunities."
This session will offer an in-depth exploration of how different generations understand and approach empowering team members. It will examine the impact of various workforce generations within the workplace, strategies for supporting the next generation, and the evolving shift from prioritizing work over personal development. Additionally, we will discuss the importance of soft skills in navigating career progression challenges.
1100 – 1130
Biotech: Large Molecules - Cell & Gene - ATMPs
Elizabeth Goodrich, MilliporeSigma
Evidence of intensified, integrated, and continuous process adoption has increased as the biomanufacturing community drives innovation and advances enabling technologies, although challenges remain in translating from vision to reality for fully connected processing, particularly in the areas of scale-down tools and integrated control. Viral Inactivation is a step in the mAb downstream train where a truly continuous option is lacking. We developed a prototype process-scale inline viral inactivation system (iVI) implementing coiled-flow inverter incubation chambers. The system maintains critical process parameters such as pH and residence time through a combination of PAT and automation. The system employs a residence time distribution (RTD) model built using a large dataset with two different tracer molecules evaluated across multiple chamber scales. We will show implementation of the iVI system for viral inactivation, robustness of the RTD model, a strategy for bench-scale determination of process parameters, and a scale-up demonstration where a multicolumn capture chromatography system was integrated with the iVI system to achieve continuous and connected capture and VI. Key operational parameters, product yield, and mAb quality post-VI were consistent between the bench- and process-scale. Early discussions with Regulators through the FDA ETP and EMA ITF have been instrumental in informing characterization efforts.
1100 – 1130
Pharma 4.0/Digital Transformation
Andrea Kurz, F. Hoffmann-La Roche Ltd in Basel
This presentation gives an overview of the ICMRA's Collaborative Hybrid Inspection Pilot (CHIP) from the Industry's Perspective. The CHIP provides an opportunity to reach an agreement from multiple authorities on the compliance of a site with a single inspection activity. This presentation illustrates a company's journey in preparing, organizing, and hosting a CHIP inspection performed jointly by multiple authorities, being on-site and remotely, under the lead of an on-site inspectorate. The presentation talks about the challenges, opportunities, and benefits of the CHIP. The presentation engages in the conversation on how ultimately such a pilot can further support reliance and convergence efforts amongst regulators.
1100 – 1115
Buildings account for almost 40% of global GHG emissions. This relates to emissions arising from materials of construction and operational emissions such as energy. The global transition to Net-Zero will require decarbonization changes across all elements of society, including the way we design our buildings and manufacture products. Decarbonization strategies for manufacturing facilities, both existing and new build, are essential. To achieve Net-Zero Buildings, the embodied carbon emissions associated with building construction must be reduced. Reducing operational emissions alone will not achieve Net-Zero. Regulatory authorities are recognizing this and introducing legislation for the reporting of whole-life carbon emissions associated with building construction. The revised EU Energy Performance of Buildings Directive puts all European building stock on track to be fully decarbonized by 2050. Further, the Corporate Sustainability Reporting Directive mandates organizations to report their greenhouse gas emissions publicly.
This presentation will provide insight into the source of carbon in pharmaceutical buildings with case study findings on reducing embodied carbon and facility operational carbon emissions. An overview of future regulatory requirements on life cycle assessment for carbon emissions of new buildings will be provided including the challenges & design strategy opportunities required to comply with EU Directives.
This presentation will provide insight into the source of carbon in pharmaceutical buildings with case study findings on reducing embodied carbon and facility operational carbon emissions. An overview of future regulatory requirements on life cycle assessment for carbon emissions of new buildings will be provided including the challenges & design strategy opportunities required to comply with EU Directives.
1115 – 1130
Freeze-drying is an indispensable process in the pharmaceutical and biotech industry, especially in the production of temperature-sensitive products such as biopharmaceuticals and vaccines. Recently, however, the question of sustainability has come more and more into focus, especially with regard to the refrigerants used. In our presentation, we will explain the challenges in the design and implementation of a refrigeration system that uses natural refrigerants. By showcasing an implemented design in a >10 mio. project, we will point out the advantages and pitfalls of such a refrigeration system. Specifically, we will focus on the design of the cooling unit, the choice of the installation site and the involved risk analysis, the security measures e.g. gas detection systems and automatic shut-downs, and the operation of the system.
1130 – 1200
Pharma 4.0/Digital Transformation
Phil Jarvis, VEQTOR Solutions
David O'Connor, No Deviation
Mark Drinan, Takeda Pharmaceuticals International AG
The presentation provides an outline of the new GPG for digital validation that should be drafted by Q4 2024. It discusses how to implement digital validation within an organization effectively, to enable Pharma 4.0, Validation 4.0, data integrity by design, and the creation of efficiencies in the validation processes.
Contents include:
1. Key digital validation concepts- such as how to achieve data integrity by design, and true copy practices with digital validation tools.
2. Creation of business cases for digital validation – by enhancing efficiency and compliance in validation processes, whilst increasing knowledge management.
3. Implementation and governance of digital validation systems - including effective implementation and validation strategies, management of change to a digital validation mindset, and avoid “paper on glass”, data-centric instead of document-centric mentality.
4. Key regulatory considerations – including recommendations for digital validation use in audits, and maintaining robust data integrity.
5. The presentation will also discuss where we are currently with digital validation systems in the industry and future advancements that will ensure a comprehensive digital ecosystem that enables validation 4.0 principles, via integration with other systems, and advanced technologies such as AI/ML.
Contents include:
1. Key digital validation concepts- such as how to achieve data integrity by design, and true copy practices with digital validation tools.
2. Creation of business cases for digital validation – by enhancing efficiency and compliance in validation processes, whilst increasing knowledge management.
3. Implementation and governance of digital validation systems - including effective implementation and validation strategies, management of change to a digital validation mindset, and avoid “paper on glass”, data-centric instead of document-centric mentality.
4. Key regulatory considerations – including recommendations for digital validation use in audits, and maintaining robust data integrity.
5. The presentation will also discuss where we are currently with digital validation systems in the industry and future advancements that will ensure a comprehensive digital ecosystem that enables validation 4.0 principles, via integration with other systems, and advanced technologies such as AI/ML.
1130 – 1200
Biotech: Large Molecules - Cell & Gene - ATMPs
Neil Gamble, PE, Arcadis
With 90% of the IND applications to the FDA failing to make it through clinicals, commercial readiness is sometimes lost to drug development. This presentation will provide insight into how end users can stage drug development for commercial deployment and how project professionals can support the end user with one critical design philosophy: continuous manufacturing (CM). The first half of the presentation will be directed toward pipeline asset owners. It will be demonstrated that [1a] buffer volumes, [1b] process closure, and [1c] scalable equipment can undergo a tweak in pre-clinical that pays dividends in commercial scale - all of which are enabled by CM. The second half will mirror the trajectory of the first by covering the same three topics from the other side of the asset pipeline - engineering design development. Design challenges and CM case studies will be presented from recent biotech projects. Design challenges will include: [2a] In-Line Dilution, [2b] continuous process closure, and [2c] challenges of 92% uptime. The principal case study will be a recent CM project in the US that is able to process one million liters of blood plasma annually at a staggeringly low instantaneous throughput of three liters per minute.
1130 – 1145
Decarbonizing pharmaceutical sites through the use of heat pumps for heat generation involves integrating renewable energy systems to reduce carbon emissions.
1 - Methods: For greenfield sites, the installation of geothermal, water source or air-source heat pumps can be included in the project's design phase, allowing the infrastructure to maximize efficiency. Brownfield sites can be more complex and will require retrofitting heat pumps into existing systems. Key items to consider are examining closely utility load profiles and interfacing with existing systems.
2 - Design Strategies: Optimal design strategies include conducting thorough energy assessments to determine the most efficient heat pump configuration. Integration with other renewable technologies can further enhance energy efficiency. Smart energy management systems can be employed to monitor and adjust Utility heat generators in real-time, ensuring the heat pump operates at peak efficiency.
3 - Benefits: Key benefits include significant reductions in carbon emissions.
1 - Methods: For greenfield sites, the installation of geothermal, water source or air-source heat pumps can be included in the project's design phase, allowing the infrastructure to maximize efficiency. Brownfield sites can be more complex and will require retrofitting heat pumps into existing systems. Key items to consider are examining closely utility load profiles and interfacing with existing systems.
2 - Design Strategies: Optimal design strategies include conducting thorough energy assessments to determine the most efficient heat pump configuration. Integration with other renewable technologies can further enhance energy efficiency. Smart energy management systems can be employed to monitor and adjust Utility heat generators in real-time, ensuring the heat pump operates at peak efficiency.
3 - Benefits: Key benefits include significant reductions in carbon emissions.
1145 – 1200
As sustainability becomes a global priority, the Life Sciences industry faces immense pressure to deliver lifesaving medicines and medical devices faster while working toward Net Zero goals. This necessitates innovative thinking to replace traditional practices with creative production approaches, essential for future-proofing business models and driving positive industry change. Fortunately, sustainability efforts benefit from government and supranational support, as well as the push for digitalization. Digital solutions provide a strategic pathway for sustainability, focusing on energy efficiency, waste reduction, and cleaner operating models. By adopting digital tools, businesses can make granular refinements, leading to significant efficiency gains over time.
This presentation will explore the compelling business case for sustainability and demonstrate how the digital thread's "seamless flow of data and processes throughout the value chain” enables sustainability initiatives. Integrating digital technologies allows businesses to optimize energy consumption, reduce resource waste, and enhance operational efficiency. Digital technology plays a transformative role in achieving net-zero goals, enhancing operational efficiency, and driving long-term growth while minimizing environmental impact.
This presentation will explore the compelling business case for sustainability and demonstrate how the digital thread's "seamless flow of data and processes throughout the value chain” enables sustainability initiatives. Integrating digital technologies allows businesses to optimize energy consumption, reduce resource waste, and enhance operational efficiency. Digital technology plays a transformative role in achieving net-zero goals, enhancing operational efficiency, and driving long-term growth while minimizing environmental impact.
1200 – 1230
Pharma 4.0/Digital Transformation
Mo Behbahani, Eli Lilly Italia SpA
In an era of rapid technological advancements, the pharmaceutical industry is undergoing a transformative shift by integrating artificial intelligence (AI) and advanced data analytics into drug product manufacturing. This presentation explores the potential of these technologies to drive operational excellence, streamline production processes, and enhance product quality. AI and data analytics offer unprecedented opportunities for predictive maintenance, real-time monitoring, and optimization of manufacturing processes. By harnessing large datasets and machine learning algorithms, manufacturers can identify patterns, predict outcomes, and make informed decisions that reduce downtime, minimize waste, and ensure compliance with regulatory standards. This integration not only improves efficiency but also accelerates the time-to-market of new medicines, ultimately benefiting patients through faster access to innovative therapies. This presentation delves into case studies and practical applications in embracing this digital transformation. Through collaborative efforts and continuous innovation, AI and advanced data analytics are poised to redefine how we drive operational excellence in drug product manufacturing.
1200 – 1230
Biotech: Large Molecules - Cell & Gene - ATMPs
Pat Murphy, Eli Lilly
Brian Bosso, STERIS
Biopharmaceutical manufacturers rely heavily on total organic carbon (TOC) testing to confirm the cleanliness of equipment surfaces potentially leading to false positives and problematic on-line or off-line testing programs. Spectroscopy methods such as UV can be used for continuous, in-line monitoring of the cleaning process. Other spectroscopy methods such as FTIR, RAMAN, and fluorescence can be used throughout the cleaning validation lifecycle to assist in residue identification and the development of preventive maintenance procedures. This presentation will include applied laboratory models as well as several case studies to better understand and incorporate spectroscopy analytical methods to your cleaning validation program and complement existing technologies.
1200 – 1230
Sustainability
Michael Keohane, PM Group
Dominik Hof, OPTIMA Pharma GmbH
Brian McKnight, PM Group
Rodrigo Alves, Rockwell Automation
Join us for an engaging session where participants will have the opportunity to ask questions about the four case studies presented. This forum is designed to foster dynamic discussions, allowing the presenters to delve deeper into the topics, share insights, and challenge perspectives in a collaborative environment.
1400 – 1415
Description Coming Soon!
1415 – 1445
General Session
Kirsty Reid, EFPIA
The EU has undergone substantial legislative change driven by the green agenda. While industry supports the overall objective behind those policies, legislative requirements have come in quick succession by the EU legislators. These will have notable cumulation and increased interconnectivity with the pharma agenda. This interlinkage makes it confusing for innovators and regulators to navigate the landscape with the multiple interplays and moving targets. Moreover, the implementation is set to occur simultaneously, creating uncertainty and with tight timelines. This poses a significant challenge for the already highly regulated pharmaceutical sector, potentially leading to unintended negative consequences on the availability of medicines to patients as well as on the sustainability and competitiveness of Europe’s pharmaceutical and healthcare sector. The presentation will give an overview of these identified impacts and discuss recommendations to be taken further by industry and EU decision makers.
1445 – 1630
General Session
Mark Birse, Parexel
Christina Meissner, AGES - Austrian Agency for Health and Food Safety
Ian Jackson, MHRA
David Churchward, AstraZeneca
Brendan Cuddy, EMA
Shaping Tomorrow's Pharmaceutical Framework: Embracing Digital Transformation and Technology in an Evolving Landscape
This dynamic panel discussion brings together leading European Medicines Agencies to explore the rapidly evolving landscape of pharmaceutical regulation in the digital age. As the industry embraces new technologies and data-driven approaches, regulators face both challenges and opportunities in ensuring patient safety, product quality, and regulatory compliance.
The panel will delve into key areas shaping the future of pharmaceutical oversight, including data management strategies, regulatory vision, future regulatory collaboration and impact of AI/ML on Pharmaceutical Regulation
This dynamic panel discussion brings together leading European Medicines Agencies to explore the rapidly evolving landscape of pharmaceutical regulation in the digital age. As the industry embraces new technologies and data-driven approaches, regulators face both challenges and opportunities in ensuring patient safety, product quality, and regulatory compliance.
The panel will delve into key areas shaping the future of pharmaceutical oversight, including data management strategies, regulatory vision, future regulatory collaboration and impact of AI/ML on Pharmaceutical Regulation
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.