Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Events & Activities
-
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 Central European Time (CET). Find your personal viewing time on the World Clock.
Filters
Mon, 12 May
Tue, 13 May
Wed, 14 May
Thu, 15 May
0700 – 0830
Networking
0800 – 0820
0820 – 0850
0850 – 0920
0920 – 0930
0930 – 1015
Networking
On Monday, 12 May and Tuesday, 13 May from 0950-1000, stop by and listen to the Spotlight Session at the ISPE tabletop. The topic of the talk will highlight the new ISPE GAMP® Guide: Artificial Intelligence coming in 2025.
0930 – 1830
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
1130 – 1300
Networking
1300 – 1500
Workshops
Estelle Darnon, Technip Energies
Ester Barle, PhD, Takeda
Louise Loughran, Eli Lilly
Kirsty Reid, EFPIA
Michaela Fuetsch, F. Hoffmann-La Roche AG
Matt Popkin, PhD, GSK
ISPE will organize a workshop on Substances of Concern and Sustainability at the 2025 ISPE Europe Annual Conference in London—a highly relevant topic within the pharmaceutical industry and ISPE.
In this workshop, attendees will take a deep dive into the potential impact of the European Commission's proposed PFAS ban. Additionally, the session will explore the implications of TiO₂ and EthO regulations.
The workshop will feature presentations from various companies and organizations (e.g., Takeda, Roche, EFPIA, and GSK) to provide a holistic view of the current challenges. EFPIA and ISPE have already collaborated on this topic, providing feedback to the European Commission (EC), and in 2023, ISPE launched a survey to assess companies' understanding of the potential impact of upcoming regulations.
Engaging discussions between attendees and speakers will help deepen knowledge, address concerns, and foster an open dialogue on how these product restrictions could affect the pharmaceutical industry. Are alternative solutions available? These key questions will be explored through an enhanced Q&A session designed to facilitate comprehensive discussions.
This workshop is part of Track 1: Sustainability, which addresses the multiple topics and challenges associated with this evolving field.
In this workshop, attendees will take a deep dive into the potential impact of the European Commission's proposed PFAS ban. Additionally, the session will explore the implications of TiO₂ and EthO regulations.
The workshop will feature presentations from various companies and organizations (e.g., Takeda, Roche, EFPIA, and GSK) to provide a holistic view of the current challenges. EFPIA and ISPE have already collaborated on this topic, providing feedback to the European Commission (EC), and in 2023, ISPE launched a survey to assess companies' understanding of the potential impact of upcoming regulations.
Engaging discussions between attendees and speakers will help deepen knowledge, address concerns, and foster an open dialogue on how these product restrictions could affect the pharmaceutical industry. Are alternative solutions available? These key questions will be explored through an enhanced Q&A session designed to facilitate comprehensive discussions.
This workshop is part of Track 1: Sustainability, which addresses the multiple topics and challenges associated with this evolving field.
Estelle Darnon
Head Life Sciences Process Department
Technip Energies
Technip Energies
Ester Barle, PhD
Head of Product Sustainability and Stewardship
Takeda
Takeda
Louise Loughran
Senior Advisor - Chemicals Management
Eli Lilly
Eli Lilly
Kirsty Reid
Director, Science Policy
EFPIA
EFPIA
Michaela Fuetsch
F. Hoffmann-La Roche AG
Matt Popkin, PhD
Senior Director, CMC Excellence
GSK
GSK
1300 – 1500
Workshops
Martin Heitmann, D-fine GmbH
Kevin Bailey, MHRA
Frank Henrichmann, Q-FINITY Quality Management
Brandi Stockton, The Triality Group, LLC
Paige Kane, Saige Digital & Quality Transformations
Workshop “Digital Transformation and GAMP: Implementing an AI Solution in a Pharma 4.0 Context”
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
Integrating innovative AI solutions serves as a cornerstone in the transition toward data-driven organizations and digital transformation. At the same time, ensuring patient safety, maintaining, and achieving regulatory compliance remain priorities within GxP-regulated areas. Examples of Pharma 4.0 principles and GAMP® concepts help in achieving these goals, where specific maturity assessments and risk management techniques have been established for application in an AI context.
This interactive workshop delves into practical aspects of implementing AI in a GxP-regulated environment, guided by the principles and guidance established in ISPE Pharma 4.0® and GAMP®. Participants will explore maturity assessment techniques to evaluate organizational readiness for digital transformation, focusing on critical factors such as infrastructure, culture, and existing processes. They will also have the chance to explore a comprehensive risk assessment methodology tailored to AI solutions, focusing on methods for identifying and mitigating risks to patient safety, data integrity, and product quality.
Through real-world examples and hands-on exercises, attendees will gain actionable insights into aligning AI implementation with digitization objectives while fulfilling quality expectations and adhering to regulatory requirements.
1300 – 1500
Workshops
Maria Amaya, PhD, Genentech, A Member of the Roche Group
Vanessa Bennett, European Medicines Agency
Jean-François Duliere, ISPE
ISPE is organizing a workshop on Drug Shortages Prevention—a critical topic for the industry and all stakeholders in the pharmaceutical world, including regulators.
The workshop will address drug shortages from the perspective of Cultural Excellence. ISPE is currently revising its GAP Assessment Tool, based on the 12 domains outlined in the new Drug Shortage Prevention Model. During the workshop, attendees will gain insights into the progress of this initiative.
Additionally, ISPE is pleased to confirm the participation of the European Medicines Agency (EMA) in this workshop. Attendees can expect valuable insights into EMA's approaches to improving drug shortage prevention and communication.
Through participation, attendees will develop a deeper understanding of the GAP Assessment Tool, its value to the industry as a whole, and how it can support global drug shortage prevention
The workshop will address drug shortages from the perspective of Cultural Excellence. ISPE is currently revising its GAP Assessment Tool, based on the 12 domains outlined in the new Drug Shortage Prevention Model. During the workshop, attendees will gain insights into the progress of this initiative.
Additionally, ISPE is pleased to confirm the participation of the European Medicines Agency (EMA) in this workshop. Attendees can expect valuable insights into EMA's approaches to improving drug shortage prevention and communication.
Through participation, attendees will develop a deeper understanding of the GAP Assessment Tool, its value to the industry as a whole, and how it can support global drug shortage prevention
1300 – 1500
Workshops
Francesca Grattarola, Lilly
This workshop aims to bring together industry leaders and digital transformation champions to explore the latest advancements and strategies in the pharmaceutical sector. The agenda is structured into three key parts:
Part 1: Digital Transformation Champions:
Representatives from leading pharmaceutical companies will share their insights on digital transformation. This session will provide an overview of innovative approaches and strategies being implemented across the industry, setting the stage for a deeper exploration of digital transformation. Some additional areas to be discussed include the business drivers and capabilities, how to navigate the high costs, what are the challenges, what are problems that digital solutions can support.
Part 2: Interactive Panel Discussion with Digital Transformation Champions:
This next session will feature an engaging dialogue between our Digital Transformation Champions. The panel will delve into the challenges and opportunities of digital transformation, fostering a collaborative environment for knowledge exchange and highlighting innovative solutions that drive progress. Questions will be asked such as “Who was the sponsor of the digital transformation initiative”.
Part 3: Interactive Discussion with Audience:
This highly interactive session will focus on identifying the critical success factors for implementing digital transformation initiatives. Participants will engage in discussions on practical approaches, such as determining the most suitable program sponsors or initiators within their organizations (e.g., CIO, CDO, Digital Technologies Leader). Additionally, the session will cover strategies for achieving these goals, sharing valuable tips and lessons learned. Emphasis will be placed on achieving success and driving innovation, while navigating the challenges associated with digital transformation journeys, such as CAPEX and OPEX costs, workforce considerations, and other potential obstacles or challenges.
Join us for an insightful and dynamic workshop that promises to equip you with the knowledge and tools to navigate the evolving landscape of digital transformation and driving innovation in the pharmaceutical industry.
Part 1: Digital Transformation Champions:
Representatives from leading pharmaceutical companies will share their insights on digital transformation. This session will provide an overview of innovative approaches and strategies being implemented across the industry, setting the stage for a deeper exploration of digital transformation. Some additional areas to be discussed include the business drivers and capabilities, how to navigate the high costs, what are the challenges, what are problems that digital solutions can support.
Part 2: Interactive Panel Discussion with Digital Transformation Champions:
This next session will feature an engaging dialogue between our Digital Transformation Champions. The panel will delve into the challenges and opportunities of digital transformation, fostering a collaborative environment for knowledge exchange and highlighting innovative solutions that drive progress. Questions will be asked such as “Who was the sponsor of the digital transformation initiative”.
Part 3: Interactive Discussion with Audience:
This highly interactive session will focus on identifying the critical success factors for implementing digital transformation initiatives. Participants will engage in discussions on practical approaches, such as determining the most suitable program sponsors or initiators within their organizations (e.g., CIO, CDO, Digital Technologies Leader). Additionally, the session will cover strategies for achieving these goals, sharing valuable tips and lessons learned. Emphasis will be placed on achieving success and driving innovation, while navigating the challenges associated with digital transformation journeys, such as CAPEX and OPEX costs, workforce considerations, and other potential obstacles or challenges.
Join us for an insightful and dynamic workshop that promises to equip you with the knowledge and tools to navigate the evolving landscape of digital transformation and driving innovation in the pharmaceutical industry.
1300 – 1500
General Session
Kevin O'Donnell, Health Products Regulatory Authority (HPRA)
Graham Carroll, MHRA
1500 – 1545
Networking
1545 – 1645
General Session
Cristina Mazó, 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.
1645 – 1830
Networking
0700 – 0830
Networking
0700 – 1630
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.
0915 – 0930
General Session
0930 – 1015
Networking
On Tuesday, 13 May from 0950-1000, stop by and listen to the Spotlight Session at the ISPE tabletop. The topic of the talk will highlight the new ISPE GAMP® Guide: Artificial Intelligence coming in 2025.
0930 – 1530
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
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.
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
Nearly three years since the publication of GAMP 5 Second Edition it is an appropriate time to explore how GAMP 5 Second Edition has assisted companies in achieving high quality and effective computerized systems, what many further opportunities are available, and also some of the challenges that remain.
1015 – 1045
Many companies are actively implementing change programs to address sustainability, climate, and environmental programs for medicinal products. Examples include the use of recycled or PVC-free materials in packaging, recycling solvents, c changes to sterile product manufacture, reduction in PFAS use, the replacement of F-gases, and new green synthetic chemistry processes. Significant programs of change bring risks to supply of medicines when implemented without a clear overarching strategy, developed collaboratively between industry and medicines regulators. As such, industry believes that support for innovation in the implementation of change programs for medicinal products is essential to enable medicines suppliers to meet goals for product safety, access, sustainability, climate and the environmental.
This session will explore how innovation in product design and manufacturing can deliver for medicines manufacturing & explore how alternative CMC regulatory tools and approaches, based on principles of science & risk used to enable rapid access to medicines, can enable the transformation of medicines and manufacture. The session will also look at how the modernization of the variations framework and reliance enable change. The session will reference positions of ISPE, EFPIA and EMA on enabling sustainability in product design and manufacturing and use EFPIA companies examples of sustainability change programs.
This session will explore how innovation in product design and manufacturing can deliver for medicines manufacturing & explore how alternative CMC regulatory tools and approaches, based on principles of science & risk used to enable rapid access to medicines, can enable the transformation of medicines and manufacture. The session will also look at how the modernization of the variations framework and reliance enable change. The session will reference positions of ISPE, EFPIA and EMA on enabling sustainability in product design and manufacturing and use EFPIA companies examples of sustainability change programs.
1045 – 1115
Sustainability
Mirella Miettinen, PhD, University of Eastern Finland
We have systematically analyzed EU chemicals policy and legislation to detect relevant initiatives and concrete changes to chemicals legislation. We identified nearly 40 concrete changes to EU chemicals legislation that could have an impact on the pharmaceutical industry or other actors in the pharmaceutical sector. These comprise amendments to the REACH Regulation, including the proposed restriction on PFASs, amendments to the CLP Regulation, restrictions on certain substances (such as titanium dioxide), changes to EU water and industrial emissions legislation, new requirements for packaging and sustainable products, an obligation to exchange data between EU agencies, and more comprehensive sustainability reporting and due diligence requirements.
We have also examined how these changes to EU chemicals legislation are reflected in EU pharmaceutical policy and legislation and related guidance documents, as well as in position papers and other documents produced by the pharmaceutical industry, interest groups, and other stakeholders. In addition, semi-structured interviews have been conducted to explore how different actors (5 pre-defined groups) in the pharmaceutical sector perceive changes in EU chemicals policy and legislation and whether these changes may have influenced the practices and measures taken toward green transformation. The preliminary results of the interviews with the pharmaceutical industry will be presented.
We have also examined how these changes to EU chemicals legislation are reflected in EU pharmaceutical policy and legislation and related guidance documents, as well as in position papers and other documents produced by the pharmaceutical industry, interest groups, and other stakeholders. In addition, semi-structured interviews have been conducted to explore how different actors (5 pre-defined groups) in the pharmaceutical sector perceive changes in EU chemicals policy and legislation and whether these changes may have influenced the practices and measures taken toward green transformation. The preliminary results of the interviews with the pharmaceutical industry will be presented.
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
GAMP
Brendan Walshe, Integrity Solutions
Christopher Reid, ProductLife Group
Taking an in-depth look at ISPE GAMP 5 Second Edition, A Risk Based Approach to Compliant GxP Computerized Systems [1], section 2.1.4. How critical thinking, when applied correctly, removes common mistakes. Establish some common sense principles of risk management when applying to different types of Computerized Systems, from ERP to GAMP category 3 systems. This presentation will address common mistakes that practitioners may currently be making around Functional Risk Assessments.
1045 – 1115
Good Engineering Practice - Investment Management
Ryan O'Sullivan, Eli Lilly
Daniel Breen, Eli Lilly
Description Coming Soon!
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.
1115 – 1145
Sustainability
Bob Brooks, PhD, Biophorum
Victoria Mwanza, BioPhorum
Navigating Regulatory and Government Body Challenges: BioPhorum's Collaborative Approach to Managing Materials of Concern
The Material of Concern Workstream, initiated by BioPhorum, addresses the regulatory and environmental challenges posed by materials of concern such as PFAS, EtO, and Triton X 100. This initiative emerged as a result of a number of industry consultations led by the European Chemicals Agency (ECHA) and the US Environmental Protection Agency (EPA), which highlighted the significant impact of proposed changes on the biopharma sector. The workstream aims to enhance understanding and management of these materials through a collaborative approach involving various teams and communicating closely with the relevant regulatory and government bodies.
The workstream is divided into two teams:
1. Reactive Team, which responds to current materials of concern, these teams have submitted a number of regulatory responses to agencies as well as collaborated with FDA, EPA, ECHA, BARDA, US centre and congress etc through a number of face-to-face or online meetings
2. The Proactive Team establishes systems to handle new potential concerns. The proactive process involves capturing material alerts, evaluating impacts, assessing industrial implications, and engaging with regulatory bodies during consultation periods. The ultimate goal is to position biopharmaceutical manufacturing as a globally recognized 'Use Case' that warrants attention from regulatory agencies.
The team ultimately wish to foster an environment where process and collaboration is in place in order to ensure that the proposed standards protect both environmental and public health without compromising the availability of critical biological products.
The Material of Concern Workstream, initiated by BioPhorum, addresses the regulatory and environmental challenges posed by materials of concern such as PFAS, EtO, and Triton X 100. This initiative emerged as a result of a number of industry consultations led by the European Chemicals Agency (ECHA) and the US Environmental Protection Agency (EPA), which highlighted the significant impact of proposed changes on the biopharma sector. The workstream aims to enhance understanding and management of these materials through a collaborative approach involving various teams and communicating closely with the relevant regulatory and government bodies.
The workstream is divided into two teams:
1. Reactive Team, which responds to current materials of concern, these teams have submitted a number of regulatory responses to agencies as well as collaborated with FDA, EPA, ECHA, BARDA, US centre and congress etc through a number of face-to-face or online meetings
2. The Proactive Team establishes systems to handle new potential concerns. The proactive process involves capturing material alerts, evaluating impacts, assessing industrial implications, and engaging with regulatory bodies during consultation periods. The ultimate goal is to position biopharmaceutical manufacturing as a globally recognized 'Use Case' that warrants attention from regulatory agencies.
The team ultimately wish to foster an environment where process and collaboration is in place in order to ensure that the proposed standards protect both environmental and public health without compromising the availability of critical biological products.
1115 – 1145
As the pharmaceutical industry advances towards greater automation and efficiency, the integration of digitalized project execution tools is essential for optimizing project outcomes. This presentation will explore the assessment and implementation of software tools in line with GAMP5 2nd Edition guidelines, focusing on supplier project execution systems and their potential benefits.
We will cover:
- The evaluation of supplier execution tools and their impact on time, cost, consistency, and quality.
- Innovations in automated design-to-code processes and smart commissioning, highlighting efficiency gains.
- Future enhancements through AI for code validation and automated testing.
- Lessons from suppliers using customer-owned platforms, like Kneat and QALM, and the challenges of technical and workflow alignment.
- Key strategies for integrating these tools into Project Validation Strategies, including supplier engagement, role clarity, and validation workshops.
We will cover:
- The evaluation of supplier execution tools and their impact on time, cost, consistency, and quality.
- Innovations in automated design-to-code processes and smart commissioning, highlighting efficiency gains.
- Future enhancements through AI for code validation and automated testing.
- Lessons from suppliers using customer-owned platforms, like Kneat and QALM, and the challenges of technical and workflow alignment.
- Key strategies for integrating these tools into Project Validation Strategies, including supplier engagement, role clarity, and validation workshops.
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 - Rosia, IT
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.
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
1145 – 1315
Networking
1315 – 1345
Biotech: Large Molecules - Cell & Gene - ATMPs
Jon Halling, Catapult Cell and Gene Therapy
Alfred Penfold, PM Group
ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as 'Personalised Medicines'. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived compounds (small molecule), or proteins or peptides expressed as cellular systems (large molecule). It is not surprising that there are regulations and guidance specifically for ATMPs such as EudraLex Volume 4, Part IV (EMA), and PIC/S Annex 2A. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines with the ATMP sector not always clear on the regulatory expectations. Learn how to navigate through some of these differences including when and how to apply EudraLex Annex 1 (Manufacture of Sterile Medicinal Products), ICH Q9 (Quality Risk Management), and ICH Q5 (viral safety evaluation).
1315 – 1345
GAMP
Chris Kenny, JDI Digital Transform LTD
Paul Irving, Northern Life Sciences Ltd.
Applying GAMP 5 Second Edition Key Concepts to Enable a Successful Health Cloud Platform Implementation
A Case Study, detailing how we utilized GAMP 5 Second Edition to help a leading Life Sciences Organization Implement and Validate the following Health Cloud Platform, a description of functionality and capabilities are detailed below.
- Health Cloud (HC) is a modular platform built on Technology contextualized for the Health and Life Sciences sector.
- It allows the organization to connect Hospitals, Nurses, Patient Services, and Pharmacy with our Patients through a series of Cloud Services:
- Health Cloud CRM – Manages the Patient Record and is the central view of the patient's needs: Assets, Regimens, Stock Levels, Prescriptions etc.
- Communities – Enables connection via the HCP Portal (for patient referrals and ongoing communications) and Patients (for day-to-day contact within the organization) via the Patient Portal.
- Application Field Service – Enables Field Based care through efficient high-volume route planning and patient-facing treatment management.
- All the above sits within a Life Sciences Organization that can be expanded to other business units.
A Case Study, detailing how we utilized GAMP 5 Second Edition to help a leading Life Sciences Organization Implement and Validate the following Health Cloud Platform, a description of functionality and capabilities are detailed below.
- Health Cloud (HC) is a modular platform built on Technology contextualized for the Health and Life Sciences sector.
- It allows the organization to connect Hospitals, Nurses, Patient Services, and Pharmacy with our Patients through a series of Cloud Services:
- Health Cloud CRM – Manages the Patient Record and is the central view of the patient's needs: Assets, Regimens, Stock Levels, Prescriptions etc.
- Communities – Enables connection via the HCP Portal (for patient referrals and ongoing communications) and Patients (for day-to-day contact within the organization) via the Patient Portal.
- Application Field Service – Enables Field Based care through efficient high-volume route planning and patient-facing treatment management.
- All the above sits within a Life Sciences Organization that can be expanded to other business units.
1315 – 1345
Pharma 4.0/Digital Transformation
Graham Upton, Capgemini
When it comes to smart manufacturing for the pharmaceutical industry the objectives are clear. It is about empowering people to make effective decisions and generating bottom-line value. In manufacturing it is mainly about improving yield and productivity which from an asset care perspective means mainly:
- Improve Asset Utilization and Uptime
- Improve Equipment Reliability
This Proof of Value showcases how our combined solution empowers GSK to proactively address asset maintenance issues, ultimately minimizing production downtime and costs. The integrated platform using Cognite Data Fusion, Autodesk BIM model, SAP, Mendix Connectors and Artificial Intelligence, provides field engineers with asset data including Piping and Instruction Diagrams (P&ID's), instructions manuals, images, SAP work orders, etc.). This enables rapid troubleshooting, informed decision-making, and streamlined maintenance execution. The solution promotes efficiency, safety, and cost reduction for GSK's production operations.
- Throughout the duration of this project, significant insights, explorations, and opportunities have surfaced, enriching our comprehension of GSK's data sources, business processes, and the integration of cutting-edge technologies within the GSK ecosystem.
- Improve Asset Utilization and Uptime
- Improve Equipment Reliability
This Proof of Value showcases how our combined solution empowers GSK to proactively address asset maintenance issues, ultimately minimizing production downtime and costs. The integrated platform using Cognite Data Fusion, Autodesk BIM model, SAP, Mendix Connectors and Artificial Intelligence, provides field engineers with asset data including Piping and Instruction Diagrams (P&ID's), instructions manuals, images, SAP work orders, etc.). This enables rapid troubleshooting, informed decision-making, and streamlined maintenance execution. The solution promotes efficiency, safety, and cost reduction for GSK's production operations.
- Throughout the duration of this project, significant insights, explorations, and opportunities have surfaced, enriching our comprehension of GSK's data sources, business processes, and the integration of cutting-edge technologies within the GSK ecosystem.
1315 – 1345
Sustainability
Alessandro Rosengart, VTU Engineering
Jérémie Dutot, UCB
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.
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.
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.
1345 – 1415
Biotech: Large Molecules - Cell & Gene - ATMPs
Michael Vrijis, Incyte Biosciences
In today’s commercial climate, biopharmaceutical manufacturing facilities are pushed to produce more while reducing costs, be more sustainable, reduce the time for product changeover and new product introduction. Equipment cleaning optimization can play a major role to achieve these goals. Historically, companies used to focus just on whether the equipment is clean to produce the next batch. Not much attention was given to optimization. Now, through knowledge and experience, equipment cleaning operations can be streamlined in such a way that costs are reduced and speed, agility and sustainability are increased without endangering quality. Additionally, through a risk-based approach, cleaning validation activities can be reduced to minimize the impact on production schedules. This presentation will discuss the different possibilities to improve equipment cleaning operations and validation activities, and go into detail for the cleaning of empty chromatography columns and packing equipment. Providing a justification for using in-process controls instead of cleaning validation.
1345 – 1415
GAMP
Carsten Jasper, Charles River Laboratories Inc
Most laboratories have to deal with legacy laboratory systems that do not fulfill current regulatory and data integrity expectations. These systems often use inefficient hybrid paper-based mitigations or pose high risks to the integrity of data. Additionally, those systems slow down digital transformation. Based on a use case this presentation will showcase a potential solution for such systems. This solution is LabMonitor from CIMCON Software. After a short introduction of the use case (a digital transformation project for a mid-size laboratory), the software and its main features will be explained, and based on the practical aspects the potential of such software will be showcased. Another focus will be on points to consider when such a solution is being used for digital transformation and improvement of data integrity.
1415 – 1445
GAMP
Thomas Makait, MTP4Pharma® - Intrinsic Plug & Operate Compliance
Markus Fink, Siemens AG, DI PA PHA
In past years, the pharmaceutical industry increasingly perceived their manufacturing facilities as being too static and inflexible. Shorter time to market and faster changeover times raised the need for new concepts. Modularization and standardization in plant engineering, as well as automation and operations, paved the way and resulted in the concept of standardized Module Type Package (MTP). To compliantly and efficiently implement the new MTP concept in modular plants, the Global GAMP Special Interest Group for Qualification and Validation of Modular Plants was founded, and some of the working results will be presented. The objective is to present a holistic data-driven and integrated approach to the qualification and validation of such plants. This standardized approach will be the basis for delivering compliant modular plants as efficiently as possible, ideally starting already during the very early end of process development and early engineering phases. Inherent elements of a modular plant are Process Equipment Assemblies (PEAs), previously called package units or skids, and a superior Process Orchestration Layer, the so-called POL. These two levels communicate with each other via a standardized MTP interface.
1415 – 1445
Biotech: Large Molecules - Cell & Gene - ATMPs
Paul Osborne, BioPhorum
Stephanie Whitmore, Eli Lilly & Company
Aateka Sultana, Boehringer Ingelheim
BioPhorum members have been discussing how Annex 1 can be applied in low-bioburden biologic drug substance manufacturing sites. We will present some of the outputs which aim to enhance clarity for the low-bioburden drug substance manufacturing industry and provide a risk-based roadmap for ensuring consistency in environmental monitoring and contamination control practices across the industry.
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.
1415 – 1445
Good Engineering Practice - Investment Management
Description Coming Soon!
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.
1445 – 1530
Networking
1530 – 1600
Sustainability
Academic Test Rate, Ispe
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.
1530 – 1600
GAMP
Costanza Stocchi, MAASI Enterprises
Irene Barlacchi, MAASI Enterprises
Eugenio Benedetti, Siena Imaging
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
Biotech: Large Molecules - Cell & Gene - ATMPs
Patrick Fowler, Pfizer
Tim Mahoney, J&J
Closed systems are increasingly used in low-bioburden biologic drug substance manufacturing. We will outline a comprehensive risk assessment framework, known as Closure Analysis Risk Assessment (CLARA), which is specifically tailored for the biopharmaceutical industry to demonstrate that viable and non-viable agents found in the environment that could potentially contaminate the biopharmaceutical product, have been removed from the closed process system prior to introduction of process or product materials.
1530 – 1600
Pharma 4.0/Digital Transformation
Alexandros Trompetas, Famar
FAMAR, a leading European contract manufacturing and development organization (CDMO), embarked on a significant digital transformation journey to implement electronic quality management systems managing crucial operational processes such as documents, training, auditing & suppliers, across its geographically dispersed multiple-site organization. As part of a broader initiative to streamline processes and enhance efficiency, a cloud-based SaaS solution was selected, and a phased roll-out strategy was adopted. While the transition to a paperless system promised significant improvements in compliance, document management training efficiency, and auditing pro-activeness, it also presented considerable challenges, particularly around user adoption, digital literacy, CDMO complexity given different customer demands and infrastructure limitations. This presentation will detail how FAMAR tackled these challenges, from change resistance to overcoming technological barriers, the strategies implemented for employee engagement, and awareness campaigns enrolled.
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
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
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.
1600 – 1630
Biotech: Large Molecules - Cell & Gene - ATMPs
Bianca Bohrer, PSM GmbH Topmedicare
Theresa Ladwig, Skan AG
Pharmaceutical isolators with integrated hydrogen peroxide decontamination systems are a cornerstone of state-of-the-art contamination control strategy (CCS) for aseptic processing. New EU GMP Annex 1 offers increased opportunity to introduce emerging technologies such as the enzyme indicators (EIs) and computer fluid dynamics (CFD) simulations to support the understanding and thus the reliability and robustness of the developed decontamination cycles. The risk-based CCS provides the basis for planning the validation of the decontamination cycle. Critical positions for the indicators (EIs) are derived from both the CFD study and the QRM of the CCS. Additional indicators are designed as part of this study. Objective: can the CFD reduce the number of indicators from the CCS under certain circumstances for ecological reasons, with identical process reliability? This presentation showcases how to facilitate cycle development on a fully gloveless aseptic isolator, by determining relevant positions through combining insights from EI and CFD studies as well as considerations of CCS.
1600 – 1630
Pharma 4.0/Digital Transformation
Christian Sonntag, PhD, SIGMA Process & Automation GmbH
Michael Petzi, CSL Behring
Lukas Viebahn, ZETA GmbH
In the face of energy shortages, rising prices, shorter time-to-market, and increasing competitive pressure, speed, flexibility, and maximum efficiency are more important than ever in the process industry. These goals can only be achieved through fully digital data management and seamless integration of digital tools over the complete lifecycle of a production plant. This presentation provides insights into how CSL Behring's new $470 million plasma fractionation plant in Marburg, Germany, was engineered and is operated using an integrated digital approach that employs highly accurate Digital Twins at each stage. The benefits are manifold: In the early phases, process alternatives were quantitatively compared, capacities estimated, or equipment sizes determined; in later phases, detailed workflows were developed, subsystems for cleaning, utilities, buffers, or resources were designed, process robustness under uncertainties ensured, optimal operating modes identified, automation and production planning developed, and commissioning supported. After commissioning, the Digital Twin was re-used in the new solution INOSIM Foresight for operations support. With accurate dynamic predictions, the solution supports the operating staff in all aspects of operation - whether through real-time planning of production, personnel, and resources, predicting and "combating" disruptions, optimal maintenance planning, efficient onboarding of new employees, and many other use cases.
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
Biotech: Large Molecules - Cell & Gene - ATMPs
Marina Ferrari, Chiesi Farmaceutici
Angelo Bernardis, MD, Wood Plc
Establishing Biopharma Drug-Substance Manufacturing Capability, from Tech-Transfer to a Modern Operational and Compliant Plant
Chiesi Farmaceutici, a well-established international Company operating in the research and manufacturing of respiratory health, rare diseases, and specialty care pharmaceuticals, has recently completed its state-of-the-art biotech center of excellence in Parma, Italy, dedicated to the development and production of Mab’s, enzymes and therapeutic proteins – a significant enhancement and innovation to bring new treatments to the market. The presentation will introduce the passionating journey for the scaleup of a promising product, the challenges of the tech-transfer from a Third-party contractor, the design of the facility with the support of Wood as A&E for the realization/startup, how Chiesi has grown/trained the staff to operate the plant – ultimately showing how the plant is ready for efficient/flexible development/manufacturing of multiple products at different scales under full GMP compliance. Will be also described the unique design features introduced for the proficient/flexible operability, the challenges addressed during engineering and construction with regards to the implementation into a constrained site, and the advanced solution adopted for a more resilient and sustainable facility.
Chiesi Farmaceutici, a well-established international Company operating in the research and manufacturing of respiratory health, rare diseases, and specialty care pharmaceuticals, has recently completed its state-of-the-art biotech center of excellence in Parma, Italy, dedicated to the development and production of Mab’s, enzymes and therapeutic proteins – a significant enhancement and innovation to bring new treatments to the market. The presentation will introduce the passionating journey for the scaleup of a promising product, the challenges of the tech-transfer from a Third-party contractor, the design of the facility with the support of Wood as A&E for the realization/startup, how Chiesi has grown/trained the staff to operate the plant – ultimately showing how the plant is ready for efficient/flexible development/manufacturing of multiple products at different scales under full GMP compliance. Will be also described the unique design features introduced for the proficient/flexible operability, the challenges addressed during engineering and construction with regards to the implementation into a constrained site, and the advanced solution adopted for a more resilient and sustainable facility.
1630 – 1700
GAMP
Martin Heitmann, D-fine GmbH
Mohammed 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
Sustainability
Tim Mahoney, 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.
1630 – 1700
Nico Erdmann, Deloitte GmbH WPG
Description Coming Soon
1900 – 2300
Networking
Included in your In-Person All Access Pass! Don't miss out on the chance to connect, indulge, and unwind at the ISPE Europe Annual Conference! Dance to the beats of our DJ or mingle and network. Join us for an unforgettable evening of networking, delicious food, and delightful entertainment!
0730 – 1700
0730 – 0900
Networking
0830 – 0845
0845 – 0915
General Session
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, Cognizant Technology Solutions
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.
1000 – 1400
1015 – 1100
Networking
1100 – 1130
Good Engineering Practice - Investment Management
Jürgen Wiedemann, Bayer
Gunnar Schuchhard, Condors
In today’s world, a fundamental shift in how projects are executed is necessary. Only through flexible and forward-thinking project concepts, combined with true collaboration, we can successfully initiate and complete projects in the future. This approach will be essential for adapting to the rapidly changing landscape and ensuring long-term success in project execution.
A prime example of this shift can be seen in the Bayer Solida 1 project. This state-of-the-art facility is designed to support Pharmaceuticals' strategy through the application of new technologies, a modular and highly flexible structure, a significant shift towards digitalization, and executed with an innovative and highly collaborative execution model. Using this successfully completed project as an example, we will demonstrate how a well-thought-out combination of innovative and flexible technologies, along with agile and collaborative project execution based on Integrated Project Delivery (IPD), enables successful project outcomes even in times of great uncertainty and external influences.
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.
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 – 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
GAMP
Brendan Walshe, Integrity Solutions
Mary White, Amneal Ireland Ltd
Presentation of Data Integrity / Data Mapping Risk assessment completed for Process Equipment. The risk assessment was completed using the APIC (Active Pharmaceutical Ingredients Committee) Practical risk-based guide for managing data integrity Version 1, March 2019. The presentation shall outline the steps taken with actual examples and the results for each step. The high level steps performed for each set of process equipment is as follows: 1. Process Mapping - Process Flow Mapping 2. Data Process Mapping - Identify data flows (In/Out) and GxP data elements (paper and electronic). 3. Data and System Categorization 4. System Assessment - Assess the gaps within the system using a Data Integrity (DI) check list. 5. Analyse the DI risk - Conduct a risk assessment(FMEA) on the gaps identified and impact on GxP data that can be modified/deleted or re-reprocesses after creation. 6. Risk Management Plan – actions and priorities to address risks identified.
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
This session provides practical guidance on ensuring compliance for digital systems at clinical sites, focusing on strategies aligned with EMA expectations and insights from the updated ISPE GAMP guide on eClinical systems. Attendees will learn essential aspects of regulatory requirements, effective implementation methods, and ongoing verification practices to maintain continuous compliance. The session highlights the benefits of digitalization, such as improved efficiency and data quality, while addressing common pitfalls and validation mistakes to avoid. It is designed to help decision-makers ensure compliance while enhancing the overall performance of clinical activities.
1130 – 1200
Good Engineering Practice - Investment Management
Tabea Martins, CRB
Abbas Sayyed, EURO API
This presentation will explore cutting-edge trends in facility design, execution, and sustainability for peptide and oligonucleotide manufacturing, with a focus on both greenfield developments and retrofitting existing facilities. Attendees will learn about innovative design strategies for new state-of-the-art oligonucleotide plants that integrate advanced technologies, enhance operational efficiency, and meet stringent GMP standards. For existing facilities, we will address examples of retrofitting solutions to optimize space, improve energy use, and incorporate the latest automation and continuous manufacturing processes. Sustainability will be a key theme, including methods for recycling manufacturing waste and reducing environmental impact. Through real-world case studies, this presentation will provide actionable insights into how pharmaceutical companies can design new greenfield sites for long-term scalability and flexibility while retrofitting existing facilities to meet modern demands without compromising sustainability or compliance.
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.
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
Trevor Seelert, Evolve Biologics
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.
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
Good Engineering Practice - Investment Management
Nadia Baldoin, FAMAR
Smart Investments, Strong Foundations: Enhancing CAPEX Efficiency with Engineering Excellence
In today's fast-paced, resource-constrained industrial environment, the challenge of balancing innovation, operational excellence, and financial prudence is more critical than ever. The efficient management of Capital Expenditure (CAPEX) is essential to the long-term sustainability and growth of pharmaceutical manufacturing and other highly regulated industries.
This presentation will explore the critical role that Good Engineering Practices (GEP) play in ensuring that investments in physical assets - such as manufacturing equipment and facilities - are optimized through robust governance structures, clear processes, and alignment with strategic goals. The process of CAPEX management, from initial project identification to final approval and post-implementation review, will be dissected, with particular focus on:
- Governance and Stakeholder Management: Ensuring that the end-to-end CAPEX process meets the needs of key stakeholders such as project sponsors, financial controllers, and resource managers.
- Project Prioritization and Approval: Outlining the criteria for project selection, approval, and the role of Investment Committees.
- Risk Mitigation and Supporting Rational: to ensure effective prioritization, approval and implementation, optimization of return on investment
- Efficient Reporting: Utilizing digital platforms for efficient CAPEX tracking, forecasting, and reporting; maintaining regular financial updates enabling accurate forecasting, tracking, and cash flow control.
In today's fast-paced, resource-constrained industrial environment, the challenge of balancing innovation, operational excellence, and financial prudence is more critical than ever. The efficient management of Capital Expenditure (CAPEX) is essential to the long-term sustainability and growth of pharmaceutical manufacturing and other highly regulated industries.
This presentation will explore the critical role that Good Engineering Practices (GEP) play in ensuring that investments in physical assets - such as manufacturing equipment and facilities - are optimized through robust governance structures, clear processes, and alignment with strategic goals. The process of CAPEX management, from initial project identification to final approval and post-implementation review, will be dissected, with particular focus on:
- Governance and Stakeholder Management: Ensuring that the end-to-end CAPEX process meets the needs of key stakeholders such as project sponsors, financial controllers, and resource managers.
- Project Prioritization and Approval: Outlining the criteria for project selection, approval, and the role of Investment Committees.
- Risk Mitigation and Supporting Rational: to ensure effective prioritization, approval and implementation, optimization of return on investment
- Efficient Reporting: Utilizing digital platforms for efficient CAPEX tracking, forecasting, and reporting; maintaining regular financial updates enabling accurate forecasting, tracking, and cash flow control.
1200 – 1230
Join us for an informative session where you'll dive into groundbreaking case studies focused on sustainability. Discover how three innovative companies are leading the charge with these stimulating topics:
1. Alternative Refrigerants in Freeze-Drying: Examines using natural refrigerants in pharmaceutical freeze-drying, highlighting design, risks, and benefits.
2. Decarbonising Pharma with Heat Pumps: Showcase integrating heat pumps to reduce carbon emissions in pharmaceutical sites, focusing on design and efficiency.
3. Digitalisation & Sustainability: Path to Net-Zero: Explores how digital technologies enhance sustainability in the Life Sciences industry, optimising energy use and reducing waste. These topics showcase how innovative approaches and technologies are being leveraged to meet sustainability goals, reflecting the latest trends and priorities in the field.
1. Alternative Refrigerants in Freeze-Drying: Examines using natural refrigerants in pharmaceutical freeze-drying, highlighting design, risks, and benefits.
2. Decarbonising Pharma with Heat Pumps: Showcase integrating heat pumps to reduce carbon emissions in pharmaceutical sites, focusing on design and efficiency.
3. Digitalisation & Sustainability: Path to Net-Zero: Explores how digital technologies enhance sustainability in the Life Sciences industry, optimising energy use and reducing waste. These topics showcase how innovative approaches and technologies are being leveraged to meet sustainability goals, reflecting the latest trends and priorities in the field.
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
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
GAMP
Oliver Herrmann, Q-FINITY Quality Management
Are the Current EU GCP CSV/DI Requirements a Blueprint for Other GxPs?
This presentation will show you why it's so important to work with critical thinkers who have the subject matter expertise and experience in the regulated field. The recently published EMA guideline on computerized systems and electronic data in clinical trials defines a detailed perspective of regulatory requirements and expectations for the clinical area. As regulated companies define their own quality management system to meet CSV and Di requirements, the current guideline could lead to a direction that reduces the possibility of interpretation and flexibility. Another indicator of the current thinking of the EU regulators could be the concept paper for the update of the EU GMP Annex 11, which implies a significant change. This presentation will provide an overview of current GCP expectations and how to address the upcoming challenges in the digital transformation of clinical processes and compare these requirements with current GxPs. Finally, the presentation will provide an outlook on what the future may hold for the regulation of computerized systems and data integrity.
This presentation will show you why it's so important to work with critical thinkers who have the subject matter expertise and experience in the regulated field. The recently published EMA guideline on computerized systems and electronic data in clinical trials defines a detailed perspective of regulatory requirements and expectations for the clinical area. As regulated companies define their own quality management system to meet CSV and Di requirements, the current guideline could lead to a direction that reduces the possibility of interpretation and flexibility. Another indicator of the current thinking of the EU regulators could be the concept paper for the update of the EU GMP Annex 11, which implies a significant change. This presentation will provide an overview of current GCP expectations and how to address the upcoming challenges in the digital transformation of clinical processes and compare these requirements with current GxPs. Finally, the presentation will provide an outlook on what the future may hold for the regulation of computerized systems and data integrity.
1230 – 1400
Networking
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
0900 – 1300
Facility Tour
Autolus is founded on advanced cell programming technology pioneered by Dr Martin Pule and was spun-out from University College London in 2014. Since its inception, the company has undergone rapid growth, systematically adding the capabilities and capital required to manufacture, develop and commercialise its programmed T cell product candidates.
Separate registration required.
Note: Buses will depart the hotel at 9:00 AM and return around 3:00 PM, allowing for up to 90 minutes of travel time each way.
Separate registration required.
Note: Buses will depart the hotel at 9:00 AM and return around 3:00 PM, allowing for up to 90 minutes of travel time each way.
0930 – 1330
Facility Tour
Join us for an exclusive tour of the Francis Crick Institute, Europe’s largest biomedical research institute. Established in 2017, the Crick brings together the MRC’s National Institute for Medical Research (NIMR) and CRUK’s London Research Institute (LRI), fostering cutting-edge scientific collaboration. Named after renowned UK scientist Francis Crick—whose work on the genetic code revolutionized our understanding of life—the institute is dedicated to exploring the fundamental mechanisms of human biology at a cellular level.
While astronomers explore the vastness of outer space, researchers at the Crick investigate the microscopic inner workings of the human body. Through groundbreaking laboratory research, the institute aims to advance the diagnosis, prevention, and treatment of diseases, shaping the future of healthcare.
This tour offers a behind-the-scenes look at world-class research facilities and the pioneering work being done to push the boundaries of biomedical science.
Separate registration required.
While astronomers explore the vastness of outer space, researchers at the Crick investigate the microscopic inner workings of the human body. Through groundbreaking laboratory research, the institute aims to advance the diagnosis, prevention, and treatment of diseases, shaping the future of healthcare.
This tour offers a behind-the-scenes look at world-class research facilities and the pioneering work being done to push the boundaries of biomedical science.
Separate registration required.
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.