Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
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Sat, 10 May
Mon, 12 May
Tue, 13 May
Wed, 14 May
0800 – 1700
Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution.
0830 – 0850
General Session
0850 – 0920
General Session
0920 – 0950
General Session
0950 – 1000
General Session
1000 – 1045
Networking
1045 – 1115
General Session
1115 – 1155
General Session
1155 – 1200
General Session
1200 – 1330
General Session
1330 – 1530
1330 – 1530
1330 – 1530
Workshops
Quality and Regulatory: What is new with GxP regulations? What does the future hold?
1330 – 1530
1330 – 1530
General Session
1530 – 1615
Networking
1615 – 1715
General Session
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, Poland, 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, Poland, 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, Poland, the Czech Republic, and Spain, providing an opportunity to address questions from the audience.
1715 – 1900
Networking
0830 – 0845
General Session
0845 – 0945
General Session
0945 – 1000
General Session
1000 – 1045
General Session
1045 – 1115
Pharma 4.0/Digital Transformation
Luis Miranda, CSL Behring AG
In this session, I will discuss approaches to create and execute a digital transformation roadmap. Using CSL's experiences as a case study, this session will highlight strategies to align enterprise goals with technological trends and overcome resistance to change. We will delve into the importance of strategic alignment and phased implementation, providing you with the tools to develop a comprehensive digital transformation strategy. Explore ways to foster a culture of innovation and proactively address organizational inertia, ensuring your digital initiatives are successful and sustainable. This is aimed at providing valuable insights and practical knowledge that will help others navigate the complexities of digital transformation and drive continuous improvements.
1045 – 1115
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
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.
1045 – 1145
Good Engineering Practice - Investment Management
Maurizio Mangiarotti, University of Siena
Leonardo Zanus, MAASI Enterprises
1045 – 1115
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.
1115 – 1145
Pharma 4.0/Digital Transformation
Daniel Borchert, Koerber
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
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.
1115 – 1145
GAMP
Thanabalan Subramanian, Integrity
Christopher Reid, Integrity Project Solutions Limited
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.
1115 – 1145
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.
1145 – 1215
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 – 1215
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.
1145 – 1215
Biotech: Large Molecules - Cell & Gene - ATMPs
Neil Gamble, Arcadis
Trevor Seelert, Evolve Bio
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 – 1215
Good Engineering Practice - Investment Management
1145 – 1215
As outlined in the BioPhorum Environmental Sustainability Roadmap in … developing and providing therapeutic medicine to treat our global population, the healthcare sector itself can impact the health of the planet [but] the ability of the biopharmaceutical industry to operate relies on a healthy planet. This presentation will focus on the concept of water stewardship as opposed to water management, looking beyond site boundaries to understand water as a key sustainability challenge and risk area for the biopharma industry. To maintain business continuity and avoid impacting access to medicines, the sector needs to rethink its approach to water. This challenge is highlighted in BioPhorum’s paper "A Case for Shifting to Water Stewardship in the Biopharma Industry."
Biologics manufacturing processes are water intense and direct costs for water are relatively inexpensive. There is no alternative raw material for the many uses of water in manufacturing, either for traditional large-batch facilities or the continuous, ‘next-generation’ processing that many companies have in development. We will explore water stewardship in the context of biopharma, with a specific focus on
- The business case for looking beyond water efficiency within site boundaries to manage exposure to water risks, such as water scarcity, flooding, or poor quality.
- Strategies to drive action at the company level.
- Case studies of the positive impact of water stewardship.
Biologics manufacturing processes are water intense and direct costs for water are relatively inexpensive. There is no alternative raw material for the many uses of water in manufacturing, either for traditional large-batch facilities or the continuous, ‘next-generation’ processing that many companies have in development. We will explore water stewardship in the context of biopharma, with a specific focus on
- The business case for looking beyond water efficiency within site boundaries to manage exposure to water risks, such as water scarcity, flooding, or poor quality.
- Strategies to drive action at the company level.
- Case studies of the positive impact of water stewardship.
1215 – 1345
Networking
1345 – 1415
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).
1345 – 1415
Pharma 4.0/Digital Transformation
Anne Bard, GSK UK - GSK House
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.
1345 – 1415
Good Engineering Practice - Investment Management
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
GAMP
Thomas Makait, MTP4Pharma® - Intrinsic Plug & Produce 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.
1345 – 1415
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.
1415 – 1445
Pharma 4.0/Digital Transformation
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.
1415 – 1445
Good Engineering Practice - Investment Management
Theresa Ahern, Eli Lilly
Paul Osborne, BioPhorum
Michael Vrijis, Incyte
1415 – 1445
Sustainability
Integration of Sustainability Objectives on Pharma Project - From Feasibility Stage Until Construction
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
Sustainability requirements must be followed as Quality requirements all through a project. A parallel will be done between Sustainability and Quality requirement management. This presentation will highlight some examples of integration of Sustainability objectives through technical studies: building thermal studies, multi-criteria analysis with sustainable criteria for HVAC Hot Water production solutions, energy saving by design using Water For Injection membrane production, workfront management, and digitalization during construction (reduce rework, reduce waste). This presentation aims to open discussion regarding problems encountered during recent projects on Sustainability topics.
1415 – 1445
Biotech: Large Molecules - Cell & Gene - ATMPs
Patients are waiting for lifesaving and improving medications, and often Cell and Gene Therapies are the only treatment option from the start, or they have exhausted all other options in the small molecule and biologics spaces. It is critical to be able to develop, manufacture, and distribute Cell and Gene Therapies in a compliant and efficient manner throughout the world. But at the same time, the regulations are not aligned and are continuing to evolve. Regulatory requirements for ATMPs are not aligned between the US FDA and EMA and it is critical to understand the differences, plan for them, and address them early in one's clinical program. A challenge that continues to reoccur is when a clinical strategy shifts from a US-only clinical strategy to include the EU as well and the process and facility are not compliant with EU GMPs and the new EU Annex 1 revision.
1415 – 1445
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.
1445 – 1515
Pharma 4.0/Digital Transformation
Thomas Hiltbrand, Crypto Pharma
Thomas Hiltbrand, Crypto Pharma
Yacine Haddadi, BD Medical - Phamaceutical Systems
JRK IS Still Testing, Exyte
The fill/finish stage of pharmaceutical manufacturing is increasingly becoming a critical bottleneck for many companies. According to a McKinsey report, "The world will need more sterile products than manufacturers have or can build capacity for." At the same time, regulatory authorities are raising the bar for traceability during production to drive a significant improvement in quality. Consequently, finding solutions to enhance the efficiency of existing processes and equipment, while simultaneously meeting these stringent regulatory demands, is more crucial than ever. This presentation introduces an innovative solution to tackle the dual challenges of increasing fill/finish capacity and meeting enhanced quality requirements through RFID-based unit-level traceability.
Unit-level tracking is enabled by integrating RFID tags directly into primary packaging containers. This advanced traceability method provides a technical safeguard against mix-ups, boosts production efficiency by allowing precise segregation of batches when quality issues arise, automates reconciliation across multiple production stages, and significantly reduces or eliminates labor-intensive steps during visual inspection assessments and related operator qualification.
Unit-level tracking is enabled by integrating RFID tags directly into primary packaging containers. This advanced traceability method provides a technical safeguard against mix-ups, boosts production efficiency by allowing precise segregation of batches when quality issues arise, automates reconciliation across multiple production stages, and significantly reduces or eliminates labor-intensive steps during visual inspection assessments and related operator qualification.
1445 – 1515
Biotech: Large Molecules - Cell & Gene - ATMPs
Paul Osborne, BioPhorum
Stephanie Whitmore, Eli Lilly & Company
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.
1445 – 1515
Sustainability
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.
1445 – 1515
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.
1515 – 1600
Networking
1600 – 1630
Good Engineering Practice - Investment Management
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.
1600 – 1630
Biotech: Large Molecules - Cell & Gene - ATMPs
Paul Osborne, BioPhorum
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.
1600 – 1730
Sustainability
The manufacture of sterile products is carried out in a cleanroom, where it must maintain a cleanliness grade compliant with Annex 1. HVAC plays a key role, but on the other end, it means a significant energy cost. The aim of this presentation is to speak about the triggers that influence the HVAC design and the strategies that have been adopted in recent projects to reduce the energy cost of the HVAC, such as: definition of the Air Change based on the contamination source; design for Air Reduction Mode; progress on Adaptive Flow Control, considering the airborne control measurement system; and selection and design of an HVAC System with a low SFP (Specific Fan Power).MEAN, and GREEN - along with energy modeling, early carbon-impact identification, and collaboration as critical to achieving Net Zero goals, with carbon offsetting as a last resort.
1600 – 1630
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.
1600 – 1630
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.
1630 – 1700
GAMP
Chris Kenny, Fresenius Kabi
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 Fresenius Kabi 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 Fresenius Kabi 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.
1630 – 1700
Good Engineering Practice - Investment Management
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.
1630 – 1700
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.
1630 – 1700
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
Biotech: Large Molecules - Cell & Gene - ATMPs
Bianca Bohrer, PSM GmbH Topmedicare
Theresa Ladwig, Skan AG
Aseptically processed biopharmaceuticals and emerging technologies create increasing demands on H2O2 decontamination cycle times, effectiveness, and permitted H2O2 residual limits. This presentation guides through the latest innovations in H2O2 decontamination solution with its advantages and meeting the latest cGMP and regulatory requirements i.e., Annex 1. With the development of H2O2 decontamination cycles on fully gloveless isolators new challenges will be discovered, and according processes need to be established. Furthermore, a process for cleaning and quantification of cleaning for a fully gloveless automated filling line needs to be established and validated. Therefore, the bullet points which need to be covered for both validation steps will be:
- Goal
- Approach
- General aspects
- Tools
- Challenges
This presentation will show the execution and lessons learned from the validation of the filling line after we have implemented the line.
- Goal
- Approach
- General aspects
- Tools
- Challenges
This presentation will show the execution and lessons learned from the validation of the filling line after we have implemented the line.
1700 – 1730
GAMP
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.
1700 – 1730
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.
1700 – 1730
Good Engineering Practice - Investment Management
0900 – 0915
General Session
0915 – 1015
General Session
1015 – 1100
Networking
1100 – 1130
Biotech: Large Molecules - Cell & Gene - ATMPs
Angelo Bernardis, 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.
1100 – 1130
Pharma 4.0/Digital Transformation
Andrea Kurz, F. Hoffmann-La Roche Ltd in Basel
This presentation gives an overview of the ICMRA's Collaborative Hybrid Inspection Pilot (CHIP) from the Industry's Perspective. The CHIP provides an opportunity to reach an agreement from multiple authorities on the compliance of a site with a single inspection activity. This presentation illustrates a company's journey in preparing, organizing, and hosting a CHIP inspection performed jointly by multiple authorities, being on-site and remotely, under the lead of an on-site inspectorate. The presentation talks about the challenges, opportunities, and benefits of the CHIP. The presentation engages in the conversation on how ultimately such a pilot can further support reliance and convergence efforts amongst regulators.
1100 – 1115
Sustainability
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
Good Engineering Practice - Investment Management
Jürgen Wiedemann, Bayer
1115 – 1130
Sustainability
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
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 – 1200
Biotech: Large Molecules - Cell & Gene - ATMPs
Marco Flori, Staubli Robotic UK
Dan Strange, Cellular Origins
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.
1130 – 1200
GAMP
Anna Dachs, AMBIT-BST
This talk covers the essential aspects of establishing and verifying compliance for digital systems at clinical sites, focusing on practical strategies and common pitfalls to avoid, considering the EMA expectations and the ISPE GAMP updated guide on eClinical systems.
1130 – 1145
Sustainability
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
Philip Jarvis, GWWO Grifols
David O'Connor, MSD
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.
1145 – 1200
Sustainability
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
Sustainability
1200 – 1230
Biotech: Large Molecules - Cell & Gene - ATMPs
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
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
1415 – 1445
General Session
1445 – 1615
General Session
Regulatory panel discussion.
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.