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Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Good Engineering Practice - Investment Management
Tue, 13 May
Wed, 14 May
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.
1045 – 1115
Good Engineering Practice - Investment Management
Ryan O'Sullivan, Eli Lilly
Daniel Breen, Eli Lilly
This presentation is focused on the development of a synthetic peptide manufacturing platform and facility by Eli Lilly Kinsale, Ireland.
The presentation will include an overview of the Kinsale site with a detailed look at the FOYA winning IE2b facility.
The speakers will present on the steps involved in crude peptide synthesis and the use of continuous processing for liquid phase peptide synthesis (LPPS). This will include a breakdown of the individual unit operations and a walkthrough of the equipment, including a description of the nanofiltration technology in use at Kinsale.
This presentation will also give an insight into the importance of digital technology in driving quality and compliance through an industry-first material tracking system.
1115 – 1145
Good Engineering Practice - Investment Management
Giulio Ripaccioli, GSK Vaccines
Leonardo Zanus, MAASI Enterprises
The pharmaceutical sector is characterized by high complexity and continuous challenges, requiring meticulous risk management to ensure project success. This rapid-fire session aims to emphasize the importance of risk management as an "integral element of good project management practice" [GAMP 5 11.5.3.2] in pharmaceutical projects through real-world experiences and lessons learned. During the session, multiple viewpoints will be presented by two experienced speakers, and several case studies will be presented, highlighting both the effective application of risk management and the consequences of its absence. We will walk through practical examples of how early risk identification and mitigation contribute to achieving project goals or, conversely, how the lack of a proper risk management approach leads to delays, unexpected costs, and failures.
1315 – 1345
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.
1415 – 1445
Good Engineering Practice - Investment Management
Gwendolyn Foster, Lonza AG
This case study explores how updated Annex 1 guidance was pragmatically applied to a large-scale biopharmaceutical facility already under construction at the time of the 2022 revision. While full implementation was not feasible due to project timing, a structured process closure analysis was used to justify targeted reductions in cleanroom classifications—ensuring alignment with regulatory expectations through scientifically supported decisions.
The presentation details how process understanding, risk-based thinking, and collaboration across disciplines enabled these changes. It also outlines the potential savings identified across construction, operations, labor, and environmental control, and how these insights will inform future facility designs where Annex 1 principles can be embedded from the outset. This is not presented as a definitive model, but rather as one practical example of adapting to evolving regulatory requirements through thoughtful, evidence-based implementation.
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.
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.
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.
1100 – 1130
Good Engineering Practice - Investment Management
Jürgen Wiedemann, Bayer
Gunnar Schuchhardt, Condots
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.
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.
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.
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.