Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Sessions
Equipping People Who Accelerate Pharma 4.0 Transformation
Dec 10, 2024 | 1110 - 1130
Presenter: Malcolm Jeffers, IAAE
During this presentation the roles of manufacturing leader and data steward will be covered, with emphasis given to examples of key knowledge, sources of information, and expected behaviours, that are considered important at several career stages for these roles. The entire set of role profiles developed by these organisations will be made available at the end of the presentation, with likely benefits for engineering, manufacturing operations, HR, L&D, and other leaders seeking to better equip and develop their teams to accelerate Pharma 4.0 transformations.
Understanding Digitalization and Its Potential in Pharma 4.0
Dec 10, 2024 | 1130 - 1150
Presenter: Chris Grail, Bayer
Understanding Digitalization and its Potential as a Value Driver in Pharma 4.0. In this keynote presentation, we will explore how we can drive the potential of digitalization in Pharma 4.0. A key aspect of a successful digitalization strategy is the explanation and understanding of the tools and technologies, to empower teams and individuals to drive the potential to tangible value in processes and operations. By exploring recent success stories within Bayer, we will demonstrate how digitalization can be used as a catalyst for streamlined processes, improved efficiencies and better decision making in the pharmaceutical industry.
All session times are listed in Central European Time (CET). Find your personal viewing time on the World Clock.
Filters
Tue, 10 Dec
Wed, 11 Dec
Thu, 12 Dec
0800 – 1930
Registration open: Tuesday, 10 December 0800-1930 CET.
Registration will also be open on Monday, 9 December from 1300-1700 CET.
Registration will also be open on Monday, 9 December from 1300-1700 CET.
0900 – 0905
General Session
Michael Rutherford, ISPE
0905 – 0915
0915 – 0935
General Session
Uwe Bucheler, PhD, Former Head of Biopharma Business Unit, Boehringer Ingelheim
The first Biopharmaceuticals were launched 30 years ago. Since then, Biopharmaceuticals rapidly emerged to major new therapeutic options for patients. The talk will discuss, what industry learned over the years regarding (Glyco-)Protein manufacturing and what changes are now triggered based on very diverse molecular formats of New Biologics Modalities (RNA; Virus, Cell therapies, Exosomes…). The paradigm shift in facility set up, automation and scale up versus scale out will be addressed. In the outlook, key success factors how to reliably serve patients with innovative therapies will be shared.
0935 – 0955
This keynote presentation will focus on: Exploring the strategies and considerations involved in building fill & finish facilities across a global manufacturing network. Discussing the importance of harmonization, global standards, digitalization, and connectivity in pharmaceutical manufacturing and how we ensure consistency and quality across our facilities. Understanding the opportunities, challenges and approaches in maintaining regulatory compliance when expanding fill & finish capabilities. Exploring the role of innovation and technology in enhancing efficiency and quality.
0955 – 1015
General Session
Christina Meissner, AGES - Austrian Agency for Health and Food Safety
Ronald Bauer, PhD, Austrian Agency for Health and Food Safety (AGES)
Data management requirements for sterile manufacturing processes
The presentation will highlight the requirements for data management in the light of sterile manufacturing. The inspectors will share experiences with the implementation of Annex 1 in reference to Chapter 4 and Annex 11 based on new developments in the field. They will highlight expectations on successful contamination control strategy implementation and on data driven manufacturing processes and quality oversight.
The presentation will highlight the requirements for data management in the light of sterile manufacturing. The inspectors will share experiences with the implementation of Annex 1 in reference to Chapter 4 and Annex 11 based on new developments in the field. They will highlight expectations on successful contamination control strategy implementation and on data driven manufacturing processes and quality oversight.
1000 – 1900
Networking
1015 – 1025
General Session
Line Lundsberg-Nielsen, NNE
Richard Denk, SKAN AG
1025 – 1110
Networking
1110 – 1130
The Life Sciences Advisory Board of the International Academy of Automation Engineering, including several representatives from Amgen, ThermoFisher, and Vertex Pharmaceuticals, have developed a set of profiles for key roles who lead the Life Sciences industry forward through innovative manufacturing, to ensure better medicines, devices, and diagnostics for patients.
During this presentation the roles of manufacturing leader and data steward will be covered, with emphasis given to examples of key knowledge, sources of information, and expected behaviours, that are considered important at several career stages for these roles.
The entire set of role profiles developed by these organisations will be made available at the end of the presentation, with likely benefits for engineering, manufacturing operations, HR, L&D, and other leaders seeking to better equip and develop their teams to accelerate Pharma 4.0 transformations.
1130 – 1150
General Session
Marco Cesana, Bayer Healthcare Manufacturing SRL
Understanding Digitalization and its Potential as a Value Driver in Pharma 4.0. In this keynote presentation, we will explore how we can drive the potential of digitalization in Pharma 4.0. A key aspect of a successful digitalization strategy is the explanation and understanding of the tools and technologies, to empower teams and individuals to drive the potential to tangible value in processes and operations. By exploring recent success stories within Bayer, we will demonstrate how digitalization can be used as a catalyst for streamlined processes, improved efficiencies and better decision making in the pharmaceutical industry.
1200 – 1330
Networking
1330 – 1400
Pharma 4.0 Interconnected Facility Design and Construction
Alan Bateman, Johnson & Johnson Innovative Medicines
Planning for the Future with Pharma 4.0 in a Greenfield Project.
In my presentation, I will emphasize the importance of designing a smart manufacturing facility with interconnectivity in mind, keeping an eye on the future. I will share practical tools, processes, and approaches to ensure that our facilities are equipped with the latest capabilities and, be as foreseeably well-prepared for the evolving needs of the industry into the next decade. Attendees can expect to gain valuable insights on how to navigate the complexities of designing for the future. I will highlight some key factors such as benchmarking, leveraging guidance resources, and adopting maturity models. By the end of the presentation, attendees will have a clearer understanding of how to approach smart manufacturing facility design and be equipped with useful takeaways to drive their own projects forward.
1330 – 1400
How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation
David Estapé, CRB Group GmbH
The future success of providing widespread access to personalized Advanced Therapy Medicinal Products (ATMPs) hinges on transitioning from manual operations in Grade A environments to fully automated kit systems in lower grade settings, such as Grade D. A key in this journey will be closed system technology.
Closed system technology is a door opener to system automation, and digitalization plays a pivotal role in enhancing closed processing by facilitating real-time monitoring and control. This synergy will be key in the development of new concepts or technologies.
However, questions arise regarding the acceptance and facilitation of closed processing by regulatory agencies. How do regulatory guidelines, including Part IV and Annex 2A for ATMPs, or the new Annex 1, accommodate advancements in closed technology? Could regulatory requirements serve as a barrier to future developments, or can closed processing be strategically positioned within contamination control strategies?
This presentation will explore the regulatory history of closed processing, its evolution towards a more prescriptive approach, and the benefits and challenges of its implementation for ATMPs. It will address interpreting regulatory requirements accurately and discuss how digitalization could alleviate regulatory concerns and foster the development of closed systems.
Closed system technology is a door opener to system automation, and digitalization plays a pivotal role in enhancing closed processing by facilitating real-time monitoring and control. This synergy will be key in the development of new concepts or technologies.
However, questions arise regarding the acceptance and facilitation of closed processing by regulatory agencies. How do regulatory guidelines, including Part IV and Annex 2A for ATMPs, or the new Annex 1, accommodate advancements in closed technology? Could regulatory requirements serve as a barrier to future developments, or can closed processing be strategically positioned within contamination control strategies?
This presentation will explore the regulatory history of closed processing, its evolution towards a more prescriptive approach, and the benefits and challenges of its implementation for ATMPs. It will address interpreting regulatory requirements accurately and discuss how digitalization could alleviate regulatory concerns and foster the development of closed systems.
1400 – 1430
How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation
Kees Mensch, NecstGen
Comprehensive Overview of a Fully Digital ATMP Facility Setup at NecstGen: Embracing a Cloud-First Strategy, Integral Data Management, Digital Validation, and Incremental Changes with Testing Robots. This presentation delves into Guiding Principles & Culture, Roadmap, Implementation Decisions, Lessons Learned, Pitfalls, Benefits, Technical and Cultural Impacts, Digital Validation, and Integration with Pharma 4.0 Framework. The presentation highlights how digital setups reduce operational and change costs, ultimately lowering the price per product by presenting examples of high initial setup costs and subsequent cost reductions through user interaction and system flexibility. Which risks have been anticipated and which risks have occurred to give an insight between the perception of risks and the reality in this case.
1400 – 1430
Pharma 4.0 Interconnected Facility Design and Construction
Charles Heise, PhD, FUJIFILM Diosynth Biotechnologies Ltd
The future biomanufacturing facility is envisioned as a fully autonomous, continuous operation. Despite common use in other industries, biomanufacturing is yet to adopt this. Barriers include technical, operational, cultural, and regulatory issues. A cross-industry team is working towards this goal, having identified over 100 gaps in continuous downstream bioprocessing. They’ve created a risk assessment blueprint, simplified control at the unit operation level, and are working on a roadmap for autonomous bioprocess control. By addressing key areas like risk assessment and control/connectivity, we’re progressing towards flexible, resilient, and sustainable biomanufacturing facilities with the ultimate goal of achieving lights out manufacturing.
1430 – 1500
Pharma 4.0 Interconnected Facility Design and Construction
Christina Stern, Takeda Austria GmbH
Martin Raab, Takeda Austria GmbH
Bridging Innovation and Compliance: Covering Pharma 4.0 Technologies and Annex 1.
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.
1430 – 1500
How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation
Martin Müllner, Boehringer Ingelheim
Susan Cleary, Novatek International
The presentation will cover the successes and difficulties faced during the 6-year project and the lessons learned for both the pharmaceutical manufacturer and the vendor. The discussion will cover the global roll out of the system including the order in which the sites were selected, and the approach that was followed to bring the system to each site. Attendees will learn about the implementation process, the steps followed to harmonize processes across different sites and how digitalization reduced the number of incidents and how Boehringer Ingelheim used the system to achieve their success.
The session will include details regarding the system lifecycle, updates, and go live milestones for the global system roll out at ten Boehringer Ingelheim sites, across three continents, on a single instance multi-tenant environment. Details on the hardware, and digitalized system requirements to meet with the Annex 1 regulations for contamination control including trend and audit trail review requirements as well as autosaving sampling activities and a paperless process to achieve data integrity will be presented.
The session will include details regarding the system lifecycle, updates, and go live milestones for the global system roll out at ten Boehringer Ingelheim sites, across three continents, on a single instance multi-tenant environment. Details on the hardware, and digitalized system requirements to meet with the Annex 1 regulations for contamination control including trend and audit trail review requirements as well as autosaving sampling activities and a paperless process to achieve data integrity will be presented.
1500 – 1545
Networking
1545 – 1610
How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation
Paul Fiorio, Bayer
Implementation of EU GMP Annex1 requirements for Critical Starting Materials, Gene Editing Reagents used for CGT manufacturing.
The presentation will provide background on how EMA considers Critical Starting Materials (such as Plasmids) for CGT products according to EMA document : EMA/246400/2021. How to select the GMP principles including EU GMPs for ATMPs and EU GMP Annex 1 requirements, depending on the final use of the critical starting material/ Gene Editing Reagent(s). Finally a concrete example for Implementation of Annex 1 requirements for Enzymatic DNA manufacturing Activities.
The presentation will provide background on how EMA considers Critical Starting Materials (such as Plasmids) for CGT products according to EMA document : EMA/246400/2021. How to select the GMP principles including EU GMPs for ATMPs and EU GMP Annex 1 requirements, depending on the final use of the critical starting material/ Gene Editing Reagent(s). Finally a concrete example for Implementation of Annex 1 requirements for Enzymatic DNA manufacturing Activities.
1545 – 1610
Pharma 4.0 Interconnected Facility Design and Construction
Simon Webb, Liminos
Simon Capewell, AstraZeneca
A practical approach to developing a vision, strategy, design, construction, and operationalizing a greenfield Pharma 4.0 manufacturing facility. A case study of the new AstraZeneca continuous API commercialization facility currently being built in Dublin will be showcased. This will cover technology and data, but also the importance of process redesign and the people change required.
1610 – 1635
Pharma 4.0 Interconnected Facility Design and Construction
Guido Kremer-van Der Kamp, Merck Chemicals GmbH
Since the definition of ballroom concept was first introduced in 2013 via ISPE’s Baseline Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities, the industry has looked for opportunities to further build in flexibility for bioprocessing and biomanufacturing into facility design. At the same time, as an industry we are also being challenged on our pace of adoption of industry 4.0 principles, with pharma and life sciences behind the curve compared to other major manufacturing industry segments. This presentation will address: the journey of the industry to ballroom concepts; the current (and known future) industry challenges when aiming for a fully connected digital plant; and the considerations to take when designing for an interconnected facility that retains the flexibility of open ballroom concepts, with reference to recent BioPhorum publications and initiatives (including closed systems, modular and mobile design via plug and play, and facility-and process-level digital twins) as well as other industry standards and consortia works.
1610 – 1635
How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation
Laurens Vergauwen, Merck Group
Introduction to Raman spectroscopy and its application in mRNA manufacturing
In the rapidly growing field of mRNA medicines, monitoring the efficiency and integrity of the In Vitro Transcription (IVT) is crucial. Precise monitoring of nucleoside triphosphate (NTP) bases and RNA molecules during IVT is essential for optimizing reaction conditions and ensuring high-fidelity RNA synthesis. Traditional methods for quantifying NTP bases and RNA molecules, such as UV absorbance, fluorescence or HPLC methods, provide valuable data, but often suffer from limitations including the need for extensive sample preparation which can lead to significant delays and potential degradation of samples. This presentation discusses the innovative use of Raman spectroscopy as a non-destructive analytical tool that overcomes the limitations of conventional techniques. A data driven case study will be highlighted which shows that Raman spectroscopy can be used to monitor the consumption of NTPs and formation of mRNA product during the IVT reaction.
In the rapidly growing field of mRNA medicines, monitoring the efficiency and integrity of the In Vitro Transcription (IVT) is crucial. Precise monitoring of nucleoside triphosphate (NTP) bases and RNA molecules during IVT is essential for optimizing reaction conditions and ensuring high-fidelity RNA synthesis. Traditional methods for quantifying NTP bases and RNA molecules, such as UV absorbance, fluorescence or HPLC methods, provide valuable data, but often suffer from limitations including the need for extensive sample preparation which can lead to significant delays and potential degradation of samples. This presentation discusses the innovative use of Raman spectroscopy as a non-destructive analytical tool that overcomes the limitations of conventional techniques. A data driven case study will be highlighted which shows that Raman spectroscopy can be used to monitor the consumption of NTPs and formation of mRNA product during the IVT reaction.
1635 – 1700
Pharma 4.0 Interconnected Facility Design and Construction
Dominik Rabus, PhD, RABUS.TECH
Johannes Schoen, Boehringer Ingelheim
Supply Chain Solution via Cloud-Based Analytics and NIR-Scanners.
To accelerate the local detection of falsified medicines and strengthen the integrity of
pharmaceutical supply chains, a cloud based analytical drug screening solution has
been developed. The backbone of the solution is a secure, cloud-based database
containing details of the composition of medicines. Data science and AI have been
used to build prediction models to capture the manufacturing variability of solid drugs of
a given pharmaceutical company produced in different dosages, raw materials, and
locations. In the field, a drug sample can be authenticated using a mobile analytical
drug screening device containing a spectral sensor that transmits and within seconds
receives the results utilizing the database via a smartphone app. The solution allows in
principle anybody to verify a sample’s authenticity within minutes.
Until now, suspect drugs have typically been shipped to a central QC laboratory which can take several weeks for obtaining the final result due to delays in transportation, customs, etc. The presented solution has cut the authentication time to a matter of days. This helps our pharmaceutical partners work with local health and law enforcement authorities to combat the worldwide threat to public health represented by falsified medicines.
1635 – 1700
How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation
Francesco Cicirello, BioNTech US Inc.
Sharlene Lugo, BionTech SE
Conversations on Annex 1 & ATMPs, QbD & Modular Manufacturing
Join Sharlene and Francesco as they engage in a dialogue around the applicability of Annex 1 to ATMP and discuss the following questions in a casual setting: Is the answer to when to apply Annex 1 based on science and process able to navigate through the main jurisdictions and different codes of GMP? Is Quality by Design a strategy that could help streamline the use of platform technology in early phase? Would the application of Quality Risk Management be sufficient to justify and rationalize a pre-qualification strategy for Modular Manufacturing based on cleanroom in line with Annex 1?
Join Sharlene and Francesco as they engage in a dialogue around the applicability of Annex 1 to ATMP and discuss the following questions in a casual setting: Is the answer to when to apply Annex 1 based on science and process able to navigate through the main jurisdictions and different codes of GMP? Is Quality by Design a strategy that could help streamline the use of platform technology in early phase? Would the application of Quality Risk Management be sufficient to justify and rationalize a pre-qualification strategy for Modular Manufacturing based on cleanroom in line with Annex 1?
1700 – 1900
Networking
2000 – 2200
Separate registration through the affiliate required. To learn more and register, visit this link: Reception Registration
Join the ISPE Italy Affiliate for a Networking Reception on Tuesday, 10 December 2024 from 8 PM CET.
Location:
MAIO Rooftop
Via del Tritone 61 (Rinascente, 6° & 7° floor)
00187 Rome - Italy
Transportation will be provided to/from the conference venue and offsite reception.
Join the ISPE Italy Affiliate for a Networking Reception on Tuesday, 10 December 2024 from 8 PM CET.
Location:
MAIO Rooftop
Via del Tritone 61 (Rinascente, 6° & 7° floor)
00187 Rome - Italy
Transportation will be provided to/from the conference venue and offsite reception.
0900 – 0905
0905 – 0910
General Session
Giovanni Mattoni, Zambon Group SpA
Thomas Carganico, PQE Group
0910 – 1000
General Session
Laura Kuger, Takeda
Federico Maria Angeloro, PQE Group
Elisabetta Marani
Ylva Ek, Robur Life Science Advisory AB
Pioneering Change: Innovation across Life Science Sustainability & ESG excellence, powered and led by Women in Pharma
All economic sectors, including the Life Science, are undergoing a significant transformation driven by the increasing focus on integrating environmental, social, and governance (ESG) criteria into their strategies and activities. This panel will explore the best strategies and practices by which manufacturing companies are responding to the pressures from different stakeholders (customers, regulators, suppliers, and employees), as well as regulators, implementing low environmental impact technical innovations and promoting a more sustainable workplace. Coming effective in 2025, the EU Legislation CSRD is paving the way for a huge change in business as it will require extensive and detailed disclosure about how sustainability issues are addressed by companies and related risks, opportunities and strategic action plans for the implementation of good business practices in their quality systems such as gender equity policies, sustainable procurement and supplier qualifications processes, as well as environmental impacts and decarbonization strategies.
All economic sectors, including the Life Science, are undergoing a significant transformation driven by the increasing focus on integrating environmental, social, and governance (ESG) criteria into their strategies and activities. This panel will explore the best strategies and practices by which manufacturing companies are responding to the pressures from different stakeholders (customers, regulators, suppliers, and employees), as well as regulators, implementing low environmental impact technical innovations and promoting a more sustainable workplace. Coming effective in 2025, the EU Legislation CSRD is paving the way for a huge change in business as it will require extensive and detailed disclosure about how sustainability issues are addressed by companies and related risks, opportunities and strategic action plans for the implementation of good business practices in their quality systems such as gender equity policies, sustainable procurement and supplier qualifications processes, as well as environmental impacts and decarbonization strategies.
1000 – 1045
Networking
1000 – 1345
Networking
1045 – 1115
Pharma 4.0 Case Studies and Lessons Learned
Rolf Traut, Takeda Pharmaceuticals
Sergio Torralbo Jimenez, Takeda Pharmaceutical Co Ltd
The rapid advancements in Industry 4.0 requires robust, scalable, and integrated digital data platforms to harness the full potential of manufacturing data. The corporate data platform aims to unify disparate data sources (PLCs, SCADAs, IPC equipment, etc.), enabling seamless data contextualization, processing and analysis. By leveraging cloud-based technologies, it allows the use of manufacturing data (historical and real-time) for advanced analytics, predictive maintenance and machine learning algorithms. It supports a wide array of data types, including IIoT sensor data, process time series data and alarm and events, ensuring a holistic availability of manufacturing process information. The emphasis lies on scalability and easy access to the platform for end users in the sites. Beyond the initial installation of the platform in our the sites, it is obvious that the value of the program is delivered through site use cases implementation. For this purpose, a comprehensive integration tool and several standards have been developed to support the platform use cases creation in the sites, facilitating an easy integration with legacy and new manufacturing systems and third-party applications. Security and data integrity are as well prioritized through state-of-the-art encryption and compliance with industry standards. By transforming raw manufacturing data into actionable intelligence, this digital data platform not only will allow the continuous production optimization but will also enable innovation and competitive advantage in our manufacturing landscape.
1045 – 1115
Annex 1 Implementation & Pharma 4.0
Ruben Van Der Galiën, GEHealthcare
A Contamination Control Strategy (CCS) is a document which focuses on how to prevent contaminations with microorganisms, particles and pyrogens within a sterile and/or aseptic and preferably also in non-sterile manufacturing facilities. This document determines in what extent measures and controls in place are efficient in preventing contamination. In order to efficiently evaluate and control all potential hazards associated with sources of contamination within a CCS, the Hazard Analysis Critical Control Point (HACCP) methodology could be a useful tool to monitor all Critical Control Points (CCPs) related to various sources of contamination. This article describes a way to set up the CCS within a pharmaceutical sterile and aseptic manufacturing facility (GE HealthCare Pharmaceutical Diagnostics) applying the HACCP methodology. In 2021, a global CCS procedure and a general HACCP template became effective for the GE HealthCare Pharmaceutical Diagnostics sites having sterile and/or aseptic manufacturing processes. This procedure guides the sites through the set-up of the CCS applying the HACCP methodology and helps each site to evaluate whether the CCS is still effective taking all (proactive and retrospective) data following the CCS into account. A summary of setting up a CCS using the HACCP methodology, specifically for the pharmaceutical company GE HealthCare Pharmaceutical Diagnostics Eindhoven site, is provided in this article. Using the HACCP methodology enables a company to include proactive data within the CCS, making use of all identified sources of contamination, associated hazards and/or control measures and CCPs. The constructed CCS allows the manufacturer to identify whether all included sources of contamination are under control and, if not, which mitigatory actions need to be performed. All current states are reflected by a traffic light color to reflect the level of residual risk, thereby providing a simple and clear visual representation of the current contamination control and microbial state of the manufacturing site.
1115 – 1145
Annex 1 Implementation & Pharma 4.0
Runa Ulsoe, UCB Pharma
Giuseppe Leonardi, UCB PHARMA S.P.A.
The Updated Annex 1 that went into force in August 2023 has been revised to:
• Reflect changes in regulatory and manufacturing environments and in the advanced technology in contamination control
• Incorporate principles of ICH Q9 Risk Management ICH Q10 Pharmaceutical Quality System and using this when taking advantage of the new possibilities by using innovative tools
• To correct inaccuracies and offer more detail to remove ambiguity
• Align this guideline with international requirements
• Clarify other areas of potential applicability of Annex 1 utilizing QRM principles
The new Annex 1 has been significantly expanded, however there is room for interpretation when it comes to how to be compliant with the updated version. In this presentation we will provide an 'auditors view' on how to verify/challenge if companies are compliant with the updated Annex one, illustrated by sharing experiences from recent audits.
• Reflect changes in regulatory and manufacturing environments and in the advanced technology in contamination control
• Incorporate principles of ICH Q9 Risk Management ICH Q10 Pharmaceutical Quality System and using this when taking advantage of the new possibilities by using innovative tools
• To correct inaccuracies and offer more detail to remove ambiguity
• Align this guideline with international requirements
• Clarify other areas of potential applicability of Annex 1 utilizing QRM principles
The new Annex 1 has been significantly expanded, however there is room for interpretation when it comes to how to be compliant with the updated version. In this presentation we will provide an 'auditors view' on how to verify/challenge if companies are compliant with the updated Annex one, illustrated by sharing experiences from recent audits.
1115 – 1145
Pharma 4.0 Case Studies and Lessons Learned
Lukas Markwalder, Capgemini
Hans Otto Weinhold, AVEVA GmbH
Bernd Sessler, Roche
Global Industrial Data Hub for rapid Pharma 4.0 Manufacturing Transformation.
The Roche Lighthouse Project showcases the benefits of a joint approach by Pharma (Roche), Software Vendor (AVEVA) and Consulting Company (Capgemini) to seamlessly integrate a new Cloud Data Hub integrating global Manufacturing Data pipelines and rapidly develop scalable Visualization and Analytics Solutions within less than 6 months. The primary business objectives of this Lighthouse engagement were to align the new cloud based industrial data hub with Roche’s business needs, focusing on 3 key use cases:
1.Data Mesh: seamless integration of global data sources on the injection side and various fit for purpose visualization and analytics tools on the consumption side. This makes data widely available to enterprise consumers via tools like Aveva Advanced Analytics, Seeq, Dataiku via Snowflake (Enterprise Datahub), etc.
2.Digital Maintenance – use analytics to reduce downtime and make maintenance more condition based and cost efficient.
3.Net production time: analysis to showcase optimized equipment utilization and operational efficiency.
The Roche Lighthouse Project showcases the benefits of a joint approach by Pharma (Roche), Software Vendor (AVEVA) and Consulting Company (Capgemini) to seamlessly integrate a new Cloud Data Hub integrating global Manufacturing Data pipelines and rapidly develop scalable Visualization and Analytics Solutions within less than 6 months. The primary business objectives of this Lighthouse engagement were to align the new cloud based industrial data hub with Roche’s business needs, focusing on 3 key use cases:
1.Data Mesh: seamless integration of global data sources on the injection side and various fit for purpose visualization and analytics tools on the consumption side. This makes data widely available to enterprise consumers via tools like Aveva Advanced Analytics, Seeq, Dataiku via Snowflake (Enterprise Datahub), etc.
2.Digital Maintenance – use analytics to reduce downtime and make maintenance more condition based and cost efficient.
3.Net production time: analysis to showcase optimized equipment utilization and operational efficiency.
1145 – 1215
Pharma 4.0 Case Studies and Lessons Learned
Joel Fidalgo, NextPharma
Michelle Vuolo, Tulip Interfaces
Pharma has not yet fully experienced the paradigm changes that most other industries have gone through, and it shows. Imagine the impact of deploying digital solutions in your operations — enabling you to experience an order-of-magnitude increase in quality levels while also decreasing the Cost of Quality.
This session will tell the story of how NextPharma adopted a frontline operations platform as their digital solution for maintaining compliance and quality in their processes. Throughout their digital transformation journey, NextPharma learned that digital solutions should not be focused solely on automation but could also be used to augment their human workforce. By building simple digital apps that provided operators with step-by-step guidance for completing each process, they were able to increase quality, and provide information more readily to the necessary pharmacists. This new method resolved the compliance need for pharmacists to be in close proximity to the process, providing a digital twin of the process that is visible from anywhere in the facility with rich data. The digital solution, which can be easily scalable across NextPharma’s sites, supports the human workforce in achieving better quality and control of processes, helping to maintain patient safety.
This session will tell the story of how NextPharma adopted a frontline operations platform as their digital solution for maintaining compliance and quality in their processes. Throughout their digital transformation journey, NextPharma learned that digital solutions should not be focused solely on automation but could also be used to augment their human workforce. By building simple digital apps that provided operators with step-by-step guidance for completing each process, they were able to increase quality, and provide information more readily to the necessary pharmacists. This new method resolved the compliance need for pharmacists to be in close proximity to the process, providing a digital twin of the process that is visible from anywhere in the facility with rich data. The digital solution, which can be easily scalable across NextPharma’s sites, supports the human workforce in achieving better quality and control of processes, helping to maintain patient safety.
1145 – 1215
Annex 1 Implementation & Pharma 4.0
Matthias Kress, BioGrasp GmbH
James Sunna, Theos-CES GmbH
In this presentation, we explore the advanced stage of Pharma 4.0 maturity and the benefits of adopting a fully data-centric architecture. Currently, pharma companies face challenges in meeting information demands within a QbD (Quality by Design) framework due to system boundaries and complex data pathways. A data-centric approach, where data exchange and management are separated from computation and decision-making, can overcome these issues. We demonstrate the effectiveness of this approach through showcasing a QbD use case, focusing on an aseptic filling scenario to align with the conference's Annex 1 focus. The second part of the presentation addresses the requirements for implementing data-centric architectures. It emphasizes the need for a data architecture framework tailored to the pharmaceutical domain and adopting established standards like ISA95 and ISA88. We introduce a preliminary framework developed to align with proposed principles from our concept paper.
1215 – 1345
Networking
1345 – 1415
Annex 1 Implementation & Pharma 4.0
Carl-Helmut Coulon, PhD, INVITE GmbH
Bill Rusitzky, SRI International
Annex1 requires minimizing human intervention in critical areas such as fill and finish operation. Robot Telemanipulation allows a person to control robot arms from outside the sterile or hazardous environment. On a daily basis Robot Telemanipulation enables Robotic Surgery and bomb disposal. In Pharma manufacturing, today tasks that cannot be efficiently automated, require human intervention, often placing the pharmaceutical product or the operator at additional risk.
The advancement in robotic telemanipulation permits individuals to perform manual interventions without entering sterile or hazardous areas. With stereo 3D vision, operators have a lifelike view of the environment, while telemanipulation software empowers precise control over robotic arms, akin to how surgeons operate with robotic surgery today.
Today Robot telemanipulation is being used by large Pharma companies to test use cases and plan operational rollout, minimizing human interaction with the sterile and hazardous areas.
The telemanipulation systems will also have additional benefits including the ability to record data and the 3D video enabling complete documentation of the interventions.
The advancement in robotic telemanipulation permits individuals to perform manual interventions without entering sterile or hazardous areas. With stereo 3D vision, operators have a lifelike view of the environment, while telemanipulation software empowers precise control over robotic arms, akin to how surgeons operate with robotic surgery today.
Today Robot telemanipulation is being used by large Pharma companies to test use cases and plan operational rollout, minimizing human interaction with the sterile and hazardous areas.
The telemanipulation systems will also have additional benefits including the ability to record data and the 3D video enabling complete documentation of the interventions.
1345 – 1415
Pharma 4.0 Case Studies and Lessons Learned
Michelangelo Canzoneri, Merck KGaA Darmstadt, Germany
Giuseppe Menin, Ing. Punzenberger COPA-DATA GmbH
Speeding up and Simplifying Modular Equipment Connectivity in Labs/Production
Merck KGaA has discovered a key success factor in modular production through the implementation of the Module Type Package (MTP) standard (VDI/VDE/NAMUR 2658). MTP is an innovative approach that enables seamless communication across all equipment within a central control system, overcoming the challenges posed by a fragmented hardware and software landscape.
By encapsulating individual work steps into modules, researchers can quickly and repeatedly assemble these into new applications and processes using graphical tools, without needing programming expertise. This concept of "Plug & Produce" is further enhanced by the introduction of a central software platform known as the Process Orchestration Layer (POL), which automatically integrates all instrument functions as MTP modules (Process Equipment Assembly - PEA).
Key benefits include:
•Automation of Operations: The primary role of the workforce in labs and operations is emphasized, allowing them to focus on their tasks rather on than the manual integration of devices or transferring experiment data into flat Excel files.
•Paperless Operations: Process values, measurements, deviations, and execution logs are stored electronically, eliminating the need for manual records.
•Fast Reconfiguration and Tech Transfer: Scaling up processes from laboratory to commercial manufacturing is streamlined, requiring no manual adjustments.
The presentation will provide an overview of the project timeline, from the pilot phase to the full automation of 600 modules according to the MTP standard. We will also showcase a video demonstrating the steps a laboratory engineer takes to reconfigure an experiment setup, from integrating "MTP ready" modules to process orchestration and control application generation to execution. This will offer a clear understanding of the practical application and benefits of this technology.
Merck KGaA has discovered a key success factor in modular production through the implementation of the Module Type Package (MTP) standard (VDI/VDE/NAMUR 2658). MTP is an innovative approach that enables seamless communication across all equipment within a central control system, overcoming the challenges posed by a fragmented hardware and software landscape.
By encapsulating individual work steps into modules, researchers can quickly and repeatedly assemble these into new applications and processes using graphical tools, without needing programming expertise. This concept of "Plug & Produce" is further enhanced by the introduction of a central software platform known as the Process Orchestration Layer (POL), which automatically integrates all instrument functions as MTP modules (Process Equipment Assembly - PEA).
Key benefits include:
•Automation of Operations: The primary role of the workforce in labs and operations is emphasized, allowing them to focus on their tasks rather on than the manual integration of devices or transferring experiment data into flat Excel files.
•Paperless Operations: Process values, measurements, deviations, and execution logs are stored electronically, eliminating the need for manual records.
•Fast Reconfiguration and Tech Transfer: Scaling up processes from laboratory to commercial manufacturing is streamlined, requiring no manual adjustments.
The presentation will provide an overview of the project timeline, from the pilot phase to the full automation of 600 modules according to the MTP standard. We will also showcase a video demonstrating the steps a laboratory engineer takes to reconfigure an experiment setup, from integrating "MTP ready" modules to process orchestration and control application generation to execution. This will offer a clear understanding of the practical application and benefits of this technology.
1415 – 1445
Annex 1 Implementation & Pharma 4.0
Christian Scarpato, Merck Serono S.P.A.
Designing an APS that accurately mirrors the complexities of lyophilization is a formidable task. However, adapting certain aspects of the process using scientific rationales and risk-based approach, it is possible to devise an APS plan that closely mimics routine aseptic lyophilization while ensuring the viability and recovery of contaminants.
1415 – 1445
Pharma 4.0 Case Studies and Lessons Learned
Marcel Kraft, Bayer
A rapid and resource-efficient synthesis of new drug candidates in chemical-pharmaceutical research is of crucial importance for the successful development of new drugs.
By specifically adapting the reaction conditions can be enabled or yields can be optimized. The search for optimal reaction conditions is the task of catalyst screening labs, which today already work in a highly parallel and automated manner with high-throughput experimentation in all research-based pharmaceutical companies. However, there is still significant optimization potential in the area of digitization of workflows, from campaign planning to the control of robot systems to the automated evaluation of the screens and the seamless integration of modern AI methods for predicting optimal conditions. Based on the ongoing works in the Catalyst Screening Lab in the Bayer R&D Center in Wuppertal, this work presents a comprehensive investigation of the possible uses and limitations of automated workflows in chemical research, especially but not limited to the context of HTE in catalyst screening. The collected data and analyses of these provide several key insights into the following questions:
- How can historical laboratory data be prepared for machine learning and what value does it represent?
- What might be a pragmatic approach to integrating AI into an automated laboratory?
- What problems exist with AI models and how can they be overcome with an interdisciplinary approach (Engineering perspective)?
- How much effort is involved in holistic digitization of HTE laboratory workflows and what are the benefits?
- How ca engineering make in impact in R&D workflows?
By specifically adapting the reaction conditions can be enabled or yields can be optimized. The search for optimal reaction conditions is the task of catalyst screening labs, which today already work in a highly parallel and automated manner with high-throughput experimentation in all research-based pharmaceutical companies. However, there is still significant optimization potential in the area of digitization of workflows, from campaign planning to the control of robot systems to the automated evaluation of the screens and the seamless integration of modern AI methods for predicting optimal conditions. Based on the ongoing works in the Catalyst Screening Lab in the Bayer R&D Center in Wuppertal, this work presents a comprehensive investigation of the possible uses and limitations of automated workflows in chemical research, especially but not limited to the context of HTE in catalyst screening. The collected data and analyses of these provide several key insights into the following questions:
- How can historical laboratory data be prepared for machine learning and what value does it represent?
- What might be a pragmatic approach to integrating AI into an automated laboratory?
- What problems exist with AI models and how can they be overcome with an interdisciplinary approach (Engineering perspective)?
- How much effort is involved in holistic digitization of HTE laboratory workflows and what are the benefits?
- How ca engineering make in impact in R&D workflows?
1445 – 1515
Annex 1 Implementation & Pharma 4.0
Geert Vandenbossche, PhD, C&E Solutions BV
Radio Ligand Therapy (RLT) production has evolved from research to clinical and commercial applications, requiring strict adherence to Annex-1 standards, while still assuring radioprotection of production operators. Basic advancements include separating synthesis, sterile compounding, aseptic filling and crimping. Several activities require unprecedented challenges: visual inspection and labelling of radioactive, individualized vials, but also filter integrity testing, leak testing and environmental monitoring of a radioactive environment in negative pressure requires extra precautions.
1445 – 1515
Pharma 4.0 Case Studies and Lessons Learned
Lasse Harloff-Helleberg, NovoNordisk
Bjarke Primdal-Bengtson, Novo Nordisk
In the pharmaceutical industry, the release of batches is a critical step in ensuring product quality and compliance with regulatory requirements. However, this process can be time-consuming, error-prone, and fragmented across multiple departments and systems.
To address these challenges, Novo Nordisk has implemented a global digital solution that enables the display of batch-related data and facilitates the evaluation, identification, and conclusion of any needed actions by QA.
This session will focus on key features, benefits, and implementation considerations of this digital solution for batch release, which has been crucial for optimization of the batch release process to our patients.
To address these challenges, Novo Nordisk has implemented a global digital solution that enables the display of batch-related data and facilitates the evaluation, identification, and conclusion of any needed actions by QA.
This session will focus on key features, benefits, and implementation considerations of this digital solution for batch release, which has been crucial for optimization of the batch release process to our patients.
1515 – 1530
Networking
1530 – 1600
This presentation will provide a status update on the development Quality Innovation Group (QIG) document.
1600 – 1630
General Session
Giampiero Lorenti, PhD, European Medicines Agency
The presentation will focus on the EMA Quality Innovation Group (QIG) and its activities to support the translation of innovative approaches to the design, manufacture and quality control of medicines, to bring new therapies and help improve the supply of existing medicines to patients.
1630 – 1645
General Session
Laura Kuger, Takeda
Teresa Minero, LifeBee - Digitalizing Life Sciences
1645 – 1700
0800 – 1300
Facility Tour
This facility tour is sold out and will not be accepting additional registrants.
BSP is a CDMO focused on innovative cytotoxic and non-cytotoxic products for oncology, immuno-oncology, CNS, and other relevant therapeutic indications. Attendees will tour the Sterile Pharmaceuticals Departments and Conjugation Department.
Transportation and Lunch are provided! To reserve your spot, be sure to add this to your registration for $75. Attendance is limited to 20.
Important Notice: Employees of CMOs and CDMOs are not allowed to attend this facility tour per the host facility’s policies.
Attendees will be required to sign a confidentiality agreement. No photos are permitted.
BSP is a CDMO focused on innovative cytotoxic and non-cytotoxic products for oncology, immuno-oncology, CNS, and other relevant therapeutic indications. Attendees will tour the Sterile Pharmaceuticals Departments and Conjugation Department.
Transportation and Lunch are provided! To reserve your spot, be sure to add this to your registration for $75. Attendance is limited to 20.
Important Notice: Employees of CMOs and CDMOs are not allowed to attend this facility tour per the host facility’s policies.
Attendees will be required to sign a confidentiality agreement. No photos are permitted.
0830 – 1630
Separate registration required. To learn more and register for this 2-day course, visit this link: https://ispe.org/conferences/2024-pharma-40-annex-1-conference/training
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
0830 – 1300
Facility Tour
The Pharmaceutical Manufacturing Unit of the Bambino Gesù Pediatric Hospital is one of the largest, most active, and productive pharmaceutical facilities in Europe. It's a sterile environment where advanced therapy drugs and new biotechnological drugs are produced. These drugs' active ingredients are made of cells, shifting the focus from medications for large populations to those for niche groups of patients. This represents personalized medicine and precision drugs to treat cancers and other conditions.
During the visit, attendees will tour the facility under the guidance of the scientific director and the medical director. The sterile laboratories (microbial strain collection laboratory and microbiological laboratories) will be visible from the outside through windows. Visitors will also tour the quality control and gene therapy departments.
Transportation is provided. To reserve your spot, be sure to add this to your registration for $75 or stop at the onsite registration desk. Attendance limited to 50.
Important Notice: No videos or photos allowed. Visitors with a fever or any ongoing illness on the day of the visit will not be permitted to participate. Any luggage, umbrellas, or other bulky items must be left outside.
During the visit, attendees will tour the facility under the guidance of the scientific director and the medical director. The sterile laboratories (microbial strain collection laboratory and microbiological laboratories) will be visible from the outside through windows. Visitors will also tour the quality control and gene therapy departments.
Transportation is provided. To reserve your spot, be sure to add this to your registration for $75 or stop at the onsite registration desk. Attendance limited to 50.
Important Notice: No videos or photos allowed. Visitors with a fever or any ongoing illness on the day of the visit will not be permitted to participate. Any luggage, umbrellas, or other bulky items must be left outside.
Hear From Top Industry Thought Leaders on the Challenges and Solutions Impacting the Pharmaceutical Industry
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.