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 Summer Time (CEST). Find your personal viewing time on the World Clock.
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General Session
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Pharma 4.0 Interconnected Facility Design and Construction
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Annex 1 Implementation & Pharma 4.0
Tue, 10 Dec
Wed, 11 Dec
0900 – 0910
General Session
Michael Rutherford, ISPE
0910 – 0930
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.
0930 – 0950
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.
0950 – 1010
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.
1010 – 1020
General Session
Line Lundsberg-Nielsen, NNE
Richard Denk, SKAN AG
1100 – 1110
General Session
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
Christopher 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.
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.
1400 – 1430
Pharma 4.0 Interconnected Facility Design and Construction
Charles Heise, 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.
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.
1635 – 1700
Pharma 4.0 Interconnected Facility Design and Construction
Dominik Rabus, PhD, RABUS.TECH
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.
0900 – 0905
0905 – 0910
General Session
0910 – 1000
General Session
Laura Kuger, Karlsruhe Institute of Technology (KIT)
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.
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.
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.
1345 – 1415
Annex 1 Implementation & Pharma 4.0
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.
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.
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.
1530 – 1630
General Session
1630 – 1645
General Session
Laura Kuger, Karlsruhe Institute of Technology (KIT)
Teresa Minero, LifeBee - Digitalizing Life Sciences
1645 – 1700
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.