Programme

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Technical PresentationLive-streamed education sessions.
Day 1
Wednesday, 7 December 2022
Day 2
Thursday, 8 December 2022
  • 0730 - 0830
    Work-Life Balance - Presented by Women in Pharma™
    Join us for a roundtable discussion focused on Work-Life Balance where attendees can discuss experiences to encourage the development of relationships and the sharing of ideas and professional advice. The format will be interactive roundtable discussion style with questions and topics at each table.
  • 0900 - 0930
    Annex 1, EudraLex Volume 4: Where are we regarding the time to implementing the new requirements?
    Speakers

    Jörg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
  • 0900 - 0930
    Setting the Stage for eData Exchange
    Speakers

    Stephen Wing

    Head of Analytical & Logistical Services
    Merck KGaA
    Presentation Information
    [Setting the Stage for eData Exchange]
    Many biopharmaceutical and pharmaceutical manufacturers have been planning and investing in various digital technologies to drive business improvements, in order to better serve and meet the growing demands for new and better therapies around the world. The advancement of new digital technologies and capabilities provides many opportunities to implement various types of solutions across the enterprise. One major aspect of implementing successful digital transformation projects is the ability to share and use electronic data in a seamless fashion. This talk will focus specifically around the key success factors for sharing of raw material digital data between suppliers and biopharmaceutical and pharmaceutical manufacturers. The presentation will also provide an overview of some of the major considerations, which need to be addressed for short-term impact but also for long-term sustainability and viability.
  • 0930 - 1000
    Single-Use Systems Characterisation – How Standardised Extractables Data Support E&L Risk Assessment
    Speakers
    Presentation Information
    [Single-Use Systems Characterisation – How Standardised Extractables Data Support E&L Risk Assessment]

    Since Single-Use Systems (SUS) and plastic materials are widely adopted in biopharmaceutical industry, their characterization is essential to ensure patients’ safety and, as end-users, drug manufacturers have to assess the safety risk linked to the presence of these materials along the production stream. One of the most important parts of the risk assessment is the E&L assessment, which is performed on the extractables data available for all materials involved. For these reasons, SUS/PCI suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables information, defining standardized procedures (in terms of extraction procedures and analytical techniques) to generate extractables data package. This talk will give an overview of the Risk assessment and the E&L assessment workflow from the drug manufacturers perspective, in accordance with the regulatory expectations and the upcoming USP requirements. Case studies on “deviations from RA outcomes” will be presented, highlighting the importance of the analytical expertise and support by mean of state-of-the-art technology as well as the role of the collaboration between suppliers, drug manufacturers and toxicologists. Areas of interest will include: - Regulatory expectations on risk assessment and upcoming USP requirements - Drug manufacturers point of view on how to perform risk assessment and relevant workflow - E&L risk evaluation - E&L analytical investigations – case studies - The importance of toxicological evaluation in the overall process - Challenges, points for improvement
  • 0930 - 1000
    Revolutionizing Visual Inspection through Artificial Intelligence
    Speakers

    Mario Holl

    Vice President Product, Sales & Relations
    InspectifAI
    Presentation Information
    [Revolutionizing Visual Inspection through Artificial Intelligence]
    Visual inspection of pharmaceutical products is an important step to ensure drug quality and patient safety. Even though the process of visual inspection is taken over by fully-automatic inspection machines, traditional rule-based methods are used in the inspection task leading to certain disadvantages in terms of necessary re-inspection of falsely-declared bad products. This leads to costs in the range of millions. With AI-based methods the knowledge of inspection experts can be condensed in a technical structure (so called neural net) which is implemented into the fully-automatic inspection machine to make the better inspection decision. Results prove this and shows that the detection rate (the probability that a defect unit is identified as defect – quality improvement) as well as the false-eject rate (the probability that a good unit is identified as defect – cost reduction) can be optimized at the same time and makes AI accessible independent from the specific inspection machine vendor.
  • 1000 - 1030
    New Annex 1 Challenges for LVP Bag Manufacturing
    Speakers

    Daniel Boergel

    Director Microbiology & Aseptic Technique | Quality Management Generics
    Fresenius Kabi Deutschland GmbH
    Presentation Information
    [New Annex 1 Challenges for LVP Bag Manufacturing]
    Flexible plastic containers (LVP and SVP bags), filled with Standard Solutions (often used as carrier to administer other medication) and Nutritional Products are an important backbone of hospital care for critically and chronically ill patients. Manufacturing those flexible plastic containers (single and multi-chamber bags that typically contain an additional over-pouch) requires good process design, process robustness and control of critical process parameters, particularly for parameters relevant to container integrity. In the new Annex 1, SVP bags are added to the list of “containers closed by fusion” that will require 100 % Container Closure Integrity Testing (CCIT) as a final product control. Implementing a 100 % CCIT technology for filled flexible containers presents unique technical challenges and is in contrary to the recent years industry development towards Process Analytical Technology (PAT), representing a return to an end-product testing approach which may not lead to improved leakage detection. Integrity testing technologies enabling a full integration into manufacturing lines and having suitable sensitivity & speed, first need to be developed (taking several years, with no guaranteed success). For existing manufacturing lines, integration of such a technology may not be feasible and for some bag types, as i.e., the multi-chamber-bags, no suitable 100 % technologies may be found.
  • 1000 - 1030
    Standardized Integration for Lab Robots
    Speakers
    Presentation Information
    [Standardized Integration for Lab Robots]
    The complexity of laboratory automation systems is ever-increasing both in the aspect of the workflows and in the aspect of the corresponding technological components. A systematic approach will be presented that outlines a hierarchical – layer-by-layer – distinction for both of these aspects. On the technological side, concrete standardized solutions will be discussed and proposals will be formulated for a comprehensive digital-twin based framework. The focus will be laid on lab robots, whose primary scope of application in the state-of-the-art is labware transportation. Considerations will be provided for extending these capabilities with the latest advancements in robotics technologies.
  • 1030 - 1100
    Networking Break in the Exhibition Area (Foyer)
  • 1100 - 1130
    Speakers
    Presentation Information
    [Pharma 4.0™ 6th Survey: Latest Results and Trends]
    The Pharma 4.0™ Survey is at its 6th edition and the aim is to get the ISPE Pharma 4.0 SIG yearly update on the state of the art, the goals, the mindset and also the sentiment about 4.0 from the Life Science protagonists. Previous editions have been carried out since 2017, having always around 300 to 400 respondents. We have received meaningful results appreciated by the whole industry, the vendor ecosystem and also by the regulators. Changing with the evolving reality, this edition presents a more structured and focalized set of questions along with a review of the topics suggested from the latest and current events, mainly with reference to concerning benefits and particularly related to Quality and Compliance, as requested by Regulators during our 2022 Annual Conference.
  • 1130 - 1230
    Regulatory Panel: Annex 1 Implementation
    The updated Annex 1 has been released end of August, introducing changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. In this panel, Regulators will discuss those changes and how they impact our manufacturing practices and consider how Pharma 4.0ÿ concepts such as data management and clean room monitoring can assist with Annex 1 implementation. More work is now needed to bring clarification which could be needed in the future for a better implementation of this new document, training for all stakeholders and regulators will be needed to have an harmonized application of the new Annex 1.
    Session Leaders
    Speakers

    Rick Friedman

    Deputy Director, Office of Manufacturing Quality
    CDER/FDA
  • 1230 - 1330
    Lunch and Networking Break in the Exhibition Area (Foyer)
  • 1245 - 1330
    Reflection - Presented by ISPE Women in Pharma™
    Join us for a roundtable discussion focused on Reflection where attendees can discuss and reflect on their experiences to encourage the development of relationships and the sharing of ideas and professional advice. The format will be interactive roundtable discussion style with questions and topics at each table.
  • 1330 - 1400
    Regulatory View on the Holistic Control Strategy and Digital Maturity
    Speakers
    Presentation Information
    [Regulatory View on the Holistic Control Strategy and Digital Maturity]
    Regulation has a powerful impact on innovation: it can stimulate ideas and can block their implementation. Given this, how much do regulators understand and support Pharma 4.0 initiatives and how will they regulate this area in the future? This session will explore the role regulators can play in advancing innovation, look at examples where not doing so has held back developments, and also focus on how regulators globally view Pharma 4.0 initiatives differently.
  • 1330 - 1400
    MIVAREP, an Innovative Percutaneous Valve: A Production Challenge for Pharmacy Students
    Speakers
  • 1400 - 1430
    The Road to Operational Readiness Through the Lens of Digitization and Process Knowledge Management
    Speakers
  • 1400 - 1430
    Real Time Environmental Monitoring
    Speakers
    Presentation Information
    [Real Time Environmental Monitoring]

    Biofluorescent Particle Counters (BFPC) are an alternative microbiological method that can serve as the solution for Annex 1 compliance and Pharma 4.0 implementation. Unlike culture-based microbiology, BFPC use Laser Induced Fluorescence to provide fully automated, real-time, and continuous viable air monitoring capabilities. This provides the process understanding, without added risk, that Annex 1 is encouraging. When coupled with OPC UA, an open communication platform, this data can easily be connected with other process data to achieve the improved process control that Pharma 4.0 is designed to achieve. This presentation will provide an introduction to how BFPC can be installed and utilized for the real time monitoring of viable and total particles in an aseptic environment. An overview of the data that is generated through this testing, and how that data can be connected with other data via OPC UA, will be reviewed.
  • 1430 - 1500
    Chartering a Holistic Path to Deliver Transformational Value at Scale for Pharma 4.0
    Speakers
    Presentation Information
    [Chartering a Holistic Path to Deliver Transformational Value at Scale for Pharma 4.0]

    In this session BCG’s James Morton and CRB’s Yvonne Duckworth lay out what it takes to deliver real value by building the foundations to enable you to scale digital across your whole network at pace. Covering examples of greenfield builds and legacy site augmentation and how you can combine the two as part of a holistic digital programme. The session will introduce a framework of six pillars, 3 optimisation pillars that drive the value and 3 foundational elements that enable the scaling of digital to ensure this value is accessed across the network and not just in isolated ‘proof of concept’ locations.
  • 1430 - 1500
    A Step Towards Human-less Continuous Environmental Monitoring
    Speakers
    Presentation Information
    [A Step Towards Human-less Continuous Environmental Monitoring]
    Presentation will cover the learnings and challenges by implementing and converting from CFU to AFU environmental monitoring systems by introducing Bio-Fluorescent Particle Counter technology.
  • 1500 - 1530
    Networking Break in the Exhibition Area (Foyer)
  • 1530 - 1600
    Digitalising an Aseptic Manufacturer: A Holistic Perspective to Build a Sound Roadmap
    Speakers

    Davide Ferrara

    Digital Affairs Corporate Executive Director
    Sintetica CIO (CH)
    Presentation Information
    [Digitalising an Aseptic Manufacturer: A Holistic Perspective to Build a Sound Roadmap]

    A Swiss medium size Aseptic Manufacturer has been undertaking an in-depth digital transformation program of the whole Company with 4.0 and digital solutions, aimed to reshape the processes and achieve modernization and high-level performances, in full and evolving compliance and with a great focus on Innovation considered as one of key pillar of the transformation program. Success factors of the roadmap and of consequent execution programs will be shared: from preliminary activities to outline a Strategic Digital Roadmap to right focus on Innovation Trends and overall Program Governance, from selection criteria for systems and solutions through the revision of Quality, Production and Laboratory processes to enable effective integration and increase agility.
  • 1530 - 1600
    Panel Discussion on Continuous Environmental Monitoring
    Speakers

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
  • 1600 - 1630
    Implementing Pharma 4.0
    Speakers

    Jordan R. Croteau

    Sr. Director, Manufacturing and Facilities Systems
    Moderna Therapeutics
    Presentation Information
    [Implementing 4.0]
    Moving beyond buzz words and technology trends, this session will focus on structuring a program to implement modular, harmonized, and integrated digital capabilities enabling efficient and effective digital manufacturing deployments – a mature digital manufacturing template. It will explore best-practices in unifying manufacturing operations data into a single source of truth, and other essential steps in the journey to becoming a truly globally integrated organization.
  • 1600 - 1630
    Engineering Changes and Solutions Approaching the New Annex 1 2022 in Existing Facilities
    Speakers
    Presentation Information
    [Engineering Changes and Solutions Approaching the New Annex 1 2022 in Existing Facilities]
    All the existing sterile manufacturing facilities will have to be compliant with the new Annex 1 requirements and contents. The presentation will introduce the main requirements and proposes solutions already implemented in existing facilities. Presentation’s focus will be case studies evaluating impact on Sterility assurance, budget and manufacturing efficiency; grade A continuity and freeze drying technology will be especially taken in consideration.
After the Event
Friday, 9 December 2022
  • 0900 - 1200
    Plant Tour: Takeda
  • 0900 - 1200
    Plant Tour: Living Lab - Siemens
    LivingLab @Siemens City Vienna The focus of the LivingLab Vienna is the digitalisation of process development and manufacturing production in the pharmaceutical industry. The combination of lab and showroom is a unique Industry 4.0 pilot plant, where visionary ideas can be tested and developed in a real environment. At the LivingLab Vienna we can demonstrate the domain and research know-how in bioprocesses. Based on “real-life” fermentation we use and demonstrate automation and digitalization solutions for the entire product and production life cycle: - DCS system - Electronic batch record for MES and recipe management - PAT application - Labor information and management system - Simulation solutions for process and production - Integrated engineering tool - Predictive maintenance - Edge & cloud applications