Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation
Tue, 10 Dec
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.
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.
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.
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
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, QbDD & 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?
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.