Exploring the Future of ATMP Manufacturing from Digitalization to Navigating Regulations
In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the 2024 ISPE Pharma 4.0™ and Annex 1 Conference, taking place 10-11 December in Rome, Italy, and virtually, will feature a track titled, "How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation." This track will bring together experts from various fields to discuss the integration of digital technologies and regulatory frameworks in the development journey of ATMPs, as well as provide insights into real world implementation data and lessons learned. With a focus on enhancing compliance, efficiency, and accessibility, the track will feature six engaging talks and provide attendees with valuable insights into the future of this rapidly evolving sector.
As the industry shifts from manual operations in Grade A environments to fully automated systems in lower-grade settings, closed system technology emerges as a pivotal factor. The first presentation, “Is Closed Processing for ATMPs a Risk?” will be provided by David Estapé with CRB Group GmbH. The session will address the regulatory acceptance of these advancements, and the role digitalization plays in enhancing closed processing, ultimately shaping the future of ATMPs accessibility.
Following this, participants have the chance to explore the digital transformation of ATMP facilities with a comprehensive overview from Kees Mensch with NecstGen. Their presentation, “Digital ATMP Setup: Roadmap, Insights, and Key Lessons,” will highlight the guiding principles and cultural shifts necessary for a successful digital setup and illustrates how digital integration reduces operational costs, enhances flexibility, and ultimately lowers product prices.
The next session, “Global Digitalization of Contamination Control System” will transfer the audience’s focus to the global digitalization of contamination control systems, featuring insights from Boehringer Ingelheim's six-year project. This talk, presented by Martin Müllner with Boehringer Ingelheim and Susan Cleary with Novatek International, will cover the challenges faced during the rollout of a digital contamination control system across multiple sites. Attendees can learn about the harmonization of processes, the lifecycle of the system, and how digital tools have significantly reduced incidents while ensuring compliance with Annex 1 regulations.
After a short networking break, Paul Fiorio with Bayer will address the implementation of EU GMP Annex 1 requirements for critical starting materials and gene editing reagents in ATMP manufacturing. The presentation will provide attendees with a clear understanding of how to navigate the complexities of regulatory compliance and describes a practical example of implementation in enzymatic DNA manufacturing.
Afterward, Laurens Vergauwen with Merck will introduce an innovative approach in the session, “Using Raman Spectroscopy in MRNA Manufacturing.” The data-driven case study will illustrate how this non-destructive analytical tool addresses the limitations of traditional quantification methods and optimizes the in vitro transcription process, enhancing efficiency in mRNA production.
Finally, the ATMP track’s final session will be shaped by a dynamic conversation, presented by Francesco Cicirello with BioNTech US Inc. and Sharlene Lugo with BioNTech SE. The presentation will focus on the applicability of Annex 1 to ATMPs, “Conversations on Annex 1 and ATMPs, Quality by Design (QdD) and Modular Manufacture.” The audience can address questions about Quality by Design and modular manufacturing.
Why attend
Agencies, manufacturers, contract manufacturing organizations, and other solution providers have shown a great level of commitment over the last years to contribute to the maturity of the ATMP industry, and yet, standards and best practices on solving the specific issues this industry faces are still missing. This track on "How ATMPs Manufacturing can be Supported by Annex 1 and Digital Transformation" is a great opportunity for industry leaders involved in the ATMPs landscape to gather and learn from each other’s experiences in overcoming challenges like the complexity of process execution, enhanced supply chain requirements, and interdependent data flow orchestration. All presentations of the track focus on specific challenges in the ATMP industry and describe solutions that have been found in Pharma 4.0, as well as sharing lessons learned along the path. Thus, the conference will provide the perfect opportunity to pave the way for a future where ATMP manufacturing is not only compliant with regulatory standards but also driven by innovative digital solutions.
