Objectives
At the forefront of these advances is the use of RNA-based methods, particularly mRNA and lipid nanoparticle (LNP) systems, which have reshaped therapeutic approaches across multiple disciplines. Unlike viral vectors, mRNA/LNP technologies allow precise and transient genetic modification without the risks associated with viral integration. Their rapid development and commercialization has highlighted the need for stringent quality control measures to ensure safety, efficacy and regulatory compliance.
As analytical technologies evolve, compliance with key regulatory standards such as the European Pharmacopoeia (Pharm. Eur.), the United States Pharmacopeia (USP) and Good Manufacturing Practice (GMP) guidelines is essential. The pre-conference track on Quality Control for mRNA/LNP Products will provide an in-depth overview of current quality control strategies, focusing on regulatory requirements, microbiological considerations and advanced analytical methods.
Industry leaders and regulatory experts will discuss the latest developments in quality assurance, covering topics such as advanced characterization techniques, stability testing and new analytical approaches. This track will serve as an important platform for knowledge exchange, fostering discussions on the evolving landscape of mRNA therapeutics and laying the groundwork for future innovation in the field.
Target Group
The Pre-Conference is directed to responsible personnel involved in Quality Control testing of mRNA or LNP based products, e.g.:
- QC and QA Managers
- Laboratory Managers
- Microbiologists, and Process Microbiologists
- Analytical & Technical Experts
- Regulatory Authorites
- R&D Professionals
Programme
Seminar Programme as PDF
Microbiological Insights into the Analytical Life Cycle of mRNA-based Therapeutics
Dr Thomas Meindl, Thermo Labor LS
Addressing mRNA vaccines in the European Pharmacopoeia - New Ph. Eur. Texts
Dr Thuy Bourgeois, EDQM - Council of Europe
Building a Robust CMC Framework for mRNA Therapeutics: From Raw Materials to Drug Product Release
Dr Mohamad Toutounji, Molgenium
CMC Strategies for saRNA Therapeutics: Optimizing T7 Polymerase, IVT Processes, and Quality Control to Accelerate Clinical Translation
Mengqian Mao, Novoprotein
Setting up Specifications: Considerations and Approaches
Dr Jan M. Falcke, BioNTech
Homing In on Fit-for-Purpose Biophysical Techniques for mRNA and LNP Characterization
Dr Natalia Markova, Freelance Consultant
Endotoxin Detection via a Low-Cost Electrochemical Test Strip and Reader Approach
Prof Dr Damion Corrigan, Aureum DX
Case Studies for mRNA Therapeutics – Developing Reliable and Robust Potency Methods
Dr Frances Reichert, Eurofins
mRNA Products as ATMP and as Vaccine - Same Technology but Different Requirements
Dr Sabina Hauck, dequra pharma consult hauck
| Regular Fee*: | € 690,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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Seminar Programme as PDF
