Quality Control of mRNA/LNP Products

Background & Objectives

Innovations in cell therapy have transformed the pharmaceutical and biotechnology industries, creating new opportunities to treat previously incurable diseases. One of the key challenges in this field has been the reliance on viral transduction methods, which, while effective, have limitations such as scalability constraints, high production costs and potential immunogenicity. To overcome these hurdles, virus-free transduction technologies have emerged as a viable alternative, offering safer, more efficient and scalable solutions for cell engineering.

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 Audience

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

Register now

Moderation

Dr Sabine Hauck,Chair of the ECA ATMP Board
Dr Thomas Meindl, Labor LS

Programme

Microbiological Insights into the Analytical Life Cycle of mRNA-based Therapeutics
Dr Stefanie Bayer, Labor LS

• Are mRNA products predestined for platform analytics?
• Why is microbiological QC on mRNA different to microbiological QC on traditional Products?
• Which regulatory guidelines are relevant?
• Examples of adapted microbiological QC methods: test of Cell banks, bioburden, test of sterility, test of Endotoxins, test of Mycoplasma, including validation approaches

Building a Robust CMC Framework for mRNA Therapeutics: From Raw Materials to Drug Product Release
Dr Mohamad Toutounji, Molgenium

• Overview of regulatory requirements and GMP aspects in the development of mRNA drugs
• Critical quality attributes (CQAs) and analytical methods along the manufacturing process
• Identification and control of critical process parameters (CPPs) in IVT and LNP manufacturing
• Challenges in scale-up, stability testing and technology transfer

CMC Strategies for saRNA Therapeutics: Optimizing T7 Polymerase, IVT Processes, and Quality Control to Accelerate Clinical Translation
Mengqian Mao, Novoprotein

• Introduction: saRNA Therapeutics & CMC Challenges & Production
• IVT Process: From Bench to GMP
• Quality Control: Meeting Regulatory Standards
• Integrated CMC Workflow: Case Study
• Regulatory & Commercial Considerations

Setting up Specifications: Considerations and Approaches
Dr Jan M. Falcke, BioNTech

• Current state of art (overview)
• Specification setting and control strategy
• Considerations on patient centric specifications

Homing In on Fit-for-Purpose Biophysical Techniques for mRNA and LNP Characterization
Dr Natalia Markova, Freelance Consultant

• Challenges in mRNA-LNP product and process understanding
• Novel and repurposed biophysical techniques for mRNA and LNP characterization
• Emphasis on approaches with stability-indicating potential

Endotoxin Detection via a Low-Cost Electrochemical Test Strip and Reader Approach
Prof Dr Damion Corrigan, Aureum DX

• Introduce the electrochemical measurement which underpins the endotoxin testing technology
• Describe the test strip layout and sensor manufacturing processes
• Introduce the multichannel reader built to underpin the endotoxin measurement
• Show performance level for a range of commercially available rCR reagents on the platform
• Show endotoxin detection data from a range of samples and matrices

Case Studies for mRNA Therapeutics – Developing Reliable and Robust Potency Methods
Dr Frances Reichert, Eurofins

• Cell-based potency assays for determination of mRNA functionality
• Practical insights into the development of robust mRNA potency/expression assays
• Critical role of statistical analysis in potency determination

mRNA Products as ATMP and as Vaccine - Same Technology but Different Requirements
Dr Sabina Hauck, dequra pharma consult hauck

• Requirements of Pharm. Eur. general monograph 3186 for mRNA/LNPs
• The requirements for mRNA vaccines and GTMP side-by-side