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.