Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines

Wiley Interdisciplinary Reviews 

Authors: Gideon Kersten, Eleonora Cerasoli, Bruce Kerwin, Olivia M. Merkel,  Andrea Hawe

Lipid nanoparticles (LNP) are currently the most relevant non-viral delivery systems for mRNA and occasionally for smaller nucleic acids such as small interfering RNA. Although the manufacturing of LNP is well established and scalable equipment is available for production, LNP drug product development is not straightforward. Numerous factors influence product quality, including LNP composition, process parameters, and formulation composition. A proper understanding and control of the critical variables is essential for product development of LNP containing pharmaceuticals. This article provides an overview on the drug product development roadmap for LNP-based therapeutics and vaccines.

Read the full publication here: https://pubmed.ncbi.nlm.nih.gov/41761431/