Overcoming Formulation Challenges for mRNA and High-Concentration Proteins
Summary: In recent years, the industry witnessed new demand for protein delivery and the emergence of advanced modalities, such as mRNA. However, their development is met with technical challenges, including high-concentration formulations, stability and degradation. To address those concerns, optimizing formulation components, including high-throughput analytics methods, automation, statistical approach, and excipient design can help. In this article, experts provide an overview of current challenges associated with high-concentration protein formulations and in formulating mRNA lipid nanoparticles (mRNA-LNP) and how to overcome them.