Journal of pharmaceutical sciencesDec 18, 2024

New methods for drying and making stable solid forms of mRNA and siRNA lipid nanoparticles

mRNA Technology Weekly Brief ↗PubMed ↗DOI ↗

Updated Mar 17, 2026

Abstract

Current RNA lipid nanoparticle (LNP) formulations require ultra-cold storage for stability.

Drying processes, such as lyophilization and spray drying, may enhance stability and allow for room temperature storage.
The choice of drying technique is influenced by delivery mode, lipid components, and desired characteristics of the final product.
Factors contributing to instability during drying need to be understood to optimize formulation stability.
Process parameters related to formulation and manufacturing environment can affect the final attributes of solid-state products.
Attributes like appearance, moisture content, and reconstitution time are associated with the physical and chemical stability of RNA/LNP formulations.

Simplified

Current RNA lipid nanoparticle (LNP) based products are typically liquid formulations that require ultra-cold storage temperatures for stability. To address this limitation, recent efforts have focused on enhancing stability and enabling room temperature storage by converting these formulations into solid forms through drying processes such as lyophilization, spray drying, and spray-freeze drying. Nevertheless, the drying process itself can influence the stability of RNA/LNP formulations. Therefore, understanding the factors that contribute to instability during drying is essential. The choice of drying technique for LNPs depends on factors such as the mode of delivery, lipid components, and desired final product characteristics. Additionally, the drying mechanism and associated stresses must also be carefully considered. Drying methods involve a range of process parameters related to formulation, process settings, and the manufacturing environment. It is essential to understand how these parameters influence the final solid-state products' attributes, including appearance, moisture content, flow properties, and reconstitution time, as these can significantly affect the physical and chemical stability of the formulation. This review focuses on various drying techniques and their impact on the stability of RNA/LNP-based systems.

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New methods for drying and making stable solid forms of mRNA and siRNA lipid nanoparticles

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