Scaling up LNP formulation using a Reynolds number-based methodology
LNPs have become an essential enabling technology for RNA-based therapeutics and next-generation drug delivery systems. As these applications progress from laboratory research to commercial manufacturing, process robustness and scalability become increasingly important. Beyond scalability, consistent product quality is critical.
In pharmaceutical development, predefined critical quality attributes (CQAs) such as particle size, PDI, encapsulation efficiency and active pharmaceutical ingredient (API) integrity define whether a formulation meets its intended performance and regulatory requirements. These CQAs are established during early formulation development and must be maintained throughout scale-up to ensure product consistency, pharmaceutical efficacy and reproducibility.
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