The Use of Enhanced Analytical Pipelines for the Characterization of Poly(A) and Poly(A)-LNP Formulation Critical Quality Attributes.

ABSTRACT: The number of nucleic acid therapeutics is set to grow within the pharmaceutical industry sector, deploying nanocarrier-based delivery systems as drug products. Poly(A) is a widely used model sequence used in lipid nanoparticle (LNP) formulations for which there are no reported critical quality attributes (CQAs) such as molecular weight, chain length, and impurity profile. In this study, we analyze Poly(A) from three different vendors to measure any existing differences in their CQAs. Poly(A) from these brands was encapsulated in SM102 LNPs using microfluidics to produce three branded Poly(A)-based LNPs. We utilized an orthogonal analytical pipeline approach for both Poly(A) drug substance and LNP drug product CQA evaluation, which included a combination of dynamic light scattering and flo

SUBMITTER: Davidson CG 

PROVIDER: S-EPMC12673581 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature