Rapid Identity and Quantity CQA Test for Multivalent mRNA Drug Product Formulations.

ABSTRACT: The COVID-19 pandemic highlighted mRNA as a promising platform for vaccines and therapeutics. Many of the analytical tools used to characterize the critical quality attributes of mRNA are inherently singleplex and are not necessarily optimal from a labor and cost perspective. Here, we demonstrate the feasibility of a multiplexed platform (VaxArray) for efficient identity verification and concentration determination for both monovalent and multivalent mRNA formulations. A model system comprising mRNA constructs for influenza hemagglutinin and neuraminidase was used to characterize the analytical performance metrics for a VaxArray mRNA assay. The assay presented herein had a time to result of less than 2 h, required no PCR-based amplification nor extraction of mRNA from lipid nanoparticles,

SUBMITTER: Gao RY 

PROVIDER: S-EPMC9612012 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature