This project seeks to help improve LNP-mRNA vaccine stability by developing and characterizing LNP-mRNA drug product reference materials that will mimic current COVID-19 vaccine characteristics, deploying LNP-mRNA reconstituted drug product physiochemical and functional critical quality attribute assays for characterization, formulation and stability assessment of reference materials.
Rensselaer and Carnegie Mellon will take the following steps during this project:
Additionally, the team will develop room temperature stable lyo LNP-mRNA drug product formulations and lyo processes which take into account the characteristics of the mRNA payload.
By demonstrating freeze-drying approaches for mRNA-based vaccines as a function of mRNA length and structure that will produce stable material at higher temperatures, this project can further impact domestic and global vaccine distribution by simplifying the cold-chain and reducing lost/wasted doses.
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