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Quantification of mRNA in Lipid Nanoparticles Using Mass Spectrometry.
Lowenthal, Mark S; Antonishek, Abigail S; Phinney, Karen W.
Affiliation
  • Lowenthal MS; Biomolecular Measurement Division, Material Measurement Lab, National Institute of Standards and Technology (NIST), Gaithersburg, Maryland 20899, United States.
  • Antonishek AS; Biomolecular Measurement Division, Material Measurement Lab, National Institute of Standards and Technology (NIST), Gaithersburg, Maryland 20899, United States.
  • Phinney KW; Biomolecular Measurement Division, Material Measurement Lab, National Institute of Standards and Technology (NIST), Gaithersburg, Maryland 20899, United States.
Anal Chem ; 96(3): 1214-1222, 2024 01 23.
Article in En | MEDLINE | ID: mdl-38189247
ABSTRACT
Lipid nanoparticle-encapsulated mRNA (LNP-mRNA) holds great promise as a novel modality for treating a broad range of diseases. The ability to quantify mRNA accurately in therapeutic products helps to ensure consistency and safety. Here, we consider a central aspect of accuracy, measurement traceability, which establishes trueness in quantity. In this study, LNP-mRNA is measured in situ using a novel liquid chromatography-mass spectrometry (LC-MS) approach with traceable quantification. Previous works established that oligonucleotide quantification is possible through the accounting of an oligomer's fundamental nucleobases, with traceability established through common nucleobase calibrators. This sample preparation does not require mRNA extraction, detergents, or enzymes and can be achieved through direct acid hydrolysis of an LNP-mRNA product prior to an isotope dilution strategy. This results in an accurate quantitative analysis of mRNA, independent of time or place. Acid hydrolysis LC-MS is demonstrated to be amenable to measuring mRNA as both an active substance or a formulated mRNA drug product.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Nanoparticles / Isotopes / Liposomes Language: En Journal: Anal Chem Year: 2024 Document type: Article Affiliation country: United States Country of publication: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Nanoparticles / Isotopes / Liposomes Language: En Journal: Anal Chem Year: 2024 Document type: Article Affiliation country: United States Country of publication: United States