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Analytical Performance of a Multiplexed Microarray Assay for Rapid Identification and Quantification of a Multivalent
Megan N Gerold1, Evan Toth1, Rebecca H Blair1
1InDevR Inc., 6035 Longbow Dr, Suite 102, Boulder, CO 80301, USA.
Vaccines
|October 26, 2024
Summary
A new VaxArray assay rapidly analyzes multivalent mRNA vaccines, measuring both naked and encapsulated mRNA identity and quantity. This tool enhances quality control for novel mRNA vaccine formulations.
Area of Science:
- Vaccinology
- Molecular Biology
- Analytical Chemistry
Background:
- Messenger RNA (mRNA) vaccines demonstrated high efficacy during the COVID-19 pandemic, establishing them as a promising platform for cancer and infectious disease therapeutics.
- The development of multivalent mRNA vaccines presents analytical challenges for traditional assays designed for monovalent formulations.
- Characterizing critical quality attributes of mRNA vaccines is essential for ensuring safety and efficacy.
Purpose of the Study:
- To develop and validate a multiplexed analytical tool for the rapid characterization of mono- and multivalent mRNA vaccine formulations.
- To assess the identity, quantity, specificity, sensitivity, precision, and accuracy of the VaxArray assay for mRNA analysis.
- To provide a streamlined method for quality control of both naked and lipid nanoparticle-encapsulated mRNA.
Main Methods:
- Utilized nucleic acid microarray technology on the VaxArray platform for multiplexed mRNA analysis.
- Developed an assay capable of measuring mRNA identity and quantity without prior extraction or RT-PCR.
- Tested the assay using a quadrivalent mixture of mRNA constructs encoding four unique proteins encapsulated in lipid nanoparticles.
Main Results:
- The VaxArray assay accurately identified and quantified individual mRNAs in a quadrivalent mixture within 2 hours.
- Demonstrated high specificity for each mRNA component with a sensitivity below 1 µg/mL.
- Achieved high precision (≤10% RSD) and accuracy (100 ± 9%) in quantifying individual mRNAs within lipid nanoparticle formulations.
Conclusions:
- The VaxArray platform offers a rapid, specific, and accurate method for analyzing complex multivalent mRNA vaccine formulations.
- This tool overcomes limitations of standard assays, facilitating efficient quality control for next-generation mRNA vaccines.
- The assay is suitable for characterizing both naked and encapsulated mRNA, supporting diverse vaccine development pipelines.
