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Related Experiment Video

Updated: Aug 23, 2025

Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays

Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays

Published on: November 10, 2016

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

Rachel Y Gao¹, Christine M Riley¹, Evan Toth¹

¹InDevR Inc., 2100 Central Ave., Suite 106, Boulder, CO 80301, USA.

|October 27, 2022

Summary

A new multiplexed platform (VaxArray) offers efficient mRNA analysis, verifying identity and concentration for vaccines. This rapid assay requires no amplification or extraction, proving valuable for mRNA vaccine development.

Keywords:

CQA VaxArray influenza lipid nanoparticle mRNA vaccine multiplexed nucleic acid microarray

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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

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Published on: April 23, 2019

Area of Science:

Biotechnology
Molecular Biology
Vaccinology

Background:

Messenger RNA (mRNA) has emerged as a critical platform for vaccines and therapeutics, particularly highlighted by the COVID-19 pandemic.
Current analytical methods for characterizing mRNA critical quality attributes are often singleplex, leading to inefficiencies in labor and cost.
There is a need for optimized, high-throughput analytical techniques for mRNA characterization.

Purpose of the Study:

To demonstrate the feasibility of a multiplexed analytical platform, VaxArray, for mRNA analysis.
To evaluate the VaxArray platform for efficient identity verification and concentration determination of mRNA formulations.
To assess the analytical performance of a VaxArray mRNA assay using a model system.

Main Methods:

Development and validation of a multiplexed VaxArray assay for mRNA analysis.
Utilized a model system with mRNA constructs encoding influenza hemagglutinin and neuraminidase.
Characterized analytical performance metrics including specificity, sensitivity, accuracy, and precision.
Assayed both monovalent and bivalent mRNA formulations without prior mRNA extraction or PCR amplification.

Main Results:

The VaxArray assay provided results in under 2 hours.
The assay demonstrated high construct specificity, suitable for analyzing bivalent mRNA mixtures.
Achieved vaccine-relevant sensitivity (sub-µg/mL) for influenza mRNA targets.
Reported average accuracy of 104 ± 2% and precision of 9 ± 2%.

Conclusions:

The VaxArray platform offers a rapid, efficient, and specific method for analyzing mRNA identity and concentration.
This multiplexed approach overcomes limitations of singleplex assays, reducing labor and cost.
The VaxArray assay is suitable for characterizing mRNA vaccine candidates, including multivalent formulations.