mRNA vaccine developers face significant challenges in potency testing for multivalent products. Current methods—such as sequencing and PCR—are time-intensive, complex to validate, and often lack flexibility for codon optimization or variant updates. Manufacturers need rapid, multiplexed assays that can confirm identity, quantify mRNA constructs, and measure functional protein expression in formats compatible with high-throughput workflows. These capabilities reduce development bottlenecks and support global readiness for seasonal and pandemic influenza vaccines.
InDevR developed and commercially launched two complementary VaxArray-based platforms:
The project also implemented in-house transfection and LNP encapsulation capabilities, updated imaging system software for 96-well compatibility, and demonstrated assay performance across 40+ mRNA constructs spanning 11 influenza seasons.
The objective of this project is to make the VaxArray influenza mRNA assay capable of simultaneous quantification of the four HA mRNA constructs in quadrivalent influenza mRNA vaccines, regardless of manufacturer.
Quantification assays will also be assessed, and correlations between mRNA input concentration and the expressed protein will be explored
Development of an in vitro potency assay for quadrivalent influenza HA mRNA vaccines
Assess existing technology to measure HEK293-expressed protein as a functional potency assay
Address complementary critical mRNA vaccine critical quality attributes (CQAs)
Adoption of these platforms could reduce potency testing turnaround from days to <2 hours, cut per-assay costs by up to 40%, and increase throughput by 2–3× through compatibility with 96-well workflows. The mRNA fluIQ assay demonstrated specificity across 40+ constructs and linearity over a broad concentration range, while OmniFlu HA 96 enables simultaneous quantification of all expressed proteins in quadrivalent transfections. These capabilities support predictive QC and faster decision-making during development and scale-up.
Commercially launched VaxArray mRNA fluIQ assay for identity and quantity testing
Commercially launched VaxArray OmniFlu HA 96 assay for functional potency readout
Software upgrade: VaxArray Imaging System V3.1 for 96-well compatibility
Infrastructure enhancements: In-house HEK293 transfection and mRNA-LNP encapsulation capabilities
Conference dissemination: 10 presentations/webinars highlighting NIIMBL-funded work
Manuscript in progress: Multiplexed VaxArray DNA Microarray Assay for Rapid Influenza HA mRNA Vaccine Characterization
BRL advancement: From 5 → 7; tools now commercially available and manufactured under ISO 13485 QMS
Dawson, E., From Bottlenecks to Breakthroughs: Advancing mRNA Vaccine Development with Same-Day Analytics, 3rd Annual mRNA Analytical Development Summit, Boston, MA, February 14, 2024.
Dawson, E., Next Generation Rapid mRNA Vaccine CQA Analytics, European Pharmaceutical Review Webinar, Virtual, March 6, 2024.
Dawson, E., Rapid Multiplexed Analytics for mRNA Vaccines, ECI Vaccine Technology IX, Cabo San Lucas, Mexico, May 19, 2024.
Dawson, E., Rapid VaxArray Multiplexed Analytics for mRNA Vaccines, NIIMBL National Meeting, Washington, DC, June 25, 2024.
Dawson, E., VaxArray Multiplexed Analytics for mRNA-based Vaccines and Therapeutics, BioProcess International and Cell and Gene Therapy International, Boston, MA, September 24, 2024.
Dawson, E., VaxArray: Same-Day Multiplexed Vaccine Analytics, NIIMBL National Meeting, Washington, DC, June 25, 2024.
Gao, R., From Bottlenecks to Breakthroughs: Advancing mRNA Vaccine Development with Same-Day Analytics, USP Open Forum: Collaborating to Pave the Way for mRNA-Based Vaccines and Therapeutics Quality, Virtual, February 29, 2024.
Johnson, A., mRNA Vaccine Characterization: Multivalent Identity, Integrity, and Quantity Analytics Using VaxArray, 2nd Annual mRNA Quality Control and Compliance, Boston, MA, June 26, 2024.
Lacey, R., High-Throughput, Multiplexed Analysis of HA and NA Content Across All Influenza Vaccine Production Platforms, World Vaccine Congress Europe, Barcelona, Spain, October 29, 2024.
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InDevR, Inc.
