Versatile Platform for Speed and Simplicity in mRNA Potency Testing

The project aims to develop an in vitro potency assay for quadrivalent influenza HA mRNA vaccines, as well as assess InDevR’s existing technology to measure HEK293-expressed protein as a functional potency assay.

Project status

66% Completed

Industry Need

The industry would benefit from versatile platforms that could improve speed and simplicity in mRNA potency testing, regardless of manufacturer.

Solution

InDevR plans to develop an in vitro potency assay for quadrivalent influenza HA mRNA vaccines based on its VaxArray platform. The team will also assess InDevR’s existing VaxArray influenza HA protein quantification technology to measure HEK293-expressed protein as a functional potency assay. These assays address complementary critical mRNA vaccine critical quality attributes (CQAs), which are particularly relevant for multiplexed mRNA vaccines.
VaxArray mRNA assay feasibility has been completed, demonstrating specific and precise influenza HA and NA mRNA construct quantification in naked and lipid nanoparticle-encapsulated samples. This work encompasses initial sequence design and testing through manufacturing over 15 months using the optimized assay conditions from the feasibility studies as a starting point.
Existing VaxArray influenza HA protein quantification assays will also be assessed for the quantification of HEK293-expressed HA, and correlations between mRNA input concentration and the expressed protein will be explored to highlight industry relevance further.

Outcomes and Impacts

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.

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Project Lead

InDevR, Inc.