Rapid Multiplexed Solutions for mRNA Applications
Eliminate mRNA analytical development bottlenecks and accelerate your path to market with custom multiplex mRNA solutions.
InDevR is your trusted partner for multiplexed assay development and integration during production and release of high-valency mRNA drug products, confirmation of protein expression, and serological testing in clinical and pre-clinical trials.
mRNA Assay Capabilities
Custom Analytical mRNA Solutions
Characterize multivalent naked mRNA or LNP-encapsulated mRNA vaccines without additional cumbersome steps. Our flexible platform assesses vaccine quality in <2 hours, including identity, quantity, integrity, 5’ capping efficiency and 3’ polyA tail efficiency.
Universal Influenza HA mRNA Identity and Quantity
Quantify your multivalent influenza HA mRNA vaccine with an assay designed for broad reactivity with HA mRNA sequences. Reduce influenza mRNA analytical development time by implementing this unprecedented solution in your facility.
Multiplexed Influenza Protein Quantification
InDevR offers off-the-shelf VaxArray Assays that target hemagglutinin (HA), neuraminidase (NA) and nucleoprotein (NP) for multiplexed protein quantification from mRNA-transfected cell culture.
Custom Protein Quantification Assay forCustomer-specific Antigens
If one of our off-the-shelf-kits doesn’t meet your needs, our Expert Services Team can design a custom assay for you. An immunoassay specific to the target antigen can be developed for rapid and accurate quantification post-transfection.
Analyze Serum Samples Against Your Antigens
Accelerate pre-clinical and clinical trial testing by having our Expert Services team develop an assay to rapidly quantify the antibody response to the specific antigens in your serological samples. VaxArray multiplexing capabilities enable evaluation of immunogenicity for all antigen targets in your multivalent mRNA drug product in a single test, increasing sample throughput and analysis during drug development.
Simplify mRNA Analytics
mRNA integrity and identity mean different things to different people. Work with InDevR’s Expert Services Team to design custom-tailored solutions for your mRNA sequences utilizing the flexibility of the VaxArray Platform. Custom assays can be developed for quantity, identity, integrity, 5’ capping efficiency, and 3’-polyA tailing efficiency, and are compatible with pre- and post-LNP encapsulated samples without additional processing steps.
Case Studies for Custom mRNA Characterization
A customer sought quantity and identity of a mixture of bivalent mRNAs with 87% sequence identity to serve as a Critical Quality Attribute (CQA) method for vaccine release. A custom multiplex mRNA quantification assay was developed, where specific and accurate quantification was achieved for the bivalent mixture of LNP-encapsulated mRNA.
Current vaccine companies use complex chromatographic methods that can take 1-2 days with additional queue and analysis time to measure 5’ capping efficiency. The VaxArray 5′ capping assessment was flexibly configured to quantitate mRNA 5’ capping efficiency in under 2 hours. mRNA samples that differed by 5% capping ratios were statistically differentiated within 1.5% of expected.
Universal Influenza HA mRNA Identity and Quantity
This VaxArray Assay contains multiple capture oligos specific for influenza A/H1, A/H3, B/Yamagata, and B/Victoria hemagglutinin (HA) vaccine components, and has been strategically designed for different codon optimization schemes to provide universal reactivity with HA mRNAs.
- Reactive to naked and LNP-encapsulated mRNA without a separate extraction step.
- Compatible with strains over 11 vaccine seasons with different codon optimization schemes and UTRs.
InDevR’s Expert Services team can perform sample testing with your specific mRNA constructs. Contact us to send your influenza HA mRNA constructs for testing.
Each mRNA construct was quantified using a standard curve with good linearity over low µg/mL mRNA concentration range.
Simultaneous Multivalent Protein Characterization
InDevR offers off-the-shelf VaxArray Assays for influenza HA, NA, and NP characterization after mRNA transfection in cell culture.
- Assess multivalent expressed proteins with high specificity for mRNA construct development, manufacturing, and product release.
- Subtype-specific HA and NA assays enable simultaneous quantification of multivalent mRNA formulations. Reactivity is re-evaluated semi-annually with updated vaccine strains.
- Stability-indicating immunoassay measures biologically-relevant forms of expressed HA and NA.
Evaluate functional protein during optimization of transfection conditions. Contact us for more information on our ready to go kits.
There is a need to measure intact, expressed HA and NA from cells that are transfected with influenza mRNA vaccines. HEK293-expressed protein post-transfection with a quadrivalent mixture of influenza HA mRNA constructs was measured by the OmniFlu HA Assay as a function of input mRNA concentration. Protein expression correlated with mRNA concentration, and, as expected, the different proteins exhibited different expression levels.
Publications
Gao R.Y., et al. Rapid identity and quantity CQA test for multivalent mRNA drug product formulations. 2022. Vaccines. 10(10): 1704. doi: 10.3390/ vaccines10101704
