One Platform. Multiple Raw Material Challenges

Biothentix™ provides standardized, multiplexed analytical solutions for raw material identity verification and characterization across the cell and gene therapy supply chain.

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.

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Custom Analytical mRNA Solutions

Confirm identity and measure quantity of multivalent naked or LNP-encapsulated mRNA in < 2 hours with our flexible platform.

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Measure Intact mRNA and 5’ Capping in 1 Assay

Rapidly measure capped and intact mRNA and 5’ capping efficiency at your benchtop. InDevR’s off-the-shelf 5’CapQ Assay measures mRNA intactness with an easy-to-use microarray-based platform.

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Universal Influenza HA mRNA Identity and Quantity

Quantify multivalent influenza HA mRNA quickly regardless of codon optimization schemes. mRNA fluIQ is designed to provide universal reactivity with HA mRNAs.

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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.

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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.

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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 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.

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Raw Material Characterization

Generate analytical fingerprints that establish material identity, evaluate media formulations on cell proliferation during development, detect lot-to-lot variability from a supplier or in-house lab, or compare media from multiple suppliers.

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Cell Culture Media Providers

Differentiate complex media products with encoded Certificates of Analysis that verify identity and consistency while protecting proprietary formulation information.

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iPSC Product Lifecycle

Biothentix provides a standardized platform for quantifying multiple proteins in a single assay, creating a common analytical language across development stages, teams, laboratories, and manufacturing sites.

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CGT Developers & Biopharma

Improve confidence in supplier consistency, strengthen quality systems, and make better-informed development and manufacturing decisions using harmonized raw material identity verification.

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CDMO/Contract Testing Labs

Accelerate onboarding, technology transfer, and incoming material verification using standardized methods that can be shared across suppliers, customers, and testing sites.

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How Biothentix Works

Biothentix reagent kits are designed to measure multiple raw material attributes in a single standardized workflow. The resulting analytical fingerprint can be used to compare incoming lots against a qualified reference, support supplier qualification, monitor lot-to-lot consistency, and generate digital, traceable results for quality documentation.

For proprietary formulations, Biothentix can support an encoded Certificate of Analysis approach. Suppliers can release materials using a defined fingerprint, while customers can verify that an incoming lot matches the expected profile without requiring disclosure of the underlying formulation.

Built on InDevR’s multiplex analytical platform, Biothentix combines standardized reagent kits, automated software analysis, and QC-compatible workflows to help organizations gain earlier and more consistent insight into complex biological raw materials.

Fit-for-Purpose Kits. Standardized Results.

Biothentix kits are designed around the raw material attributes that matter most to your process, then converted into standardized, software-defined workflows for reproducible testing across sites and users.

Complex biological raw materials are rarely one-size-fits-all. Each Biothentix kit is customized around the specific attributes a user needs to monitor, while preserving the consistency, documentation, and ease of use expected from a standardized assay workflow. Users can define the cytokines, growth factors, enzymes, or other proteins most relevant to their material, process, or quality-control strategy, and InDevR applies its proven reagent kit build process to create a fit-for-purpose multiplex kit. Typical kit build times are less than six weeks, with performance optimization and verification available as add-on services.

Once built, the customized kit can be run using the ArrayView™ platform and a standardized workflow with data automatically analyzed and interpreted by InDevR’s 21 CFR Part 11-ready software. The result is a tailored analytical fingerprint that can be implemented reproducibly across development, supplier qualification, incoming inspection, and routine raw material verification.

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