Accelerate Your mRNA Therapeutic Development With Precise, High-Resolution Analytical Solutions
Messenger RNA (mRNA) therapeutics and vaccines require rigorous, science-driven analytical characterization to ensure identity, purity, potency, integrity, safety, and long-term stability across research, preclinical and commercial manufacturing stages. Our comprehensive mRNA characterization and analytical development platform combines industry-leading technologies, including LC-MS, HPLC/UPLC, CE, NGS, qPCR/ddPCR, and advanced LNP analytics, with deep expertise in CMC and method development. We support biotechnology companies, pharmaceutical manufacturers, and RNA-based therapeutic developers with high-precision data, validated methods, and IND-ready analytical packages, empowering partners to accelerate development timelines, mitigate risks, and confidently advance high-quality mRNA candidates into commercial success.
mRNA Characterization MethodAccurate and comprehensive mRNA characterization is essential for developing safe, effective, and regulatory-ready mRNA therapeutics. High-quality analytical data ensures product consistency, de-risks CMC development, and supports smooth progression from research through preclinical and commercial manufacturing.
Identity Verification: Confirms the correct mRNA sequence, structure, 5' cap, and poly(A) tail to ensure proper biological function.
Purity & Impurity Profiling: Detects dsRNA, template DNA, enzymes, solvents, and other critical impurities that impact safety and immunogenicity.
Potency Evaluation: Measures translation efficiency and protein expression to validate therapeutic activity.
Stability Assessment: Determines how mRNA degrades under stress or storage conditions to define shelf life and formulation requirements.
Batch-to-Batch Consistency: Ensures manufacturing reproducibility and robustness across scales and production sites.
LNP-mRNA Quality Control: Evaluates encapsulation efficiency, particle size, and integrity for lipid nanoparticle-formulated mRNA products.
Our mRNA characterization platform delivers high-resolution, regulatory-aligned analytical testing designed to support every stage of mRNA therapeutic development—from early discovery to commercial manufacturing. We combine advanced analytical technologies with deep CMC and regulatory expertise to generate precise, actionable data for biotech and pharmaceutical partners.
We ensure that your mRNA molecule is structurally accurate and functionally competent.
Capabilities include:
Business value: Ensures therapeutic effectiveness, reduces early development risks, and supports CMC documentation.
We identify and quantify impurities that impact mRNA safety, immunogenicity, and regulatory compliance.
Capabilities include:
Business value: Establishes impurity control strategies required by FDA/EMA guidelines and strengthens submission packages.
| Impurity Type | Source / Cause | Detection Method | Technologies / Instruments | Typical Acceptance Criteria |
| Double-stranded RNA (dsRNA) | IVT reaction by-products | dsRNA-specific dot blot / ELISA | Anti-dsRNA antibody assay, ELISA reader | As low as technically feasible |
| Residual DNA (Template DNA) | Plasmid template carryover | qPCR / ddPCR | qPCR cycler, ddPCR system | Typically < 10 ng per dose |
| Enzyme Residuals (T7 polymerase, DNase, RNase) | IVT or purification impurities | ELISA | Enzyme-specific ELISA kits | Below assay detection limit |
| Nucleotide & Capping Reagent Residues | Incomplete purification | HPLC / UPLC | HPLC-UV, UPLC-MS | Based on process-specific limits |
| Solvent Impurities (Ethanol, buffers) | Chromatography or LNP prep | GC-MS | Gas Chromatography–MS | Regulatory guideline–aligned |
| Truncated / Fragmented RNA | Degradation or abortive transcription | Bioanalyzer / Fragment Analyzer | CE, Bioanalyzer | Intact RNA ≥ defined threshold |
| Uncapped / Partially Capped RNA | Incomplete capping reaction | LC-MS / HPLC | LC-MS/MS, RP-HPLC | Capping efficiency ≥ 90–95% |
| Protein Impurities | Residual proteins from enzymes | CE-SDS / ELISA | CE-SDS, microplate reader | Below assay detection limit |
| Lipid Residuals (LNP products) | Unencapsulated lipids or excess excipients | HPLC / TLC | HPLC-UV, Thin Layer Chromatography | Process-specific limits |
| Particle Impurities / Aggregates | LNP aggregation or RNA aggregation | DLS / TEM | DLS system, Cryo-TEM | Size & PDI within target window |
We measure the functional performance and therapeutic potential of your mRNA.
Capabilities include:
Business value: Delivers data needed for dose justification, potency assays, and release testing.
We evaluate mRNA behavior under a range of environmental and stress conditions.
Capabilities include:
Business value: Supports formulation optimization, storage strategy, and stability-indicating method development.
For mRNA delivered via lipid nanoparticles, we provide full analytical support.
Capabilities include:
Business value: Essential for vaccine and therapeutic developers using LNP delivery systems, ensuring robust formulation performance.
We develop, refine, and validate analytical methods aligned with regulatory expectations.
Capabilities include:
Business value: Critical for progressing into IND/IMPD submissions and GMP manufacturing.
| Capability Area | Key Tests / Assays | Technologies / Instruments | Typical Outputs |
| Structural & Chemical Identity Analysis |
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| Purity & Impurity Profiling |
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| mRNA Quantification & Potency |
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| Stability Testing & Degradation Analysis |
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| LNP-mRNA Characterization |
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High-quality mRNA characterization relies on advanced, high-resolution analytical instrumentation capable of detecting subtle structural variations, impurities, degradation pathways, and functional performance differences. Our platform integrates a broad suite of industry-standard technologies—including mass spectrometry, chromatography, electrophoresis, sequencing, PCR-based quantification, and nanoparticle characterization systems—to generate accurate, reproducible, and deeply informative data. This robust analytical infrastructure ensures that every mRNA sample is evaluated with the sensitivity, precision, and scientific rigor required for modern RNA therapeutics and delivery systems.
| Platform Category | Instrument / Technology | Applications | Key Features |
| Mass Spectrometry | LC-MS/MS, Q-TOF MS | Identity, capping analysis, modified nucleotide detection | High sensitivity, structural elucidation |
| Chromatography | HPLC (RP, IEX), UPLC | Purity, nucleotides, solvent residues | High resolution separation |
| Electrophoresis | Bioanalyzer, Fragment Analyzer, CE | Integrity, size distribution, truncated RNA | Fast, high accuracy of RNA sizing |
| PCR Platforms | qPCR, ddPCR | Residual DNA, quantification | Ultra-sensitive quantification |
| Sequencing | NGS, Sanger Sequencing | Sequence verification | High-accuracy base calling |
| Immunoassays | ELISA, Western blot | dsRNA, protein/enzyme impurities | High specificity detection |
| Spectroscopy | UV-Vis, Fluorescence (RiboGreen) | RNA quantification | Routine QC measurement |
| LNP Characterization | DLS, Cryo-TEM, NanoSight | Particle size, PDI, morphology | Critical for LNP-mRNA quality |
| Gas Chromatography | GC-MS | Residual solvents | Sensitive to volatile impurities |
| Cell-Based Assays | Flow cytometry, plate reader | Potency, protein expression | Functional potency verification |
| Thermal & Stress Platforms | Stability chambers | Stability, degradation pathways | Compliant stability conditions |
Our mRNA characterization workflow is designed for clarity, regulatory compliance, and seamless collaboration across R&D and preclinical development. Each step is transparent, auditable, and aligned with industry expectations for CMC and analytical development.
We begin with a detailed scientific consultation to understand your project goals, development stage, and regulatory requirements.
Scope includes:
Deliverable: Customized technical proposal & quotation.
Our analytical team designs or transfers assays based on your molecule's characteristics.
Activities include:
Deliverable: Validated or qualified analytical methods ready for sample testing.
Upon sample arrival, we perform:
Deliverable: Sample verification report prior to analytics.
This is the core phase of characterization.
Testing may include:
Deliverable: Raw data, chromatograms, gel images, and preliminary results.
Our senior scientists perform in-depth data review to ensure accuracy and regulatory compliance.
Analysis includes:
Deliverable: Scientific summary highlighting key analytical findings.
We provide continued support throughout your development pipeline.
Services include:
Deliverable: Continuous partnership ensuring long-term project success.
Our mRNA characterization platform is purpose-built for biotechnology and pharmaceutical innovators who need fast, accurate, and high-resolution analytical insights. We combine scientific depth, advanced instrumentation, and a customer-centric service model to accelerate your mRNA development with confidence.
Our mRNA characterization platform supports every stage of therapeutic development—from early discovery to commercial manufacturing. Each application area is backed by specialized analytical capabilities and regulatory-aligned methodologies.
High-quality mRNA characterization is the foundation of safe, potent, and regulatory-ready mRNA therapeutics. Whether you are developing a vaccine, protein-replacement therapy, saRNA platform, or next-generation LNP formulation, our analytical scientists provide the accuracy, depth, and regulatory alignment required for confident decision-making at every development stage.
Partner With a Scientific Team That Understands Your Molecule.
