mRNA-LNP Characterization Services
Structural analysis of lipid nanoparticles for mRNA vaccine and therapeutic development. Understand your LNP organization, encapsulation efficiency, and batch-to-batch consistency.
What We Measure in Your LNPs
Beyond particle size: We analyze the internal structure of your lipid nanoparticles — not just the hydrodynamic diameter you get from DLS.
Lipid Bilayer Structure
- Bilayer thickness and organization
- Lipid phase identification
- Ionizable lipid distribution
- Lamellar vs. non-lamellar phases
Particle Architecture
- Particle size distribution
- Core-shell organization
- PEG-lipid corona dimensions
- Morphology determination
Encapsulation Assessment
- mRNA/siRNA localization
- Payload-lipid interaction
- Internal electron density
- Structural integrity
Supporting mRNA Therapeutic Development
From early formulation screening to batch release — structural characterization at every stage of your LNP development pipeline.
Formulation Development
Compare lipid compositions, ionizable lipid variants, and helper lipid ratios. Understand how formulation changes affect LNP structure.
Process Optimization
Characterize LNPs from different manufacturing parameters. Support scale-up with structural consistency data.
Stability Studies
Monitor structural changes during storage. Detect degradation, aggregation, or phase transitions over time.
Batch Release
Verify structural consistency for lot release. Compare production batches against reference standards.
Comparability Studies
Demonstrate structural equivalence after manufacturing changes. Support regulatory filings with comparability data.
Biosimilar Development
Structural comparison against reference products. Support regulatory submissions with detailed characterization.
Why Our LNP Analysis is Different
Internal Structure, Not Just Size
DLS tells you particle size. We reveal the internal organization — bilayer arrangement, core structure, and payload distribution.
Native Aqueous Conditions
Analyze your LNPs in their formulation buffer without staining, fixing, or drying. See the structure as it exists in your product.
Non-Destructive
X-ray scattering is non-destructive. Samples can be recovered for additional testing if needed.
Complementary to Cryo-TEM
We provide ensemble-averaged structural parameters that complement cryo-TEM imaging. Quantitative data from billions of particles.
Technical basis: Our analysis uses Small-Angle X-ray Scattering (SAXS) — an established technique for characterizing nanoscale structures in solution. Learn more about the methodology →
Structural Parameters We Determine
Size & Shape
- Radius of gyration (Rg)
- Particle size distribution
- Shape determination (spherical, elongated)
- Maximum dimension (Dmax)
Bilayer Characteristics
- Bilayer thickness
- Repeat spacing (multilamellar)
- Lipid area per headgroup
- Phase identification
Internal Organization
- Core electron density
- Shell/corona dimensions
- Lamellar stacking
- Internal structure models
Stability Indicators
- Aggregation detection
- Structural changes over time
- Phase transition monitoring
- Batch consistency verification
CMC & Regulatory Support
Structural characterization data formatted for regulatory submissions.
IND-Enabling Data
Early characterization supporting investigational filings. Establish structural acceptance criteria.
BLA/MAA Support
Comprehensive structural data for marketing applications. Batch release specifications.
Post-Approval Changes
Comparability studies supporting manufacturing changes. Site transfers and scale-up.
Documentation Standards
- cGMP-compliant reports available for specific sample types (not always possible — please inquire)
- 21 CFR Part 11 data integrity
- QA-reviewed certificates
- Method validation packages
Industrial Service Standards
Not academic research: We operate as an extension of your CMC laboratory — with committed timelines, confidentiality, and business terms.
Turnaround
Timelines discussed per project based on sample complexity and current capacity. We aim to meet your project deadlines where possible.
Complete Confidentiality
Your data is never published. NDAs accepted as-is. Strict sample handling protocols.
Since 2001
European laboratory with 20+ years pharmaceutical industry experience. Trusted by major pharma.
Example: Liposomal Drug Product Characterization
See how we characterized a liposomal formulation, determining bilayer structure, drug loading, and particle organization.
Liposome-Based Drug Product
Structural characterization of a liposomal formulation showing bilayer thickness, lamellarity, and drug encapsulation.
Request LNP Characterization Services
Contact us to discuss your mRNA-LNP characterization needs. We'll recommend the appropriate analysis for your development stage.
Quick response: We typically respond to inquiries within one business day.
Sample requirements: Minimum 50 µL at ≥1 mg/mL lipid concentration (typical). We can discuss specific requirements for your samples.