cGMP SAXS — Small‑Angle X‑Ray Scattering
Industrial SAXS testing for biopharmaceuticals and drug delivery systems. Established protocols, fast delivery, and confidential handling — not academic research.
Industrial SAXS Testing — Rarely Available Under cGMP
Unique capability: cGMP-compliant SAXS characterization is rarely available in the industry.
The SAXS methodology available at DANNALAB follows the general concepts developed within the beamline communities, particularly at the European Molecular Biology Laboratory (EMBL). Most of the useful information identified by SAXS is related to the higher‑order structure, oligomeric state, aggregation pathway and conformational space of flexible systems.
Key advantage: SAXS permits the observation of objects that have not been stained or fixed, showing them in their native aqueous environment — in contrast to X‑ray crystallography, which generally requires placing the samples in non‑physiological environments.
Learn more about SAXS methodology: Visit www.saxs.eu — our educational resource dedicated to small-angle X-ray scattering.
SAXS for Biologics & Biosimilars
SAXS (and NMR) are the only laboratory methods capable of probing proteins, peptides and lipid assemblies in native solution environments — without crystallization — making them uniquely suited to study biologics and drug delivery systems.
Structural Parameters
- Radius of gyration (Rg)
- Molecular mass estimation
- Shape determination
- Oligomerization state
Higher‑Order Structure
- Ab-initio envelope reconstruction
- Conformational ensembles
- Domain organization
- Flexibility analysis
Stability Assessment
- Aggregation monitoring
- Stress testing
- Temperature dependence
- Formulation optimization
SAXS for Drug Delivery Systems
For various drug delivery systems such as liposomes, nanoemulsions, solid lipid nanoparticles, and nanostructured lipid carriers, SAXS is a valuable tool to reconstruct the nanoscale structure of the carrier.
Liposomal Formulations
- Bilayer thickness and spacing
- Lipid phase identification
- PEG corona dimensions
- Drug loading characterization
Lipid Nanoparticles (LNPs)
- mRNA-LNP assembly structure
- Particle size distribution
- Lipid organization
- Morphology determination
Nanoparticles
- Size and shape analysis
- Specific surface area
- Agglomeration effects
- Core-shell structures
Industrial Service Standards
Established Protocols
Validated SAXS methods ready for immediate use — not experimental research protocols.
Fast Turnaround
Days, not weeks. Committed delivery dates aligned with your project timeline.
cGMP Available
SAXS under cGMP with 21 CFR Part 11 compliance and QA-approved deliverables — rare in the industry.
Expert Interpretation
Clear reports with pharmaceutical context — not academic publications.
No Publication
Your data stays confidential. We don't publish your proprietary information.
Business Terms
Commercial contracts, NDAs, defined deliverables, invoicing — professional business partnership.
SAXS Capabilities
- Sample concentration: Analysis possible with as little as 0.25 wt% in buffer
- Temperature control: In-situ measurements from 4°C to 90°C
- Solution conditions: Various buffers, pH, ionic strength
- Minimal sample consumption: Small volumes required
- Model fitting: Advanced analysis including multi-component systems
- Data quality: Publication-grade data with full documentation
SAXS Methods — Data Analysis Approaches
Different analysis methods extract specific structural parameters from SAXS patterns:
Guinier Analysis
Determination of radius of gyration (Rg) from the initial slope of the scattering pattern. Provides size information without model assumptions.
P(r) — Distance Distribution
Reconstruction of pair distance distribution function revealing particle shape, maximum dimension (Dmax), and internal structure.
Model Fitting
Simulation and fitting of scattering patterns to structural models (spheres, core-shell, bilayers, etc.). Extracts quantitative parameters.
Ab Initio Reconstruction
Model-free reconstruction of particle envelope shape from scattering data. Reveals tertiary structure of proteins and biologics.
Porod Analysis
Determination of specific surface area and interface characteristics. Used for porous materials and aggregates.
Size Distribution Analysis
Reconstruction of particle size distribution for polydisperse systems. Number- and volume-weighted distributions.
SAXS Applications — Sample Types
Types of pharmaceutical samples characterized by SAXS:
Service Types — How We Support Your Development
SAXS services integrated into biopharmaceutical development:
Method Development
Collaborative development of fit-for-purpose SAXS methods. Model selection, validation, and transfer packages.
Formulation Optimization
SAXS screening of buffer conditions, pH, excipients. Optimization of protein stability and LNP structure.
Stability Studies
Monitoring aggregation, conformational changes, and structural stability over time and under stress conditions.
Quality Control
Routine characterization of biologics and drug delivery systems. Lot-to-lot consistency verification.
Application Notes & Conference Posters
View real-world examples of SAXS studies conducted at DANNALAB:
- Liraglutide (GLP-1 Analogue)
- IgG1 Immunoglobulin
- Insulin
- HIV Fusion Inhibitor
- Alpha-Synuclein Aggregation
- C-Terminal Truncated α-Synuclein Fibrils Structure (Publication)
- α-Synuclein Oligomers and Fibrils Characterization (Publication)
- Liposomal Drug Product
- SDS Micelle Structure
- Particle Size Distribution
- Magnetic Nanoparticles
- BioSAXS for Biopharmaceuticals (Conference Poster - with industrial partner)
- Specific Surface Area Determination by SAXS (Conference Poster - with industrial partner)
Request SAXS Testing Services
Contact us to discuss your SAXS testing needs. Industrial service with established procedures, fast turnaround, and confidential operations.