cGMP SAXS — Small‑Angle X‑Ray Scattering
Industrial SAXS testing for biopharmaceuticals and drug delivery systems. Established protocols, fast delivery, and confidential handling.
Industrial SAXS Testing
- cGMP-compliant SAXS — for selected validated methods, DANNALAB offers SAXS characterization under cGMP with full quality documentation, a capability rarely available in the industry.
- Tailored analytical models — most standard SAXS analysis relies on idealized geometric assumptions that may not adequately represent real biological systems. DANNALAB adapts and extends scattering models to account for the structural complexity of actual samples, improving the accuracy and relevance of characterization results.
The SAXS methodology available at DANNALAB follows the general concepts developed within the beamline communities, particularly at the European Molecular Biology Laboratory (EMBL). DANNALAB, together with EMBL, contributed to the development of EasySAXS — a commercial software package for SAXS data analysis created by the industrial partner (PANalytical BV).
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
Why companies choose DANNALAB for SAXS: We operate as an industrial testing laboratory, not an academic beamline or university facility. This means committed timelines, confidential operations, and business-focused service.
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 −10°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 Applications
Biopharmaceuticals
Drug Delivery
Nanoparticles
Request SAXS Testing Services
Contact us to discuss your SAXS testing needs. Industrial service with established procedures, fast turnaround, and confidential operations.