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. DANNALAB offers this specialized service with the same quality systems, confidentiality, and business focus that pharmaceutical companies require.

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

Learn more about drug delivery characterization →

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 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

Learn More About SAXS

For educational content about small-angle X-ray scattering methodology, principles, and applications, visit our dedicated educational site:

Visit SAXS.eu — Educational Resource →

SAXS.eu provides comprehensive information about the SAXS method for scientists, researchers, and pharmaceutical professionals.

Request SAXS Testing Services

Contact us to discuss your SAXS testing needs. Industrial service with established procedures, fast turnaround, and confidential operations.

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