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SEC-MALS

Size Exclusion Chromatography – Multi-Angle Light Scattering (SEC-MALS) is a commonly used analytics for biologics in the determination of aggregation/oligomers, drug purity and fragment impurities.  The technique combines the chromatographic separation by molecular size and the determination of absolute molar mass by light scattering without the limitations of MW standard calibration.  The light scattering instrumentation also includes a Quasi- Elastic Light Scattering (QELS) and Refractive Index (RI) detectors for added versatility.  SEC-MALS is typically employed during analytical characterization and early phase clinical trials of antibody and protein based therapeutics to support FDA IND submissions.  More recent application includes analysis of extracellular vesicle (EV) – based therapeutics involving exosomes or microvesicles.

Ideal Uses
  • % Purity analysis of biomolecules
  • Determination of aggregation/oligomers and fragment impurity
  • Absolute measurement of molar mass, hydrodynamic and RMS radius
  • Provides information on biomolecular shape, conformation or structure
Technical Specifications
  • Molar mass measurements from 200 Da to 20 mDa
  • Molecular radius determination from 10 to 150 nm
  • Sensitivity is 1 µg/mL or 0.5 µg of BSA
  • 3 angle static scattering and 90° dynamic light scattering (DLS) optics
Strengths
  • Programmable and modular system
  • Quantitative and Validatable methods
  • Integrated with the standard Empower chromatographic system
Limitations
  • Limitation in the molecular size range
  • Analysis are conducted under ambient temperature only