The biopharmaceutical shift within the drug development industry has focused increasing attention on the behavior of biological molecules in formulation. Aggregation of proteins is key to formulation and stability assessments, with a recent interest in the 100nm - 1µm aggregate size range, identified as an area of concern for immunogenicity and therefore product safety.

The Zetasizer uses Dynamic Light Scattering (DLS) to detect the polydispersity (size spread) of biopharmaceutical formulations. OMNISEC is a high-resolution characterization tool that separates particles present in samples by size and enables the quantification of oligomerization to be measured.

Our NanoSight products, using Nanoparticle Tracking Analysis (NTA) also provide an accurate, reproducible analysis and visualization of particles such as protein aggregates in formulation, in the size range 50nm to 2000nm diameter. Enabling the fluorescence mode in NanoSight instruments allows specific analysis of labeled or intrinsically fluorescent particles.

Measurement of these parameters can provide valuable information on the suitability of a product formulation and may also give an indication of the stability and prospective shelf-life of a product.

Depending on your requirements and/or position on the development pipeline, Malvern Panalytical has an instrument that is able to provide a suitable level of information on issues around protein aggregation, thus ensuring your product achieves the desired stability and efficacy.

Empyrean Nano Edition

Empyrean Nano Edition

Versatile X-ray scattering platform

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Measurement Molecular weight, Particle shape, Particle size, Surface area, Protein aggregation, Protein stability, Phase identification, Phase quantification, Pore size distribution
Goniometer configuration Vertical goniometer, Θ-Θ
Particle size range 1 - 100 nm
Technology X-ray Diffraction (XRD), X-ray Scattering

NanoSight range

NanoSight range

Visually track size and count nanoparticles

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Measurement Particle concentration, Particle size, Protein aggregation
Particle size range 0.01µm - 1µm
Technology Nanoparticle Tracking Analysis
Dispersion type Wet

OMNISEC

OMNISEC

The world’s most advanced multi-detector GPC/SEC system

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Measurement Molecular structure, Molecular size, Molecular weight, Viscosity, Protein aggregation
Molecular weight range 200Da - 10MDa
Minimum sample mass (polystyrene) 100ng
Minimum sample mass (BSA) 100ng
Technology Gel Permeation Chromatography, Size Exclusion Chromatography (SEC), Light Scattering, Static Light Scattering

Zetasizer range

Zetasizer range

The world’s most widely-used systems for nanoparticle, colloid and biomolecular particle sizing and particle charge measurements

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Measurement Molecular size, Molecular weight, Particle size, Zeta potential
Temperature range 0°C - 120°C
Particle size range 0.3nm - 10µm
Technology Light Scattering, Dynamic Light Scattering, Electrophoretic Light Scattering, Static Light Scattering
Dispersion type Wet
Sample cell type Cuvette
Molecular measurement type Chromotography, Batch measurement

Empyrean Nano Edition

Empyrean Nano Edition

Versatile X-ray scattering platform

NanoSight range

NanoSight range

Visually track size and count nanoparticles

OMNISEC

OMNISEC

The world’s most advanced multi-detector GPC/SEC system

Zetasizer range

Zetasizer range

The world’s most widely-used systems for nanoparticle, colloid and biomolecular particle sizing and particle charge measurements

More details More details More details More details
Measurement Molecular weight, Particle shape, Particle size, Surface area, Protein aggregation, Protein stability, Phase identification, Phase quantification, Pore size distribution Particle concentration, Particle size, Protein aggregation Molecular structure, Molecular size, Molecular weight, Viscosity, Protein aggregation Molecular size, Molecular weight, Particle size, Zeta potential
Goniometer configuration Vertical goniometer, Θ-Θ      
Particle size range 1 - 100 nm 0.01µm - 1µm   0.3nm - 10µm
Molecular weight range     200Da - 10MDa  
Minimum sample mass (polystyrene)     100ng  
Minimum sample mass (BSA)     100ng  
Temperature range       0°C - 120°C
Technology X-ray Diffraction (XRD), X-ray Scattering Nanoparticle Tracking Analysis Gel Permeation Chromatography, Size Exclusion Chromatography (SEC), Light Scattering, Static Light Scattering Light Scattering, Dynamic Light Scattering, Electrophoretic Light Scattering, Static Light Scattering
Dispersion type   Wet   Wet
Sample cell type       Cuvette
Molecular measurement type       Chromotography, Batch measurement