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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.

While the Zetasizer uses Dynamic Light Scattering (DLS) to detect the polydispersity (size spread) of biopharmaceutical formulations, Viscotek SEC products are able to separate particles present in samples by size and enable the quantity of oligomerization to be measured.

Archimedes uses the technique of resonant mass measurement to both reliably count the number of particles in the size range 50nm to 5µm (with a lower limit of detection of 200nm diameter for protein particles specifically), and also to provide measurements such as particle mass and size, and information on sample concentration, viscosity, density and volume. Via its measurement of relative buoyant mass, Archimedes is also able to distinguish between positively buoyant particles such as contaminating silicone oil, and negatively buoyant particles such as protein aggregates.

Malvern 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 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.

Related products

Archimedes Particle Metrology System Image
Particle size, Protein aggregation, Particle concentration
Particle size range
0.05µm to 5µm
Resonant mass measurement
More information
Zetasizer range The world's most widely used system for nanoparticle, colloid and protein size, zeta potential and molecular weight measurements. Zetasizer range - particle size, dynamic light scattering, zeta potential, protein aggregation
Molecular size, Particle size, Molecular weight, Zeta potential
Temperature range
Particle size range
0.3nm to 10µm
Dispersion type
Dynamic Light Scattering, Static Light Scattering, Size Exclusion Chromatography, Electrophoretic Light Scattering
More information
NanoSight range Characterizing Nanoparticles: Visualizing, Sizing and Concentration NanoSight range - measurement of exosomes, nanoparticles and protein aggregation
Particle size, Particle concentration, Protein aggregation
Particle size range
10nm to 2000nm
Nanoparticle Tracking Analysis
More information
Viscotek range The leading multi-detector GPC/SEC systems and detectors. Image
Molecular structure, Molecular weight, Molecular size, Protein aggregation, Rheology and viscosity
Molecular weight range
1000Da to 10MDa
Minimum sample mass (polystyrene)
Minimum sample mass (BSA)
Dilute Solution Viscometry, Size Exclusion Chromatography, Gel Permeation Chromatography, Static Light Scattering
More information

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Characterization of protein aggregates in suspension and on a filter membrane by Morphologically-Directed Raman Spectroscopy Application Note (English)

The combination of static microscopy and Raman spectroscopy in the Morphologi G3-ID enables automated chemical identification of protein aggregates and other contaminants in a biotherapeutic sample, either in suspension via a thin path wet cell or on...

New technologies to improve the understanding of bioformulation stability Webinar - Live (English)

Understanding the relationship between formulation stability and protein aggregation is a critical during bio therapeutic development. As a consequence, a number of new technologies, are now available which offer detailed insights into protein behav...

August 4 2015

Medición de Masa Resonante - Archimedes Webinar - Live (Spanish)

Esta es una plática introductoria general acerca del equipo de Archimedes. El objetivo es presentar el equipo, la técnica de medición que utiliza, cómo es que realiza la medición, que tipo de información podemos obtener, hablar sobre los límites de d...

July 31 2015

Keywords: Webinar - Live Mexico Time Resonant mass measurement Protein aggregation Biopharmaceutical development Spanish Archimedes 

Protein stability measurements amplified: Combining SEC-MALS and DLS to maximize data output Application Note (English)

The stability of a protein sample and its tendency to aggregate is explored using a combination of SEC-MALS and DLS

Ten reasons protein characterization scientists should upgrade from single to multi-detector SEC Whitepaper (English)

The top 10 reasons to consider an advanced multi-detector SEC system, which incorporates light scattering detectors for the measurement of absolute molecular weight and molecular weight distribution with excellent accuracy.

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Medición de Masa Resonante - Archimedes
(July 31 2015)

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