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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
Measurement
Particle size, Protein aggregation, Particle concentration
Particle size range
0.05µm to 5µm
Technology
Resonant mass measurement
More information
Zetasizer range The worlds most widely used system for nanoparticle, colloid and protein size, zeta potential and molecular weight measurements. Image
Measurement
Molecular size, Particle size, Molecular weight, Zeta potential
Temperature range
90°C
Particle size range
0.3nm to 10µm
Dispersion type
Wet
Technology
Dynamic Light Scattering, Static Light Scattering, Size Exclusion Chromatography, Electrophoretic Light Scattering
More information
NanoSight range Characterizing Nanoparticles: Visualizing, Sizing and Concentration Image
Measurement
Particle size, Particle concentration, Protein aggregation
Particle size range
10nm to 2000nm
Technology
Nanoparticle Tracking Analysis
More information
Viscotek range The leading multi-detector GPC/SEC systems and detectors. Image
Measurement
Molecular structure, Molecular weight, Molecular size, Protein aggregation, Rheology and viscosity
Temperature range
25°C to 160°C
Technology
Dilute Solution Viscometry, Size Exclusion Chromatography, Gel Permeation Chromatography, Static Light Scattering
More information
 
 

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Compositional insights for protein mixtures: a case study of a semi-pure β-amylase extract Application Note (English)

In this application note, we describe the analysis of a semi-purified protein mixture containing β-amylase.  Step-by-step, we show how different properties of the proteins elicit a specific response in each detector and how the coupling this data can...


Keywords: English Application Note Molecular structure Molecular size Molecular weight Gel Permeation Chromatography Static Light Scattering Size Exclusion Chromatography Protein aggregation Proteins Biopharmaceutical development OMNISEC 

Unsurpassed protein SEC using the latest innovation in advanced detection, OMNISEC Webinar - Recorded (English)

During this webinar, we introduces the latest innovations in SEC technology, and discuss how the new OMNISEC system will assist your protein characterization challenges. Focusing on applications, the webinar compares the capabilities of the system wi...

Product:
OMNISEC
Date recorded:
April 22 2015
Language:
English

Keywords: English Molecular weight Gel Permeation Chromatography Size Exclusion Chromatography Webinar - Recorded Eastern Time Protein aggregation Proteins Protein mobility OMNISEC Protein stability 

Characterize subvisible protein particles in formulations Webinar - Recorded (English)

Guest presenter - Prof. Dr. John Carpenter, University of Colorado Counting and sizing of subvisible particles in therapeutic protein formulations are critically important activities for product development and quality assurance. Such characterizati...

Product:
Archimedes
Date recorded:
March 25 2015
Language:
English

Keywords: English Webinar - Recorded Eastern Time Resonant mass measurement Protein aggregation Biopharmaceutical development Archimedes 

The Benefits of Multi-Detector SEC for Protein Analysis Article (English)

Using a light scattering detector as part of a multi-detector Size Exclusion Chromatography system provides the accurate molecular weight (MW) data needed to assess the activity, safety and clinical efficacy of therapeutic proteins.


Keywords: English Article Molecular structure Molecular size Molecular weight Gel Permeation Chromatography Static Light Scattering Size Exclusion Chromatography Protein aggregation Proteins Biopharmaceutical development Viscotek TDAmax Viscotek TDA 305 

Challenges in the measurement of protein zeta potential Poster (English)

Research shows that aggregation of a protein sample that occurs during electrophoretic measurements is more likely to take place at the electrodes. A new measurement method, the Diffusion Barrier Technique, described in this poster protects the prote...


Keywords: English Poster Particle size Dynamic Light Scattering Electrophoretic Light Scattering Zetasizer Nano ZS Protein aggregation Proteins Zetasizer Nano ZSP Protein mobility Biopharmaceutical development 
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