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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 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 500nm 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
Particle size range
Dispersion type
Wet
Technology
Dynamic Light Scattering, Static Light Scattering, Size Exclusion Chromatography, Electrophoretic Light Scattering
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NanoSight range Visualize and measure nanoparticle size 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
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Dilute Solution Viscometry, Size Exclusion Chromatography, Gel Permeation Chromatography, Static Light Scattering
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Exploring the role of SEC-MALS in protein and polymer characterization Webinar - Recorded (English)

Size exclusion chromatography (SEC) is a chromatographic technique for the characterization of proteins and biopharmaceuticals, as well as natural and synthetic polymers. Traditional systems comprised a single concentration detector (Conventional Cal...

Product:
Viscotek SEC-MALS,Viscotek 270max,Viscotek TDAmax,Viscotek RImax
Date recorded:
October 17 2014
Language:
English

Keywords: Polymer solutions English Molecular structure Molecular size Molecular weight Gel Permeation Chromatography Static Light Scattering Size Exclusion Chromatography Food additives Rubbers and elastomers Specialty and novel polymers Membrane proteins Polysaccharides Webinar - Recorded GMT Time Protein aggregation Proteins Bioformulation development Antibodies and derivatives Viscotek 270max Viscotek RImax Viscotek TDAmax Viscotek SEC-MALS 

Powerful protein SEC made simple! Webinar - Recorded (English)

This webinar discusses how Malvern’s protein SEC measurement capabilities within the Viscotek range have developed and improved in the last year. We also introduce the new features that are included in the latest release of OmniSEC, including: Bio...

Product:
Viscotek range,Viscotek RImax,Viscotek DSV,Viscotek 270max,Viscotek TDAmax,Viscotek SEC-MALS
Date recorded:
September 30 2014
Language:
English

Keywords: English Viscotek range Molecular structure Molecular size Molecular weight Gel Permeation Chromatography Static Light Scattering Size Exclusion Chromatography Webinar - Recorded Eastern Time Protein aggregation Proteins Biopharmaceutical development Viscotek 270max Viscotek DSV Viscotek RImax Viscotek TDAmax Viscotek SEC-MALS 

The roles of nanoparticles in therapeutic protein aggregation pathways Webinar - Recorded (English)

Recent work by our guest presenter, Dr. John Carpenter (University of Colorado Anschutz Medical Center), discovered that nanoparticles present in solutions of intravenous immunoglobulin (IVIG) serve as precursors for microparticles during pharmaceuti...

Product:
NanoSight range
Date recorded:
September 25 2014
Language:
English

Keywords: Nanoparticles English Particle concentration Particle size Viruses and vaccines Webinar - Recorded Eastern Time Protein aggregation Proteins Biopharmaceutical development NanoSight range Nanoparticle Tracking Analysis 

Coriolis Pharma: Subvisible particle characterization by resonant mass measurement (Archimedes) during biopharmaceutical development Webinar - Recorded (English)

The characterization of subvisible particles is highly relevant for the development of biopharmaceuticals to ensure quality and safety of a therapy. The expectations by the authorities are increasing, which makes it necessary to include analytical me...

Product:
Archimedes
Date recorded:
September 16 2014
Language:
English

Keywords: Contaminants and foreign particles English Particle concentration Particle size Consumer healthcare Viruses and vaccines Sub-visible particles Webinar - Recorded Greenwich Time Resonant mass measurement Protein aggregation Proteins Biopharmaceutical development Biological drug characterization and development Bioformulation development Archimedes 

Characterization of Whey Protein Isolate (WPI) using multi-detector size-exclusion chromatography Application Note (English)

In this application note, a sample of Whey Protein Isolate (WPI) was characterized using the Viscotek TDAmax. The 4 main components in this mixture were separated and individually characterized to determine molecular weight and size. ...


Keywords: English Application Note Molecular size Molecular weight Size Exclusion Chromatography Dairy products Food additives Protein aggregation Proteins Viscotek TDAmax Viscotek TDA 305 
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