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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
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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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Subvisible particle characterization by resonant mass measurement during biopharmaceutical development Webinar - Live (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 analy...

Product:
Archimedes
Date:
September 16 2014
Language:
English

Keywords: English Webinar - Live Greenwich Time Resonant mass measurement Protein aggregation Biopharmaceutical development Biological drug characterization and development Bioformulation development Archimedes 

A new approach to improving early characterization of therapeutic formulations - Viscosizer 200 Webinar - Recorded (English)

The accurate size measurement of both large and small therapeutic molecules within formulations has long been considered a challenge, complicated by the presence of excipient molecules and high background "noise". Malvern's Viscosizer 200...

Product:
Viscosizer 200
Date recorded:
July 2 2014
Language:
English

Keywords: English Webinar - Recorded Eastern Time Protein aggregation Biopharmaceutical development Biological drug characterization and development Bioformulation development Viscosizer 200 

Differentiation and characterization of subvisible particulates in therapeutic protein products Application Note (English)

This application note provides an example of how Archimedes can be used to detect and quantify the formation of protein sub-visible particles and the introduction of silicone oil droplets, in response to shear stress.


Keywords: Contaminants and foreign particles English Application Note Particle concentration Particle size Viruses and vaccines Resonant mass measurement Protein aggregation Proteins Biopharmaceutical development Archimedes 

Protein aggregation - Bridging the sub micron gap Webinar - Recorded (English)

The formation of protein aggregates is a particular concern for parenteral administration biopharmaceuticals due to increased immunogenicity. As a consequence, there is an expectation from regulatory agencies for companies to monitor levels o...

Product:
Archimedes
Date recorded:
June 26 2014
Language:
English

Keywords: English Webinar - Recorded GMT Time Protein aggregation Biopharmaceutical development Archimedes 

PEGylated proteins: Optimizing conjugation reactions using triple detection SEC Application Note (English)

In this application note, interferon α-5 was conjugated with two different PEG molecules in different reactions. The individual protein and PEG molecules, as well as the PEGylated conjugates are characterized by SEC and their composition, mol...


Keywords: English Application Note Molecular size Molecular weight Static Light Scattering Size Exclusion Chromatography Protein aggregation Proteins Biological drug characterization and development Viscotek TDAmax Viscotek SEC-MALS Viscotek UV-PDA Detector (2600) 
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