Protein aggregation

Characterization of sub-visible protein aggregates in biotherapeutic formulations

The biopharmaceutical shift within the drug development industry has focused increasing attention on the behavior of biological molecules in formulations. 

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.

Measurement parameters

Measurement of these parameters can provide valuable information on the suitability of a product formulation, and may also indicate the stability and prospective shelf-life of a product:

  • particle size
  • polydispersity (size spread)
  • oligomerization
  • protein aggregates
  • labeled or fluorescent particles

Our instruments

Depending on your requirements and/or position on the development pipeline, Malvern Panalytical has an instrument that can provide a suitable level of information on issues around protein aggregation. 

Our instruments are designed to ensure your product achieves the desired stability and efficacy.

Zetasizer range

Our Zetasizer range uses Dynamic Light Scattering (DLS) to detect the polydispersity (size spread) of biopharmaceutical formulations. 

Find out more about the Zetasizer range >> 

OMNISEC

OMNISEC

OMNISEC

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

OMNISEC is a high-resolution characterization tool that separates particles present in samples by size and enables the quantification of oligomerization to be measured.

Find out more about OMNISEC >>

Nanosight Pro

NanoSight Pro

NanoSight Pro

Characterizing Nano- and Biomaterials has never been so quick, easy, and ac...

Our NanoSight Pro instrument uses Nanoparticle Tracking Analysis (NTA). This provides accurate, reproducible analysis and visualization of particles such as protein aggregates in formulation. It operates in the size range of 50 nm to 2000 nm diameter. 

Enabling the fluorescence mode in NanoSight Pro instrument also allows specific analysis of labeled or intrinsically fluorescent particles.

Find out more about the Nanosight Pro >> 

Zetasizer Advance Range

Zetasizer Advance Range

Light Scattering for every application

OMNISEC

OMNISEC

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

NanoSight range

NanoSight range

Visually track size and count nanoparticles

Technology
Dynamic Light Scattering
Nanoparticle Tracking Analysis
Size Exclusion Chromatography (SEC)