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, 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.
Our 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 Panalytical 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.