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 formulation. Aggregation of proteins is key to formulation and stability assessments, with an emphasis on 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, SEC separates particles present in samples by size and enables 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 - 5µm, 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.
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.