Quantitative Laser Diffraction Method for the Assessment of Subvisible Protein Particles

Aggregated protein particles in the size range of 0.2-20 μm have a strong potential to be immunogenic, and in the case of therapeutic protein products, these aggregates can lead to the patient developing resistance to the therapy. Analysis of the size distribution and quantity of aggregates in these therapeutics natively and in response to mechanical stresses can be useful in determining efficacy and safety as well as informing labelling decisions for storage conditions and shelf life.