Polysorbate Analysis in Biopharmaceutical Applications—A Snapshot of the Analytical Toolbox

Polysorbates (PS) are added to biopharmaceutical formulations stabilize proteins and monoclonal antibodies (mAbs) prevent aggregation, denaturation, surface adsorption. Polysorbate analysis can be challenging because of their inherent complexity, polydispersity, presence in matrices containing high concentrations other excipients such as sugars, amino acids, salts, buffers. This instalment “Biopharmaceutical Perspectives” provides an overview different approaches for the qualitative quantitative polysorbates, its impurities degradants raw material, intermediate dilutions, drug substance, products. Various gas (GC) liquid chromatography (LC) methods accompanying detection techniques briefly discussed illustrated with results obtained at authors’ laboratory.