Polysorbate Analysis in Biopharmaceutical Application: A Snapshot of the Analytical Toolbox

Polysorbates (PS) are added to biopharmaceutical formulations to stabilize proteins and monoclonal antibodies (mAbs) and to prevent aggregation, denaturation, and surface adsorption. Polysorbate analysis can be challenging because of their inherent complexity, polydispersity, and their presence in matrices containing high concentrations of proteins and other excipients such as sugars, amino acids, salts, and buffers.This instalment of 'Biopharmaceutical Perspectives' provides an overview of different approaches for the qualitative and quantitative analysis of polysorbates, its impurities and degradants in raw material, intermediate dilutions, drug substance, and drug products. Various gas (GC) and liquid chromatography (LC) methods and accompanying detection techniques are briefly discussed and illustrated with results obtained at the authors' laboratory.
Polysorbates (PS) are a class of nonionic surfactants mainly used in the food and pharmaceutical industry. In the biopharmaceutical field, polysorbate 20 (PS20) and 80 (PS80) are widely accepted and [...]