Polysorbate 80 (PS-80) has been widely used in formulation of therapeutic proteins as a solubilizer and stabilizer to protect protein against aggregation and adsorption. Isolated cation exchange fractions of a monoclonal antibody were concentrated and buffer exchanged into formulation containing PS-80 to ensure protein stability before subsequent analysis. We investigated the impact of elevated PS-80 concentration in cation exchange fractions on the potency and the purity of a monoclonal antibody. Our study revealed that high levels of PS-80 had a significant impact on the product quality of the fractions and the performance of the cell-based potency assay. Therefore, when possible, use of formulations containing PS-80 are not recommend during buffer exchange.
Learning Objectives:
Learn isolation and characterization of mAb cation exchange fractions strategy.
Understand PS-80 can be enriched during buffer exchange.
Investigate impact of high levels of PS-80 during downstream analytical/potency characterization.
