Steven Alexander Watt
A&M STABTEST, Germany
Title: Quantiï¬ cation of polysorbats: characterization, quantiï¬ cation in ï¬ nal formulation and monitoring of their degradation throughout product shelf-life
Biography
Biography: Steven Alexander Watt
Abstract
Polysorbates (PS), namely PS 20 and PS 80, are widely used in formulations of therapeutic proteins to stabilize and protect these against adsorption, aggregation and precipitation induced by high protein concentration, interfacial or mechanical stress. However, recently there have been increasing reports of issues with PS containing biopharmaceutical drug products, these include clouding phenomena, particulate formation and protein oxidation. In all these cases, there is evidence that PSs or rather their degradation products may be the root cause. The analysis of PSs, due to their heterogeneity, is challenging and although there are robust methods available to quantify PS even in presence of proteins, more comprehensive approaches are required to characterize PS raw materials or monitor their stability throughout the product’s shelf-life. A deeper understanding of impurities and degradants present in PS raw materials and their degradation products arising during storage are essential to understand quality issues and to deï¬ ne control strategies on raw-material level or improve PS stability in the formulation. Here, we propose an LC-MS approach for characterization of PS raw material and a quantitative screening method for fatty acid degradation products in the ï¬ nal formulation. Furthermore, we want to give an outlook on ongoing investigations regarding the impact of packaging material components on PS stability.