Multi-company Survey on the Use and Characterization of Polysorbates in Biotech Products – First Results

Polysorbates (PS) are the most common surfactants in biopharmaceutical products and used to stabilize proteins against various (interfacial) stresses during the product life-cycle. Commercially available PS are complex mixtures with a large structural heterogeneity and variable composition. Additionally, PS may degrade in the therapeutic protein formulation by oxidation or hydrolysis (chemical or enzymatically driven) forming multiple degradants which even may precipitate out and form subvisible and visible particles. This complexity poses challenges during different stages of product development. Within the European Federation of Pharmaceutical Industries and Associations (EFPIA) a group of 23 experts from 16 pharmaceutical companies started to exchange scientific and technical information on the use and characterization of polysorbate in biopharmaceutical products. They worked out a survey with 137 questions to benchmark the handling, analysis, degradation, control strategies, and regulatory aspects of polysorbate. Preliminary results of this survey will be presented.