High-throughput, fluorescence-based esterase activity assay for assessing polysorbate degradation risk during biopharmaceutical development

27 September 2022 13:50 - 14:25

  • Hydrolytic degradation of polysorbate during 2–8°C storage of monoclonal antibody drug products has been attributed to residual enzymes
  • A fluorescence, plate-based esterase activity assay was developed as a monitoring and characterization tool for polysorbate degradation
  • High-throughput method allows for rapid characterization of monoclonal antibody samples
  • Esterase assay correlates directly with polysorbate degradation

Adithi Bhargava, Technical Development Scientist, Genentech