Understanding Biopharmaceutical Detergents

26 September 2022 10:20 - 10:50

  • The role of detergents in biopharmaceutical formulations
  • Discussing the stability of detergents in biopharmaceutical formulations
  • Exploring formulation effects on detergents
Polysorbates are the workhorse detergents used in biopharmaceutical formulations due to their long established ability to protect therapeutic proteins from interfacial stresses which can other wise lead to protein aggregation. However, research over the last decade has highlighted that polysorbates can undergo oxidative or enzymatically driven degradation with potential knock on impacts to the stability of the biotherapeutic formulation. In this talk key attributes of polysorbates will be reviewed regarding the complexity and consistency of polysorbate structure depending on polysorbate source and quality grade, followed by an exploration into differing impurities present in polysorbates dependant on their quality. Ultimately the effect of these polysorbate qualities will be discussed in the context of storage stability, aqueous solutions along with glass and buffer effects on specific polysorbate species stability, followed by the effect of enzymes on polysorbate derived particulates and the consequences of polysorbate quality on protein aggregation.

Stephen Rumbelow, PhD., Life Sciences Research Fellow, Croda