Polysorbates for Biopharmaceuticals: An Unnecessarily Complex Mixture or Synergistic Blend?

3/10/2020 10:55 - 11:30

  • Elucidating the complexity of polysorbates
  • Reviewing and clarifying the key differences polysorbates grades
  • Deconvoluting the polysorbate components to understand their role in formulation
  • What makes a polysorbate reduce aggregation in model biopharmaceutical formulations


Abstract

Polysorbates are the work horse of biopharmaceutical formulations, becoming so through a combination of excellent performance in preventing protein aggregation across a huge range of biopharmaceutical actives and a history of safe use stretching back to a period prior to thorough regulation of the pharmaceutical industry. However, as some of the issues with polysorbates have been further elucidated in formulations a greater focus on the chemistry of polysorbates has ensued showing that these materials are remarkably complex mixtures of materials with each component potentially offering positive or negative properties to the formulation.

In this talk the complex nature of polysorbates will be discussed and resolved to show the complexity of the mixture along with how the various grades of commercially available polysorbate differ in structure. Then the discussion will move onto how the various grades and indeed specific components of polysorbates change in their surface chemistry properties and how these affect model biopharmaceutical formulations in terms of their potential to self-aggregate or interact with surfaces to aggregate. In addition, the inherent stability of the polysorbates and their components in their aqueous formulation environment along with the other excipients, actives and their by-products will be discussed.

James Humphrey, Applications Specialist, Croda