Polysorbates play a key role in stabilizing 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. Consequently, there is a lot of ongoing interest in the chemistry of polysorbates, since 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 how differences in purity levels in the various grades of commercially available polysorbate can impact performance. Then the discussion will also cover how the various grades and indeed specific components of polysorbates, can impact formulation stability, including changes in formulation stability and issues around protein self-aggregation.
Stephen Rumbelow, Research and Technology Manager R&D, Innovation Support and Health Care, Croda