Expanding the toolbox of surfactants available for biologics formulations with Kolliphor® HS 15 and Kolliphor® ELP

The purpose of this study was to evaluate the performance of the surfactants Polyoxyl 15 Hydroxystearate (Kolliphor® HS 15) and Polyoxyl-35-castor oil (Kolliphor® ELP) in stabilizing proteins formulations. Surfactants are an essential component of biologics formulations, as they stabilize protein therapeutics such as monoclonal antibodies and fusion proteins against destabilizing interfacial and hydrophobic interactions.

The current toolbox of surfactants used in approved biologics formulations is limited to polysorbate 80, polysorbate 20, and poloxamer 188, with polysorbate 80 being the most commonly used surfactant. However, it is well established that polysorbates suffer from degradation issues that can cause safety concerns and damage to the active pharmaceutical ingredients (APIs).

Therefore, there is an unmet need within the biopharmaceutical industry for additional surfactants that can be used to stabilize biologics formulations for parenteral administration.

See the poster here (click to enlarge):

DOWNLOAD THE POSTER AS A PDF