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Synthesis, characterisation and degradation of polysorbates in biopharmaceuticals

Polysorbates in biologics delivery

Polysorbates are essential in biologics delivery, serving as crucial emulsifiers and stabilisers for biopharmaceuticals. They enhance solubility, improve bioavailability, and protect proteins from denaturation and aggregation, extending product shelf life and ensuring the safety and efficacy of these vital medications. 

However, impurities found in polysorbates, and other excipients, can have a negative effect on the overall formulation. In protein formulations, for example, free fatty acids are known to cause particle formation, while peroxide and aldehyde impurities can oxidise the functional residues such as methionine and tryptophan, ultimately leading to the degradation of the protein API.  

Surfactants in Biopharmaceutical Development addresses the progress, challenges, and opportunities in surfactant research, within biologic therapeutics. This comprehensive book explores the importance of high purity polysorbates, their synthesis, characterisation, and degradation. The synthesis methods and purity levels of polysorbates are examined in-depth, highlighting their significant impact on the stability of monoclonal antibody (mAb) formulations and active pharmaceutical ingredients (APIs). 

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Discover more about our high purity polysorbates

Croda offers a range of high-purity polysorbate products, widely used in currently marketed protein-based therapeutics for their low impurity profile and effectiveness in stabilising complex formulations.