AdvanceBio Surfactant Profiling HPLC Columns

Polysorbates consist of three major components: a hydrophilic headgroup such as sorbitan, four chains of polyoxyethylene moieties, and a fatty acid at the end of each chain. One of the mechanisms by which polysorbates degrade is hydrolysis. Hydrolysis cleaves the ester bonds and releases the fatty acids, which may result in particle formation. Hydrolysis can be enzyme or chemically mediated, although enzyme-induced degradation is more common. Residual host cell proteins are present in the formulation buffer, including enzymes, such as lipases or esterases.

Poloxamers are an increasingly popular surfactant, both in protein-based and adeno-associated virus formulations. Poloxamers are made of one block of poly(propylene oxide) (PPO) and two blocks of poly(ethyleneoxide) (PEO) that attach to either side of the PPO. A major advantage of poloxamer is that it is not prone to hydrolysis. However, it is prone to oxidation, including auto-oxidation due to oxygen in the backbone of PPO and PEO. Similarly to polysorbate, oxidative products from degradation of poloxamers may cause the biologic or other formulation components to oxidize.