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Therapeutic proteins are inherently unstable and are sensitive to temperature change, shearing, shaking, solvents, ionic strength, purity, protein concentration, pressure and freeze/thaw-drying cycles. Of all the various degradation pathways possible, aggregation is one of the most common and a cause for great concern. Formulation is a key component that is required in order to produce a stable and efficacious biologic medicine.

Many excipients are used within biologic drug formulations, including a range of surfactants called polysorbates. As a potential functional alternative to surfactants within biologic formulations, KLEPTOSE􂡴 can act as an inhibitor of protein aggregation in liquid formulations by:

Shielding hydrophobic interactions to block potential protein-protein interaction which causes aggregation.

Displacing proteins induced by air-water interface.

Experiment objective

To benchmark KLEPTOSE® HP/HPB against polysorbates in commercial mAb formulations.


We have shown that KLEPTOSE® BioPharma (hydroxypropyl beta cyclodextrin) represents a promising alternative to surfactants  commonly used within biologic formulations, such as polysorbates Tween 20 and 80. Formulations containing KLEPTOSE® BioPharma perform better than the reference formulations containing polysorbates, when subjected to stress conditions of shaking (1400 rpm) and temperature (40°C). It represents a functional alternative to surfactants within biologic formulations.