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Promising alternative to surfactants commonly used within biologic formulations, such as polysorbates Tween 20 and 80. 

Challenge

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.

Conclusion

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.

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