Polysorbates versus KLEPTOSE® HPBCD: Comparative Study of Their Stability and Monoclonal Antibody Stabilization Benefits

Polysorbates are intensively used in biologics formulations as a stabilizer due to their propensity to inhibit aggregation at interfaces but possess low intrinsic stability. In this study, the chemical stability of KLEPTOSE® HPBCDs are compared with polysorbates under various stress conditions.

When subjected to heat stress and other chemical stressors – autoclave, light and oxidative stresses – HPBCD remains almost stable while polysorbates show more severe degradation. Further, profiling characterization and degradation analysis reveal that HPBCD chemical structure remains intact while polysorbates undergo significant hydrolytic degradation and oxidation.

Lastly, the physicochemical stability of monoclonal antibody in formulations have been investigated using adalimumab as a model protein. When subjected to light stress, HPBCD-containing formulations show significant decreases in protein aggregation, as well as superior monomer and total protein recovery compared to polysorbate-containing formulations. HPBCD also reduces both agitation and thermal stress-induced protein aggregation and prevents subvisible particle formation compared to polysorbates.

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