Formulation and Quality – Biomolecular
2019 PharmSci 360
Protein instability is a major challenge to overcome for biopharmaceuticals. The selection of appropriate excipients to stabilize protein drugs during formulation development is critical in ensuring product stability against various physical stresses throughout its shelf life.
Formulations containing KLEPTOSE® HP and HPB were able to inhibit fragmentation of antibodies (human plasma IgG and Bevacizumab) under agitation, resulting in a significant higher % soluble monomer recovered as compared to controls. Stability study at 40 °C also showed that 100 mM KLEPTOSE® HP and HPB were superior in antibody aggregation reduction as compared to trehalose. During thermal ramp, NanoDSF results showed that KLEPTOSE® HP and HPB (100 mM) reduced the relative amount of protein aggregation and increased aggregation onset temperature.
In this study, we showed the effects of hydroxylpropyl-ß-cyclodextrin (KLEPTOSE® HP and HPB) in the stabilization of model antibodies, suggesting the function of KLEPTOSE® in extending shelf life of therapeutic proteins.