Formulation and Quality – Biomolecular
2019 PharmSci 360
Polysorbate 80 (PS80) is commonly used in formulations to mitigate interface-induced protein aggregation. The functionality of polysorbate in particular with respect to new grades, as all-oleate PS80 compliant with the Chinese Pharmacopoeia (PS80-AO) is a highly relevant and not yet well understood field.
The functionality of two PS80 grades (Ph.Eur., USP, and JP complaint = PS80-MC and PS80-AO), as well as degraded PS80 (hydrolyzed) to stabilize a monoclonal antibody (IgG) against mechanical stress will be presented. No significant differences in PS80 functionality between the two grades (PS80-MC and PS80-AO) were observed based on aggregation (HP-SEC) and the formation of particles. Furthermore, with increasing amount of hydrolyzed PS80, higher counts of sub-visible particles were measured after stress.