Monoacyl phospholipids to replace polysorbates as interfacial stabilizers in parenteral monoclonal antibody formulations - Pharma Excipients

Monoacyl phospholipids to replace polysorbates as interfacial stabilizers in parenteral monoclonal antibody formulations - Pharma Excipients

Abstract Protein-based drugs are prone to both physical and chemical instability in aqueous solutions. Surfactants, such as polysorbates (PS), are commonly employed to mitigate interfacial stress, thus preventing protein aggregation and particle formation. However, polysorbates can undergo enzymatic hydrolysis by residual host cell proteins and oxidation during long-term storage in parenteral formulations. This can lead to the generation of fre…