Securing Protein Stability With Low-NPI Sucrose

By Nelli Erwin, Senior Manager in Liquid Formulation R&D

For a biopharmaceutical formulation to be safe and effective, it’s critical that the therapeutic protein is chemically and physically stable. Degradation of the protein, such as by aggregation, would result in a loss of pharmacological activity and possibly trigger adverse effects. For this reason, a biopharmaceutical formulation typically includes a stabilizer. Excipients commonly used for this purpose include sugars such as sucrose and trehalose, as well as sugar alcohols like mannitol. While these have been in widespread use for a long time, only recently has it been discovered that they themselves may induce instabilities.