Biopharmaceutical Excipients
Definition: Biopharmaceutical excipients are pharmacologically inactive substances included in the formulation of therapeutic drugs—particularly complex biological products like monoclonal antibodies, vaccines, and gene therapies. Although they have no direct therapeutic effect, they are essential to the drug's performance.
Key Functions in Formulation:
Stabilization: They protect the sensitive biological active ingredient (protein, nucleic acid) from degradation caused by temperature, light, pH changes, or physical stress (like shaking during transport). This helps extend the drug's shelf life.
Examples: Sugars (like sucrose or trehalose) act as cryoprotectants.
