Formulation is the science and process of designing a stable, safe, and efficacious final drug product by combining a drug substance with appropriate excipients in a defined dosage form and delivery system. In biopharmaceutical manufacturing, formulation development encompasses buffer selection, pH optimization, stabilizer screening, concentration studies, and compatibility testing, with the goal of maintaining product integrity, potency, and shelf life throughout storage, transport, and administration. Formulations must comply with regulatory specifications defined by agencies such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA).
