Compounding and filling: drug substance to drug product

A significant number of manufacturing steps are performed which ultimately result in the drug product. These steps include manufacture and storage of the bulk drug substance, which is frozen or kept as a liquid at 2–8 °C. The compounding process utilizes the bulk drug substance and other formulation components, such as buffers and excipients, to form the drug product. The drug product is then filled into primary containers, stoppered, capped, and inspected. Following this process, the drug product is placed in secondary packaging and shipped to its destination.