From Raw Materials to Finished Product

Detailed manufacturing instructions guide operations in all Lilly plants. When a product is developed, the recipe or formula is outlined step by step and followed exactly the same way regardless of what plant is producing it.

The active pharmaceutical ingredients are formed at bulk manufacturing facilities. Mixing specified raw materials produces a chemical reaction and creates a purified form of the medical molecule. Some drugs may require three or four such chemical reactions. To make insulin, for example, more than two dozen steps are required. For most products, the bulk drug typically emerges as a fluffy powder-like substance which is then shipped in large drums to Lilly's fill-finish manufacturing plants.

For tablets and capsules, the compound is mixed with other raw materials — inert substances such as starch, used as a vehicle for the drug. These "excipients" help shape the active substance into a form that makes it easy to swallow and metabolize in the body. Special tooling allows Lilly to put indentations on tablets that may need to be broken in half for flexibility in dosage. An oral liquid drug is produced by dissolving the powder in a liquid at a strength that allows for proper dosage. Then the product goes to packaging, where exact amounts of tablets, capsules, or liquids are packed in bottles or inserted into the cavities of "blister packs" that can be carefully sealed to protect the medicine.

For parenterals — medicines that are injected by syringe or intravenously — the active ingredients and excipients are dispensed through a sterile filtration process into sterile vessels, vials or cartridges. Alternatively, the ingredients may be freeze-dried into a powder plug which is then liquefied with purified water before being injected into a vial.

A tracking system keeps tabs on every step for every unit of the product. Everything is documented, from the raw materials to the packaging components, in case that audit information is needed later.