Pharmaceutical and biologic companies are the experts in understanding their drug products; this includes not only chemically synthesised small molecules but complex, large protein molecules. The final drug product is composed of the active ingredient and a complex mixture of excipients that provide benefits, such as an environment that helps to provide stability over shelf life. Fran DeGrazio at West Pharmaceutical Services, Inc explores how the ever-present and increasing regulatory and pricing pressures make for a significant challenge, even for the most experienced company with a good understanding of a drug product’s mechanism of function and side-effects.