Spotlight on stability: API and drug product testing

Stability studies are key to drug development. An integral part of any New Drug Application (NDA) is a requirement to perform stability studies on active pharmaceutical ingredients (APIs) and drug products to assess degradation and inform shelf-life prior to market release. For some programmes, further investigation is required to demonstrate stability of key raw materials, intermediates or excipients used in the manufacturing process. Anna Cousens, Business Development Manager at Almac Sciences, describes what studies need to be performed, and how, to ensure the best product performance.