Stability studies are systematic investigations conducted to evaluate how the quality, safety, potency, and purity of a drug substance or drug product evolve over time under defined storage conditions — including temperature, humidity, light exposure, and freeze-thaw cycles. They are a mandatory regulatory requirement for biopharmaceutical products, cell and gene therapies, and viral vectors, and must be designed in compliance with ICH Q5C (for biotechnological products) and ICH Q1A guidelines. Stability data inform shelf life determination, storage conditions, packaging specifications, and transport validation, and are a critical component of IND, BLA, and MAA regulatory submissions.
