This presentation was delivered at the CPhI tradeshow in Madrid, Spain on June 14, 2018.
Passports, ID cards, fingerprints, metal detectors, iris recognition, camera’s… we are trying to reveal the journey of “unknowns” to ensure safety and to avoid disaster. How is this different from an unknown in your drug product? Unknowns can pop-up during release testing, stability testing and leachable testing. These impurities are often related to the material or interaction of the material with the drug. Different case studies will be presented to demonstrate that material knowledge will allow you to reveal the journey of most of these unknowns and impurities. So you will gain control by knowing the origin of species.
Presenter: Lise Vanderkelen