Stability Testing of Biopharmaceuticals

During this course you will get to know the relevant aspects of stability testing for biological and biotechnological drug substances and drug products. You will learn about

->The basic requirements of stability testing and stability study design from the supervisory authority’s view

->The peculiarities of stability indicating analytical methods

->optimising strategies regarding packaging and storage of biological/biotechnological material

->how to submit stability data for a marketing authorisation dossier according to the new Guideline on Quality Documentation