The HOS of a protein is a fingerprint that covers structural qualityĪttributes potentially linked to the function of the molecule.
(HOS: secondary, tertiary, and quaternary structure). That may be subjected to modifications following selected stress.Īmong CQA, special focus is devoted to the higher-order structure Provide the punctual characterization of the molecule’s CQA Or microbiological properties or characteristics that must fall withinĪppropriate limits, ranges, or distributions to ensure the optimal Of the degradation routes of formulation components under variousĪttributes (CQA) are physical, chemical, biological, Paradigm, formulation studies may benefit from the development ofĪnalytical methods, support of specification setting, and characterization This information is, in turn, capitalįor the evaluation of drug stability and the related impact on purity, Testing) are a key step for assessing protein degradation pathways
