Perspectives of manufacturing of active pharmaceutical ingredients + advances in preformulation studies.

Report will be delivered on translation of the discovery synthesis of API(s) into technology development and on investigation of the solid state physicochemical characteristics of API(s). The Deliverable will contain observations, results and discussion of results against the state of the art obtained within the duration of ORBIS on the improvement of unfavorable characteristics of API(s) and describe: - synthesis of drug substances including scale-up and continuous model development - validation of analytical methods - process development of key synthetic transformations - intrinsic and derived solid state physicochemical properties of selected API(s) - preparation of crystalline and/or amorphous forms of selected API(s) - correlation between physicochemical properties of API(s) and formulability, manufacturability and biopharmaceutical performance