One of the challenges on the way to commercialization is the transition from preclinical development to the clinical stage. This transition involves, amongst others, key considerations regarding the raw materials that are used in the manufacturing process. Whereas the safety and quality of raw materials often have a lower priority in the initial preclinical phase, they are crucial in the late clinical phases and commercial production.
To enable a seamless transition we recommend identifying the appropriate GMP grade raw materials and reliable suppliers already during early stage preclinical research and prior to clinical development of an ATMP. Changing raw materials at a late stage in clinical development in order to meet the increased regulatory requirements often creates significant additional costs and loss of precious time.