Advanced therapy medicinal products (ATMP) represents a new class of medicinal products, which include - amongst others - somatic cell and gene therapies. As the final product is intended for administration into humans, manufacturers of ATMPs are obligated to apply good manufacturing practice (GMP) standards within their processes. Reaching and maintaining such standards is cost intensive and requires sophisticated manufacturing facilities. As a result, academic researchers who are developing these novel therapeutic approaches are facing new technological and financial challenges. In order to...
Advanced therapy medicinal products (ATMP) represents a new class of medicinal products, which include - amongst others - somatic cell and gene therap...