The course provides a comprehensive overview of the regulatory aspects of Advanced Therapy Medicinal Products (ATMPs) and the scientific foundations of gene therapy, somatic cell therapy, and tissue engineering. Within the context of tissue engineering, special attention is given to the various types of scaffolds used, the biomaterials they are composed of, and the technologies employed for their production. Additionally, the course delves into the formulation and technological aspects of ATMPs, as well as industrial production in accordance with Good Manufacturing Practice (GMP) guidelines, including examples of production processes for gene therapy, somatic cell therapy, and tissue engineering. Finally, an overview of the entire drug development process for ATMPs is provided, spanning from production to clinical trials and through to marketing authorization.
- Teacher: Elia Bari