Manufacturing of Biotechnological Drug Products

This course aims to provide students with knowledge on the following topics:
- industrial processes used in the production of medicinal products of biotechnological origin;
- organization of manufacturing in a pharmaceutical company with specific reference to the production of finished products containing substances of biotechnological origin;
- cell therapy and advanced therapy medicinal products;
- legislative framework defining the requirements necessary for marketing application of medicinal products according to EC regulations.

At the end of the course, the student will acquire the necessary knowledge to understand the preparation processes of the biotechnology products, both based on proteins and monoclonal antibodies and belonging to the category of the Advanced Therapy Medicinal Products (ATMPs), i.e., based on genes and cells. The student will also acquire basic technological knowledge related to unconventional products, such as liposomes, complex generics and nano-systems. The student will also learn about the organization of a pharmaceutical industry and regulatory aspects of the aforementioned products.
Based on this competence, the student will be able to apply the knowledge acquired to understand and identify the critical aspects, both technology- and regulatory-related, of the biotechnology products.