Protein Engineering, Drug Delivery and Regulatory Aspects

The course aims to explore the development, formulation, manufacturing and marketing of Biotechnological and Advanced Therapy Medicinal Products. The course is divided in three modules covering: (i) the key-concepts and tools to understand the molecular strategies behind the rational design of proteins having new functions or activities, (ii) the biopharmaceutic aspects and the design of drug delivery systems intended for the main routes of administration, and (iii) the regulatory aspects related to their manufacturing and marketing.

At the end of the course, students will have acquired the knowledge and methods enabling them to study and think, critically and independently, about different issues of medicines for human use, with reference to biotechnological medicinal products. The students will learn how to rationally design, or modify, protein structures and activity. They will know the basis on how to approach this problem, and to propose solutions for implementing and improving protein functions according to a specifically requested need. They will know how to edit the genome of cells and even organisms with the aim of potentially crate new GMOs. Also, they will know how to set-up experiments for the high-scale production of proteins and characterize them post-production.
Based on the physico-chemical features of an active ingredient and the selected parenteral route of administration, the student will be able to choose the optimal technological approach to the design and manufacture pharmaceutical dose forms satisfying the criteria of quality, safety and efficacy.
Moreover, students will be able to recognise what is, and what is not, a medicinal product, and outline the steps required to place a medicinal product on the market, with particular reference to biotechnological and advanced therapy medicinal products. They are expected to be able to retrieve and understand the relevant parts of EU legislative acts.
Students will be also able to correctly understand the questions in the learning verification phase, to know how to elaborate and connect the knowledge acquired in all the didactics units of the course.