Preparation and Development of Drugs with Biotechnological Methods

The main learning objective of this integrated course is to highlight the great power of biotechnological methods for the production of drugs as well as for the optimization of existing drugs and the development of new drugs. The course aims at developing critical skills in relation to the pharmacokinetic issues that may limit the efficacy of biotechnological drugs; the possible chemical or biotechnological modifications useful to tune up the pharmacokinetic parameters are analysed and discussed. The course is focused on two main classes of biotechnological compounds: recombinant proteins and natural products and their derivatives, obtained using biotechnological methods.
The course gives an overview of the main classes of biotechnological drugs, starting from the history of their development, through the study of the structure-activity relationship until the development of new derivatives characterized by a better pharmacological profile, including also some examples of drugs that are currently under clinical evaluation.
In parallel, the course analyzes the strategies, based on the use of biocatalysis and industrial biotechnology, for the large scale production of biologically active natural compounds (traditionally obtained from natural sources by conventional fermentation and/or extraction processes), or new derivatives with improved pharmacological profiles.

By the end of the course, students will have to know the main structural features of each class of drugs studied and they should be able to critically discuss the structure-activity relationships. In particular, they should be able to recognize the essential pharmacophoric groups and to discuss the possible modifications useful to optimize the pharmacokinetic and pharmacodynamic properties. Students should be able to propose a biotechnological method useful for the preparation of a given compound as well as the most adequate methods for structural modifications aiming at the optimization of the biological activity.
Finally, students should be able to correctly understand the questions posed during the final test, choose, elaborate and logically connect the information acquired within the course and communicate them effectively, using appropriate scientific language.