DESIGN OF BIOPHARMACEUTICALS

Degree course: 
Corso di Second cycle degree in Biotechnology for the Bio-based and Health Industry
Academic year when starting the degree: 
2021/2022
Year: 
1
Academic year in which the course will be held: 
2021/2022
Course type: 
Compulsory subjects, characteristic of the class
Language: 
English
Credits: 
6
Period: 
Second semester
Standard lectures hours: 
52
Detail of lecture’s hours: 
Lesson (40 hours), Exercise (12 hours)
Requirements: 

Basic knowledge of Biochemistry, Structural biochemistry, Pharmacology, Enzymology, and Organic Chemistry.

Final Examination: 
Orale

The examination is designed to assess the skills acquired by the student concerning the topics of the course. The exam is organized in two parts: it consists in a written evaluation related to the theory (this mode is to be considered preferential, but it may be modified based on further indications coming from the University) and in a written report concerning computational trials.
The written exam is made of four questions: the students will demonstrate the theoretical knowledge about design of biopharmaceuticals. This part corresponds to 2/3 of the final score.
The report will describe the results gathered from computational evaluations. This part corresponds to 2/3 of the final score.
The final score of the course is given in 30ies and it is the average of the scores of each part: the examination is successful if a score > 18/30 is gained in each part.

Assessment: 
Voto Finale

Design of biopharmaceuticals is a course in which concepts of chemistry, organic chemistry and biochemistry acquired during the previous courses are employed to understand the mechanism of action and the strategies for the design of new generation of biotechnological drugs. The course is aimed at the description of the bases of drug action (both small- and macro-molecules) and of the physiological/pathological functions of their targets, as well as at the description of new classes of drugs (for example, antibodies and therapeutic proteins). The course aims to provide the basis for a comprehensive understanding of the strategies of rational drug design.

Learning outcomes
At conclusion of this course the student will:
1. identify the main factors of drug action (bioavailability and mechanism of action at their targets);
2. know the main approaches to design biotechnological drugs, also from a computational point of view;
3. use the acquired knowledge design strategies and approaches to drug design;
4. understand and critically evaluate both the theoretical and practical examples form literature related to design of novel biotechnological drugs;
5. demonstrate effective communication skills and with adequate scientific terminology, both oral and written way;
6. demonstrate to resume and show the information as a written report (also referred to chemical interactions and description of complex macromolecular structures).

The course consists of 40 hours of frontal lessons (5 CFUs). Lessons are supported by PPT slide projection.
Tutorial: 12 hours (1 CFU). Individual practical exercitation using a computer.

Lectures:
Design of Biopharmaceuticals, theory and examples - 4.0 CFU (32 hours):
- Introduction to pharmacology and drug design
- The structure of proteins and structure/function relationships in proteins with are target of drugs
- Design of novel drugs. Molecular medicine, virus and viral drugs
- Therapeutic proteins and modification of therapeutic proteins
- Drugs altering the protein interactions
- Amyloids and strategies to treat Alzheimer’s disease
- Biosimilars
- Seminars of case histories
Bioinformatic tools for the design of a pharmaceutical drugs – 1 CFU (8 hours)
- Introduction to data banks relevant for drug design
- Introduction to computational tools for structure-based drug design

Tutorials: Simulation of the design of a pharmaceutical drug – 1 CFU (12 hours)
- Molecular modelling in structure-based drug design.
- Visualization of macromolecule-drugs complexes
- Use of molecular docking to evaluate the drug-protein interaction

Lectures:
Design of Biopharmaceuticals, theory and examples - 4.0 CFU (32 hours):
- Introduction to pharmacology and drug design
- The structure of proteins and structure/function relationships in proteins with are target of drugs
- Design of novel drugs. Molecular medicine, virus and viral drugs
- Therapeutic proteins and modification of therapeutic proteins
- Drugs altering the protein interactions
- Amyloids and strategies to treat Alzheimer’s disease
- Biosimilars
- Seminars of case histories

Bioinformatic tools for the design of a pharmaceutical drugs – 1 CFU (8 hours)
- Introduction to data banks relevant for drug design
- Introduction to computational tools for structure-based drug design

Tutorials: Simulation of the design of a pharmaceutical drug – 1 CFU (12 hours)
- Molecular modelling in structure-based drug design.
- Visualization of macromolecule-drugs complexes
- Use of molecular docking to evaluate the drug-protein interaction

“Farmaci biotecnologici, aspetti farmacologici e clinici”, Elisabetta Vegeto Adriana Maggi Paola Minghetti, Zanichelli, 2021
Slides of lessons: from the Elearning website.
Lecture notes and scientific papers: from the Elearning website.
Open source/freeware softwares.

Convenzionale

Class lessons (with Power Point presentations) with presentation and critical analysis of specific topics; specialistic seminars: 40 hours
Class tutorials: 12 hours

Students can meet with the professor in his/her study by previous phone or email appointment.