OVERVIEW

The course provides 1 ECTS credit, corresponding to 8 hours of lectures. It enables students to understand the meaning of “biotechnological drug,” to distinguish it from chemically synthesized drugs, and to learn its classification, side effects, production methods, the stages of clinical trials required for marketing authorization, and the concepts of patient selection, conditioning, and premedication for those receiving a biotechnological therapy.

AIMS AND CONTENT

LEARNING OUTCOMES

The Biotechnological Drugs I module aims to define the concept of a biotechnological drug, illustrating its main characteristics and adverse effects, its classification, methods of production, and the stages of clinical trials required before it reaches the market. During the course, several examples of biotechnological drugs already in clinical use, as well as those potentially applicable in the near future, will be presented.

AIMS AND LEARNING OUTCOMES

The course aims to define the concept of a biotechnological drug, highlighting the differences compared to chemically synthesized drugs; to describe their classification, clinical applications, and adverse effects; and to illustrate the possible modifications that can be applied to optimize their efficacy and minimize their toxicity. It also specifically explains the concepts of gene therapy and recombinant DNA technology, providing examples of biotechnological drugs used in these contexts. Furthermore, it presents examples of biotechnological drugs used in clinical practice, such as monoclonal antibodies, recombinant proteins, antisense oligonucleotides, and stem cell therapies.

At the end of the course, the student will be able to:

• Distinguish a biotechnological drug from a traditional drug;
• Classify biotechnological drugs;
• Provide examples of modifications applicable to these molecules to improve efficacy or reduce side effects;
• Explain the mechanism of action, pharmacokinetics, and pharmacodynamics of some biotechnological drugs, with examples;
• Describe the characteristics of monoclonal antibodies, recombinant proteins, and antisense oligonucleotides, and their clinical use;
• Explain the concepts of recombinant DNA technology and gene therapy, providing examples of biotechnological drugs used in these experimental approaches;
• Describe the concept of cell therapy and the use of stem cells, with examples;
• Explain the phases of clinical trials for biotechnological drugs and the concepts of patient selection, conditioning, and premedication for those receiving such therapies.

PREREQUISITES

Knowledge of basic notions of biochemistry, organic chemistry, biology and immunology.

TEACHING METHODS

The course is organized in frontal lessons. The topics will be illustrated by the teacher through Powerpoint presentations that are shared on Aulaweb.

Any Student with documented Specific Learning Disorders (SLD), or with any special needs, shall reach out to the Lecturer(s) and to the dedicated SLD Representative in the Department (Prof. Luca Raiteri, Luca.Raiteri@unige.it ) before class begins, in order to liaise and arrange the specific learning methods and ensure proper achievement of the learning aims and outcomes. VERY IMPORTANT: any request for compensatory tools and adaptations in the exam MUST be done within 7 working days before the date of the exam according to the instructions that can be found at https://unige.it/disabilita-dsa/comunicazioni.

SYLLABUS/CONTENT

Topics covered in the course:

1. Differences between traditional drugs and biotechnological drugs.
2. Classification of biotechnological drugs.
3. Production of biotechnological drugs.
4. Side effects associated with the use of biotechnological drugs.
5. Post-translational modifications applicable to biotechnological drugs.
6. Mechanisms of action, pharmacokinetics, and pharmacodynamics of biotechnological drugs.
7. Phases of clinical trials for a biotechnological drug.
8. Market authorization of biosimilar biotechnological drugs.
9. Orphan drugs.
10. Identification of biological targets for biotechnological drugs.
11. Use and mechanism of action of oligonucleotides as biotechnological drugs.
12. Gene therapy: examples of biotechnological drugs.
13. Epigenetics: examples of epigenetic drugs.
14. Biotechnological drugs for rare diseases.
15. Clinical use of monoclonal antibodies and recombinant proteins.
16. Recombinant DNA technology.
17. Clinical use of antisense oligonucleotides.
18. Stem cell-based cellular therapy.
19. Patient selection, conditioning, and premedication for those receiving biotechnological drugs.
20. Ethical issues in biotechnology.

RECOMMENDED READING/BIBLIOGRAPHY

All materials used during the lectures will be made available on Aulaweb. For further study, the following texts are recommended:

• Farmaci biotecnologici, aspetti farmacologici e clinici, E. Vegeto, A. Maggi, P. Minghetti, Casa Editrice Ambrosiana, 2020.
• Farmaci Biotecnologici e terapie avanzate, F. Calabrese, R. Molteni, G. Racagni, Casa editrice Edra,2025.
• Principi di Biotecnologie mediche e farmaceutiche, F. Calabrese, G. Racagni, , Casa editrice Edra, 2025.

TEACHERS AND EXAM BOARD

LESSONS

LESSONS START

The timetable for this course can be found at: EasyAcademy Portal.

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam will consist of a written test with 3 open questions on the topics of all three 1 CFU modules (3 CFU total) lasting 1 hour and 30 minutes. To pass this test, the student must have obtained a passing grade in all three modules, otherwise he/she will have to repeat the entire written test. The written test can be taken only after having passed the 6 CFU immunology module.

ASSESSMENT METHODS

During the exam, the student will have to demonstrate the knowledge acquired during the lessons, also with connections to related disciplines.

FURTHER INFORMATION

Contact the teacher for further information not included in the teaching sheet.