FARMACI BIOLOGICI E BIOTECNOLOGICIModule MODULO 3 TECNICA
Academic Year 2026/2027 - Teacher: TERESA MUSUMECIExpected Learning Outcomes
The course aims to provide students with basic knowledge of the formulation, technological, and biopharmaceutical aspects of the delivery of biological and biotechnological drugs, with an overview of the regulatory framework for medical therapy and the different development phases.
The course is structured around lectures with the introduction of active learning practices.
Students will acquire knowledge of the general aspects of the formulation development of protein-based, nucleic acid-based, and cell-based drugs. They will also acquire knowledge of the general aspects of current regulations regarding the development of biotechnological drugs.
EXPECTED LEARNING OUTCOMES
At the end of the course, students will be able to:
- Acquire knowledge of the various formulation strategies used to deliver biological and biotechnological drugs. An overview of the manufacturing processes of pharmaceutical forms and basic knowledge of the quality control tests to be applied to the finished product before its distribution.
- Understand the difference between traditional medicines and biological and biotechnological medicines.
- Describe guidelines and regulations governing the production and marketing of biological drugs.
Course Structure
The course is organized in frontal lessons. A limited number of classes may be taught in English. Optional in-depth will be provided on topics related to professor's research field. Additional optional in-depth lessons (honors courses) will be offered on innovative and current topics of interest in research field. If the course is delivered in blended or remote mode, appropriate adjustments may be made to the above, in order to ensure consistency with the syllabus.
Required Prerequisites
Attendance of Lessons
Detailed Course Content
Stability and limits in the delivery of: proteins, monoclonal antibodies, oligonucleotides, gene therapy, and vaccines
Stability and limits in the delivery of: proteins, monoclonal antibodies, oligonucleotides, gene therapy, and vaccines.
Dosage forms (excipients, process, route of administration) for the delivery of:
- Monoclonal antibodies
- Oligonucleotides and gene therapy
- Vaccines
- Proteins
- CAR-T
Clinically used in: oncology, immunotherapy, infectious diseases, and notes on preclinical dosage forms.
Notes on the regulation of biological and biotechnological drugs and quality assurance guidlines in the production process.
- Oligonucleotides and gene therapy
- Vaccines
- Proteins
- CAR-T
Clinically used in: oncology, immunotherapy, infectious diseases, and notes on preclinical dosage forms.
Notes on the regulation of biological and biotechnological drugs and quality assurance guidlines in the production process.
Textbook Information
1. Francesca Calabrese e Giorgio Racagni. Principi di Biotecnologie Mediche e Farmaceutiche. Edizioni Edra. 2025
2. Caliceti. Tecnologia Faramceutica. Edizioni CEA. 2025
3. E. Vegeto, A. Maggi, P. Minghetti. Farmaci Biotecnologici (aspetti farmacologici e clinici). Edizioni CEA. 2024.
Learning Assessment
Learning Assessment Procedures
Examples of frequently asked questions and / or exercises
What limits are encountered in protein delivery, and what strategies are employed to overcome them?
Oligonucleotide delivery using non-viral vectors