Biotechnology and Pharmacotoxicology
A.Y. 2025/2026
Learning objectives
The main objectives are:
1. to compare the characteristics of small molecule drugs, biotechnological agents, biosimilars and bioequivalent drugs
2. to characterize their molecular mechanisms of action, and to identify the mechanisms at the basis of the toxicity of small molecule drugs and biotechnological agents
3. to gain knowledge on the processes leading to the development and manufacturing of recombinant proteins for therapeutic use and on the possible related quality and safety issues
4. to learn about cell and gene therapy and their possible applications
5. to provide notions for a correct characterization and interpretation of genotoxic, cancerogenic, immunotoxic and reproductive adverse effects of xenobiotics.
6. to provide notions on preclinical toxicology for product development and the EU legislations concerning the following endpoints: genotoxicity, cancerogenicity, immunotoxicity, reproductive and developmental toxicity.
Lectures will be dedicated to the introduction of the different topics and their toxicological evaluation, while the tutorials will be dedicated to the discussion of current OECD guidelines and case studies with a direct involvement of students.
1. to compare the characteristics of small molecule drugs, biotechnological agents, biosimilars and bioequivalent drugs
2. to characterize their molecular mechanisms of action, and to identify the mechanisms at the basis of the toxicity of small molecule drugs and biotechnological agents
3. to gain knowledge on the processes leading to the development and manufacturing of recombinant proteins for therapeutic use and on the possible related quality and safety issues
4. to learn about cell and gene therapy and their possible applications
5. to provide notions for a correct characterization and interpretation of genotoxic, cancerogenic, immunotoxic and reproductive adverse effects of xenobiotics.
6. to provide notions on preclinical toxicology for product development and the EU legislations concerning the following endpoints: genotoxicity, cancerogenicity, immunotoxicity, reproductive and developmental toxicity.
Lectures will be dedicated to the introduction of the different topics and their toxicological evaluation, while the tutorials will be dedicated to the discussion of current OECD guidelines and case studies with a direct involvement of students.
Expected learning outcomes
Students will be able to identify the possible critical steps which could pose safety issues during the whole life of a pharmacologically active entity, from its synthesis and development up to its distribution and therapeutic use. They will also gain basic knowledge on the consequences of drug-drug interactions in multidrug therapy and on the critical issues about gene and cell therapy. Students will learn the basic principles of genotoxicity, cancerogenicity, reproductive toxicity and immunotoxicity and their assessment.
The tutorials aim to stimulate the student toward critical thinking and problem solving, promoting his/her attitude to growth and constant improvement (lifelong learning). At the end, to assess the actual learning of the student, an oral examination of approximately 30 minutes on the topics and issues related to the evaluation of these critical toxicity endpoints as discussed during lectures will be done. In addition, students will perform a literature search on a topic of their interest and will discuss it in light of subjects presented during lectures. This will promote their critical thinking and will set the bases for their future ability to successfully face different problems and to identify unforeseen critical safety issues in the field of pharmacology and biotechnology.
The tutorials aim to stimulate the student toward critical thinking and problem solving, promoting his/her attitude to growth and constant improvement (lifelong learning). At the end, to assess the actual learning of the student, an oral examination of approximately 30 minutes on the topics and issues related to the evaluation of these critical toxicity endpoints as discussed during lectures will be done. In addition, students will perform a literature search on a topic of their interest and will discuss it in light of subjects presented during lectures. This will promote their critical thinking and will set the bases for their future ability to successfully face different problems and to identify unforeseen critical safety issues in the field of pharmacology and biotechnology.
Lesson period: Second semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Single session
Responsible
Lesson period
Second semester
In case of emergency, lessons will be hold on Teams.
Course syllabus
Professor Corsini module
Modern toxicology involves studying the structure and mechanisms underlying the toxic effects of chemical agents and incorporates technological advances in research related to the chemical aspects of toxicology. It is a highly multidisciplinary field that spans computational and synthetic chemistry, proteomics and metabolomics, drug discovery, drug metabolism and mechanisms of action, bioinformatics, bioanalytical chemistry, chemical biology, and molecular epidemiology. Integrating knowledge from these diverse areas is essential for accurate hazard identification and effective risk assessment.
Among the various possible adverse effects, those impacting the immune and reproductive systems, as well as genotoxic effects and carcinogenesis, deserve particular attention due to their significant implications for human health.
The main objectives of this module are to:
1. Provide foundational knowledge for the accurate characterization and interpretation of genotoxic, carcinogenic, immunotoxic, and reproductive adverse effects caused by xenobiotics.
2. Explore and explain the molecular mechanisms of action underlying these toxic effects.
3. Introduce key concepts in preclinical toxicology relevant to product development, alongside the European Union regulations addressing genotoxicity, carcinogenicity, immunotoxicity, and reproductive and developmental toxicity.
Lectures will focus on introducing these topics and their toxicological evaluation, while tutorials will engage students directly in discussing current OECD and ICH guidelines, fostering active participation and deeper understanding.
Professor Ceruti Module
Biotechnology and Pharmacology
Objectives:
The main objectives of the Biotechnology and Pharmacology module are:
1. to compare the characteristics of small molecule drugs, biotechnological agents, biosimilars and bioequivalent drugs
2. to identify the possible mechanisms at the basis of the toxicity of small molecule drugs and biotechnological agents
3. to gain knowledge on the processes leading to the development and manufacturing of recombinant proteins for therapeutic use and on the possible related quality and safety issues
4. to learn about cell and gene therapy and their possible applications
Program
- Introduction:
a. the drug discovery process with an historical perspective
b. prediction of adverse reactions and the evolution of clinical trials
- Biologics/Biosimilars, drugs/generics: characteristics and safety issues
- Therapeutic proteins: from synthesis to production and related safety issues
- Mechanisms of toxicity of small molecule drugs and of biotechnological agents
- Drug-drug and drug-natural compounds interactions
- Monoclonal antibodies: synthesis, characteristics and how their development affected regulatory agencies on clinical trials
- Cell and gene therapy: achievements, pitfalls and future perspectives
Modern toxicology involves studying the structure and mechanisms underlying the toxic effects of chemical agents and incorporates technological advances in research related to the chemical aspects of toxicology. It is a highly multidisciplinary field that spans computational and synthetic chemistry, proteomics and metabolomics, drug discovery, drug metabolism and mechanisms of action, bioinformatics, bioanalytical chemistry, chemical biology, and molecular epidemiology. Integrating knowledge from these diverse areas is essential for accurate hazard identification and effective risk assessment.
Among the various possible adverse effects, those impacting the immune and reproductive systems, as well as genotoxic effects and carcinogenesis, deserve particular attention due to their significant implications for human health.
The main objectives of this module are to:
1. Provide foundational knowledge for the accurate characterization and interpretation of genotoxic, carcinogenic, immunotoxic, and reproductive adverse effects caused by xenobiotics.
2. Explore and explain the molecular mechanisms of action underlying these toxic effects.
3. Introduce key concepts in preclinical toxicology relevant to product development, alongside the European Union regulations addressing genotoxicity, carcinogenicity, immunotoxicity, and reproductive and developmental toxicity.
Lectures will focus on introducing these topics and their toxicological evaluation, while tutorials will engage students directly in discussing current OECD and ICH guidelines, fostering active participation and deeper understanding.
Professor Ceruti Module
Biotechnology and Pharmacology
Objectives:
The main objectives of the Biotechnology and Pharmacology module are:
1. to compare the characteristics of small molecule drugs, biotechnological agents, biosimilars and bioequivalent drugs
2. to identify the possible mechanisms at the basis of the toxicity of small molecule drugs and biotechnological agents
3. to gain knowledge on the processes leading to the development and manufacturing of recombinant proteins for therapeutic use and on the possible related quality and safety issues
4. to learn about cell and gene therapy and their possible applications
Program
- Introduction:
a. the drug discovery process with an historical perspective
b. prediction of adverse reactions and the evolution of clinical trials
- Biologics/Biosimilars, drugs/generics: characteristics and safety issues
- Therapeutic proteins: from synthesis to production and related safety issues
- Mechanisms of toxicity of small molecule drugs and of biotechnological agents
- Drug-drug and drug-natural compounds interactions
- Monoclonal antibodies: synthesis, characteristics and how their development affected regulatory agencies on clinical trials
- Cell and gene therapy: achievements, pitfalls and future perspectives
Prerequisites for admission
The student must have basic knowledge of anatomy, biology, physiology, pathology, and pharmacology.
Teaching methods
Frontal lessons and tutorials. To facilitate the acquisition of the necessary skills and abilities to work effectively in teams and to achieve objectives (i.e. autonomy, ability to plan and organize and manage information) working groups will be organized.
Teaching Resources
Suggested study materials for Prof Corsini module:
- Casarett and Doull's Toxicology: The Basic Science of Poisons 8th Edition (Curtis D. Klaassen, Ed). Mc Graw Hill Education.
- Slides used during the lessons will be made available on MyARIEL.
- Recent reviews and OECD/ICH guidelines on the subjects will be made available on MyARIEL.
Suggested study materials for Prof Cerruti module:
- Slides provided by the teacher through MyARIEL
- Scientific articles provided by the teacher through MyARIEL website
- Textbook: Biotechnology and Biopharmaceuticals. Ho RJY, Gibaldi M - Wiley-Blackwell
- Textbook: Proteins. Biochemistry and Biotechnology. Walsh G - Wiley-Blackwell
- Textbook: Mechanistic Toxicology. Boelsterli UA - Taylor and Francis
- Casarett and Doull's Toxicology: The Basic Science of Poisons 8th Edition (Curtis D. Klaassen, Ed). Mc Graw Hill Education.
- Slides used during the lessons will be made available on MyARIEL.
- Recent reviews and OECD/ICH guidelines on the subjects will be made available on MyARIEL.
Suggested study materials for Prof Cerruti module:
- Slides provided by the teacher through MyARIEL
- Scientific articles provided by the teacher through MyARIEL website
- Textbook: Biotechnology and Biopharmaceuticals. Ho RJY, Gibaldi M - Wiley-Blackwell
- Textbook: Proteins. Biochemistry and Biotechnology. Walsh G - Wiley-Blackwell
- Textbook: Mechanistic Toxicology. Boelsterli UA - Taylor and Francis
Assessment methods and Criteria
Student learning will be assessed through an oral or written examination lasting approximately 30 minutes, focusing on the topics and key issues related to the evaluation of the specified toxicity endpoints, as discussed during the lectures.
Two separate examinations will be held, one for each module. The final grade will be calculated as the average of the two individual module marks.
Two separate examinations will be held, one for each module. The final grade will be calculated as the average of the two individual module marks.
BIO/14 - PHARMACOLOGY - University credits: 10
Tutorials: 16 hours
Lectures: 72 hours
Lectures: 72 hours
Professors:
Ceruti Stefania Maria, Corsini Emanuela
Professor(s)
Reception:
By telephone or e-mail appointment
Dip. di Scienze Farmacologiche e Biomolecolari 'Rodolfo Paoletti', Via Balzaretti 9, Milano