The course aims to provide students with the basics of biological drugs, focusing on new-generation drugs whose development was determined by the introduction of recombinant DNA technology and the advances in the use of monoclonal antibodies. Aspects relating to the development, production, therapeutic, and clinical applications of currently marketed biological drugs, as well as new therapeutic frontiers, will then be examined. 

Introduction to the course
A bit of history
Definition of biological and biotechnological drugs
Main characteristics of biological drugs and differences with small molecules
Use of genetic engineering
Biophysical and biochemical characteristics of proteins
Recombinant proteins
Therapeutic target identification and technological innovation in pharmacology
Development, production, and purification of recombinant proteins
Techniques for evaluating protein features
Formulation of biotechnological products
Pharmacokinetics and pharmacodynamics
Adverse effects
Antibodies and derivatives
Hormones
Enzymes
Hematopoietic growth factors
Coagulation factors
Cytokines and interferons
Vaccines
Oligonucleotides
Personalized medicine
Cells as drugs
Gene therapy
Stem cell technology
Pharmaceutical legislation and biosimilars

None

Knowledge and comprehension - The student should demonstrate basic knowledge of biological drugs and the biotechnological methodologies for their development and production. The student is also expected to demonstrate familiarity with the main groups of biological drugs currently on the market, the pathologies for which they are used, their pharmacology, and mechanism of action. Finally, the student must demonstrate knowledge of biological drugs' therapeutic and clinical applications.

Ability to apply knowledge and understanding - The student is expected to demonstrate that he/she has mastered the subject and can independently assess the use of the biotechnological techniques in a specific context (development, formulation, production). The student will also have to prove that he/she has acquired a language proper and specific to the discipline covered by the course.

Autonomy of judgment - The student will have to be able to critically elaborate on the notions provided during the course and to autonomously evaluate the results of the analytical techniques discussed during the course.

Communication skills - The student will have to demonstrate that he/she has mastered the language proper of the course matter and correctly explain the technical and scientific concepts that will be covered.

Learning ability - The student must demonstrate that he/she has acquired the ability to independently find information about some topics of the course by consulting the relevant scientific publications. This ability will be encouraged, as far as possible, by the lecturer through specific in-depth studies that students will conduct independently and that will be discussed in the classroom.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

During the course, a research paper will be presented and discussed to enable both the lecturer and the students to assess the degree of preparation and effectiveness of the method of study of the subject in relation to the program so far. 

Teaching

The course will be held in the form of lectures in which the lecturer uses visual aids (slides) to explain the fundamental notions and provides practical examples to aid understanding. The lecturer will also try to involve the students during the teaching activity in order to verify the effectiveness of the tools used and the understanding of the topics covered.

Innovative teaching methods

Debate - How to adopt regulated debate in universities

Problem-based learning  - For problem-based learning in small groups

Flipped classroom  - Flipped learning in academic teaching

Learning by doing  - (Simulation of scenarios, etc.)

CLIL - Content and language integrated learning

Attendance

There is no compulsory attendance but participation in the course is strongly recommended.

Course books

- Pharmaceutical biotechnology - fundamentals and applications. Crommelin, Sindelar, Meibohm - Fourth Edition - Springer

- Biotechnology and biopharmaceuticals - transforming proteins and genes into drugs. Ho, Gibaldi - Second Edition - Wiley.

- Pharmaceutical biotechnology - fundamentals and applications. Crommelin, Sindelar, Meibohm - Fourth Edition - Springer

- Biotechnological drugs - pharmacological and clinical aspects - Elisabetta Vegeto Adriana Maggi Paola Minghetti - Casa Editrice Ambrosiana. Exclusive Zanichelli distribution.

- Slides uploaded on Moodle platform - blended.uniurb.it
 

Assessment

- Oral test on at least three topics covered in the Biological Drugs course.

- Presentation and discussion in Italian/English of a research paper chosen by the student based on the topics covered in the Biological Drugs course that will contribute to the final mark.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

Teaching

Non-attending students may use the slides provided by the lecturer and the recommended texts to deepen their knowledge. The lecturer is available to provide further information on request in order to better guide students in their preparation.

Attendance

There is no compulsory attendance but participation in the course is strongly recommended. A basic knowledge of biochemistry and pharmacology is required.

Course books

In order to give non-attending students the opportunity to compensate with self-study what is done during the lectures, the following materials referring to the same contents of the program are indicated in order to promote a full understanding.

- Pharmaceutical biotechnology - fundamentals and applications. Crommelin, Sindelar, Meibohm - Fourth Edition - Springer

- Biotechnology and biopharmaceuticals - transforming proteins and genes into drugs. Ho, Gibaldi - Second Edition - Wiley.

- Pharmaceutical biotechnology - fundamentals and applications. Crommelin, Sindelar, Meibohm - Fourth Edition - Springer

- Biotechnological drugs - pharmacological and clinical aspects - Elisabetta Vegeto Adriana Maggi Paola Minghetti - Casa Editrice Ambrosiana. Exclusive Zanichelli distribution.

- Slides uploaded on Moodle platform - blended.uniurb.it

Assessment

- Oral test on at least three topics covered in the Biological Drugs course.

- Presentation and discussion in Italian/English of a research paper chosen by the student based on the topics covered in the course of Biological Drugs that will contribute to the final mark.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

The examination may be carried out in English if required by the student.