The course aims to provide students with the basic notions of biological drugs, with particular attention to the new generation ones, to whose development the introduction of recombinant DNA technology and the progress in the use of monoclonal antibodies have significantly contributed. The development, production, therapeutic and clinical applications of biological drugs currently on the market, as well as the new therapeutic frontiers, will then be examined. In addressing the various topics, aspects relating to the different pathologies treated, as well as the mechanisms of action of the related drugs, will be examined.

1. Introduction to biologics

1.1 History of biologics

1.2 The revolution of bio (techno) logical drugs

1.3 Economic aspects

2. Recombinant proteins

2.1 General aspects

2.2 Production and purification

2.3 Analytical techniques

2.4 Pharmacokinetics and pharmacodynamics

2.5 Immunogenicity

3. Monoclonal antibodies

3.1 Structure and classes

3.2 Mechanisms of action

3.3 Translational aspects

3.4 Absorption, distribution and elimination

3.5 Interactions with other drugs

4. Economic aspects of biologics

5. Biosimilars

5.1 Regulatory aspects

5.2 Future prospects

6. Therapeutic and clinical applications of biological drugs

6.1 Insulin

6.1.1 Diabetes

6.1.2 Structure and functions of insulin

6.1.3 Pharmacology and formulations

6.1.4 Clinical aspects

6.2 Growth hormone

6.2.1 Structure and hormonal analogues

6.2.2 Pharmacology

6.2.3 Formulations, administration and PK

6.2.4 Clinical use

6.3 Coagulation factors and recombinant thrombolytic agents

6.3.1 Hemophilia

6.3.2 Factor VIII

6.3.3 Factor VIIa

6.3.4 Factor IX

6.3.5 Factor XIII

6.3.6 First generation thrombolytic agents

6.3.7 Clinical usage

6.3.8 Second-generation thrombolytic agents

6.4 Recombinant deoxyribonuclease I

6.4.1 Structure and function

6.4.2 Cystic fibrosis

6.4.3 Pharmacology

6.4.4 Drug delivery

6.4.4 Clinical use

6.5 Monoclonal antibodies in cancer

6.5.1 Antibodies directed against CD antigens

6.5.2 VEGF inhibitors

6.5.3 EGFR inhibitors

6.5.4 Antibodies directed against CTLA-4

6.5.4 Antibodies directed against PD-1 and PD-L1

6.6 Haemopoietic growth factors

6.6.1 Erythropoiesis stimulating agents

6.6.2 Myeloid growth factors

6.7 Monoclonal antibodies in the treatment of inflammatory states

6.7.1 Introduction

6.7.2 Arthritis

6.7.3 Lupus erythematosus

6.7.4 Psoriasis

6.7.5 Allergic asthma

6.7.6 Multiple sclerosis

None.

Knowledge and understanding - The student will have to demonstrate to have acquired the basic knowledge relating to biological drugs and biotechnological methodologies for their development and production. The student will also have to demonstrate to be familiar with the main groups of biological drugs currently on the market, the pathologies for which they are used, their pharmacology and their mechanism of action. Finally, the student will have to demonstrate knowledge of the therapeutic and clinical applications of biological drugs.

Ability to apply knowledge and understanding - The student will have to demonstrate mastery of the subject and be able to independently assess the use of biotechnological techniques that will be treated according to a specific context (development, formulation, production). The student must also demonstrate to have acquired specific language properties for the subject of the course.

Autonomy of judgment - The student must be able to critically elaborate the notions provided during the course and to independently evaluate the results of the analytical techniques addressed during the course.

Communication skills - The student must demonstrate tto have command of the language of the subject of the course and to be able to correctly expose the technical and scientific concepts that will be treated.

Learning skills - The student must demonstrate to have acquired the ability to independently find information about the subject of the course by consulting the related scientific publications. This ability will be encouraged, as far as possible, by the teacher through specific in-depth studies that students will be able to conduct independently and which 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

Teaching

The course will take place through lectures in which the teacher exposes, through visual aids (slides), the fundamental notions and provides practical examples to facilitate understanding. The teacher will try to involve students during the teaching activity also in order to verify the effectiveness of the tools used and the understanding of the topics covered.

Attendance

There are no attendance obligations but attendance at the course is strongly recommended.

Course books

1)    Crommelin, Sindelar, Meibohm - Pharmaceutical Biotechnology, Fundamentals and Applications, Fourth Edition – Springer

2)    Rodney – Biotechnology and Biopharmaceuticals, Trasforming Proteins and Genes into Drugs, Second Edition - Wiley

Other teaching material produced by the teacher will be made available to students during the course.

Assessment

In order to verify the preparation at the end of the course, the student will have to take an oral test aimed at verifying the understanding of the main aspects concerning biological drugs and the therapeutic approaches associated with them. The critical processing capacity of the topics covered during the course and the quality of the student's oral presentation will also be assessed. The teacher will also verify the acquisition of knowledge related to therapeutic and clinical applications of specific types of drug.

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 will use the materials (slides) produced by the teacher to complete their preparation. If necessary, the teacher can be contacted for further information.

Attendance

There are no attendance obligations but attendance at the course is strongly recommended.

Course books

1)    Crommelin, Sindelar, Meibohm - Pharmaceutical Biotechnology, Fundamentals and Applications, Fourth Edition – Springer

2)    Rodney – Biotechnology and Biopharmaceuticals, Trasforming Proteins and Genes into Drugs, Second Edition - Wiley

Other teaching material produced by the teacher will be made available to students during the course.

Assessment

In order to verify the preparation at the end of the course, the student will have to take an oral test aimed at verifying the understanding of the main aspects concerning biological drugs and the therapeutic approaches associated with them. The critical processing capacity of the topics covered during the course and the quality of the student's oral presentation will also be assessed. The teacher will also verify the acquisition of knowledge related to therapeutic and clinical applications of specific types of drug.

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.