1. Introduction to biologics

1.1 Definition

1.2 History of biologics

1.3 The revolution of bio (techno) logical drugs

1.4 Peculiarities of biologics

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 Chemical structure

6.1.2 Pharmacological aspects

6.1.3 Clinical aspects

6.2 Growth hormone

6.2.1 Structure and hormonal analogues

6.2.2 Pharmacology

6.2.3 Clinical use

6.3 Coagulation factors and recombinant thrombolytic agents

6.3.1 Factor VIII

6.3.2 Factor VIIa

6.3.3 Factor IX

6.3.4 Factor XIII

6.3.5 First generation thrombolytic agents

6.3.6 Second-generation thrombolytic agents

6.4 Recombinant deoxyribonuclease I

6.4.1 Structure and function

6.4.2 Pharmacology

6.4.3 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

6.6 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 Arthritis

6.7.2 Lupus erythematosus

6.7.3 Psoriasis

6.7.4 Allergic asthma

6.7.5 Multiple sclerosis

6.8 Interferons and interleukins

6.8.1 Interleukins

6.8.2 Therapeutic use of recombinant interferons

6.8.3 Therapeutic use of recombinant interleukins

6.8.4 Pegylated interferons and interleukins

6.9 Vaccines

6.9.1 Immunological principles

6.9.2 Classic vaccines

6.9.3 New generation vaccines

6.10 Oligonucleotides

6.11 Gene therapy

6.11.1 Viral vectors

6.11.2 Non-viral vectors

6.12 Stem cells

7. New frontiers: precision medicine

7.1 "Omic" technologies

7.2 Pharmacogenetics and pharmacogenomics

7.3 Personalized medicine

7.4 Epigenetics and epigenomics

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