B2824 - Biological Drugs

Learning outcomes

Upon completion of the course, students will:

• understand the structure, production, and post-translational processing of recombinant proteins, as well as the purification processes and therapeutic targets of marketed biopharmaceuticals;
• understand the different classes of therapeutic proteins and monoclonal antibodies, including their pharmacodynamic and pharmacokinetic properties;
• understand the efficacy, immunogenicity, and safety profiles of biopharmaceuticals and biosimilars;
• be able to apply the acquired knowledge in professional practice, including the proper storage and dispensing of biopharmaceuticals, providing patients with appropriate information and education on their use, and monitoring the appropriateness of prescribing and the continuity of adherence to pharmacological therapy, particularly in chronic treatments.

Course contents

GENETIC ENGINEERING AND RECOMBINANT DNA

• Gene cloning.
• Cellular genetic engineering for the production of therapeutic proteins.
• Methods for DNA transfer into cultured cells.
• Cell-based systems for the study and production of recombinant proteins.
• Cloning of a human gene.
• Post-translational protein modifications.
• Pharmacological applications of recombinant cell lines.
• Transgenic animals in drug research, development, and production.

MONOCLONAL ANTIBODIES

• Antibody structure.
• Antibody functions and recycling.
• Biotechnological production of antibodies.
• Hybridoma generation, growth, and selection.
• Chimeric, humanized, and fully human monoclonal antibodies. Modifications to improve the pharmacological properties of monoclonal antibodies.
• Antibody–drug conjugates (ADCs).

ADVANCED THERAPIES: GENE THERAPY

• Definition and principles of gene therapy.
• Gene therapy strategies and approaches.
• Ex vivo gene therapy.
• In vivo gene therapy.
• Gene therapy tools and technologies.
• Viral vectors as safe delivery systems for gene therapy.
• Clinical applications of gene therapy.
• Chimeric Antigen Receptor T-cell (CAR-T) therapy.
• In vivo gene therapy products.

TARGETED THERAPIES IN ONCOLOGY  

• Signal transduction pathways.
• Gene mutations in human cancers.
• Tyrosine kinase inhibitors.
• Targeted therapy against the BCR-ABL protein.
• Targeted therapies against EGFR and HER2/neu.
• VEGF and angiogenesis inhibitors.
• RAF and MEK kinase inhibitors.
• PI3K inhibitors.

• Development of targeted anticancer chemotherapy. Drugs targeting receptor tyrosine kinases.

PHARMACODYNAMICS AND PHARMACOKINETICS OF BIOTECHNOLOGICAL DRUGS

• Pharmacodynamics and pharmacokinetics of biopharmaceuticals.
• Safety of biological drugs and biosimilars.
• Clinical use of biotechnological medicines.

DRUGS FOR ONCOLOGY

• Therapeutic strategies in oncology.
• Monoclonal antibody therapies.
• Active immunotherapy.
• Cell-mediated therapies.
• Cytokine-based therapies.
• IL-6 inhibitors.
• IL-1 inhibitors.
• IL-12 and IL-23 inhibitors.
• Anti-IL-17 therapies.

DRUGS FOR THE IMMUNE SYSTEM

• Biotechnological drugs for chronic autoimmune inflammatory diseases.
• TNF-α inhibitors.

DRUGS FOR THE RESPIRATORY SYSTEM

• Biotechnological and innovative therapies for asthma.
• Anti-IgE antibodies.
• Anti-IL-5 therapies.
• Anti-IL-5 receptor therapies.
• Anti-IL-4 receptor therapies.
• Emerging molecules and novel therapeutic targets for asthma, including anti-IL-13 and anti-IL-17 therapies.

Readings/Bibliography

Elisabetta Vegeto Adriana Maggi Paola Minghetti

Farmaci biotecnologici: aspetti farmacologici e clinici. Casa Editrice Ambrosiana. Zanichelli

Teaching methods

The course consists of face-to-face lectures.

Lectures are supported by slide presentations that serve as a guide for both the instructor and the students. Students are encouraged to interact with the instructor and ask questions to clarify the topics covered during the lectures.

Assessment methods

Assessment is conducted through an oral examination. The purpose of the examination is to evaluate the student's knowledge of the topics covered during the lectures of the module.

Each module may be taken separately.

The final grade is calculated as the average of the grades obtained in each module.

With regard to assessment, the use of artificial intelligence (AI) is prohibited. Any use constitutes a violation of academic integrity.

Teaching tools

Teaching equipment: Computer and multimedia projector.

Teaching materials: PowerPoint presentations will be made available to students on the Virtuale learning platform prior to each lecture.

 

Students with Specific Learning Disorders (SLD) or temporary or permanent disabilities are encouraged to contact the University's relevant support office as early as possible (https://site.unibo.it/studenti-con-disabilita-e-dsa/it ). The office will propose any appropriate accommodations for eligible students. Such accommodations must be submitted to the course instructor for approval at least 15 days in advance. The instructor will assess their suitability, taking into account the learning objectives of the course.

Office hours

See the website of Gloria Ravegnini

See the website of Jessica Marinello