Academic Year 2023/2024 - Teacher: Agostino MARRAZZO

Expected Learning Outcomes


The course aims to provide the basic knowledge of biotechnology methodologies for the design and the development of biotechnological drugs. The student will acquire the knowledge necessary to understand the principles for the expression of recombinant proteins in different expression systems (i.e., bacterial, yeast, insect, and mammalian), as well as the production, formulation, and characterization of biopharmaceuticals. At the end of the course, the student should develop fundamental laboratory skills and will be able to perform basic approaches for the manipulation of gene expression.

Course Structure

The course includes 28 hours of lectures and 30 hours of laboratory classes.

Class attendance is mandatory. The maximum limit of absences allowed is 30% of the total hours of lessons.

Should teaching be carried out in mixed mode or remotely, it may be necessary to introduce changes with respect to previous statements, in line with the programme planned and outlined in the syllabus.

The final exam is oral. Learning assessment may also be carried out on line, should the conditions require it.

Required Prerequisites

Passing and/or good knowledge of the following courses: General and Inorganic Chemistry, Animal and Plant Biology, Molecular Biology, Human Anatomy, Organic Chemistry, Analytical Chemistry, Microbiology, Biochemistry, General Physiology, Pharmaceutical and Toxicological Chemistry, Medicines and Pharmacology and Pharmacotherapy.

Detailed Course Content

  • Biotechnological and biomolecular methods for drug design and production. Gene manipulation and recombinant DNA technology.
  • Manipulation of genic expression and production of recombinant protein in prokaryotic and eukaryotic cells.
  • Downstream processing of protein products.
  • Therapeutic proteins: definition and classification. Hematopoietic growth factors. Interferons and interleukins. Insulin. GLP-1 analogues. Vaccines. Monoclonal antibodies.
  • Oligonucleotides (ON): The medicinal chemistry of ON, pharmacokinetics and toxicology. Antisense technology, aptamers, decoy, anti-genes, ribozymes, RNA-interference, micro-RNA.
  • Principles of structural bioinformatics.

Textbook Information

  1. Bibliography and notes provided during the course available online at:
  2. D. J. A. Crommelin & R. D. Sindelar, BIOTECNOLOGIE FARMACEUTICHE, Zanichelli.
  3. B. R. Glick, J. J. Pasternak, BIOTECNOLOGIA MOLECOLARE, Zanichelli.
  4. M. L. Calabrò, Compendio di BIOTECNOLOGIE FARMACEUTICHE, EdiSES.
  6. E. Vegeto, A. Maggi, P. Minghetti, FARMACI BIOTECNOLOGICI: aspetti farmacologici e clinici, Casa Editrice Ambrosiana.
  7. T. A. Brown, Biotecnologie molecolari: Principi e tecniche, Seconda edizione italiana, Zanichelli.
  8. G. A. Petsko, D. Ringe, Struttura e funzione delle proteine, Zanichelli.
  9. D. J. A. Crommelin, R. D. Sindelar, B. Meibohm. Pharmaceutical Biotechnology: Fundamentals and Applications, Fifth Edition.  Springer.
  10. G. Walsh. Pharmaceutical Biotechnology: Concepts and Applications, Wiley.
  11. T. Brown & Tom Brown (Jnr). Nucleic Acids Book, Atdbio.
  12. J. Sambrook, E. F. Fritsch, T. Maniatis, Molecular cloning: A laboratory manual, Second edition, Cold Spring Harbor Laboratory Press

Course Planning

 SubjectsText References
1Definition of pharmaceutical biotechnology and bioprocess development.Capitoli 1, 2 Compendio di BIOTECNOLOGIE FARMACEUTICHE, EdiSES. Bibliography and notes provided during the course available online at:
2Recombinant DNA technology. Large-scale production of recombinant proteins: design and production of biotechnological drugs.Capitolo 1 BIOTECNOLOGIE FARMACEUTICHE, Zanichelli. Capitolo 3 Compendio di BIOTECNOLOGIE FARMACEUTICHE, EdiSES.Bibliography and notes provided during the course available online at:
3Manipulation of gene expression in prokaryotes. Production of recombinant proteins in eukaryotic cells.Capitoli 6, 7 BIOTECNOLOGIA MOLECOLARE, Zanichelli. Bibliography and notes provided during the course available online at:
4Therapeutic protein. Cytokines. Vaccines. Monoclonal antibodies.Capitolo 8, 9, 10 BIOTECNOLOGIE FARMACEUTICHE, Zanichelli. Capitolo, 9, 12, 13. Compendio di BIOTECNOLOGIE FARMACEUTICHE, EdiSES. Bibliography and notes provided during the course available online at:
5Analytical techniques and purification of biological macromolecules.Capitolo 7. Compendio di BIOTECNOLOGIE FARMACEUTICHE, EdiSES.
6Oligonucleotides (ON): the "medicinal chemistry" of ONs, pharmacokinetics and toxicology. Antisense, aptamers, decoys, antigens, ribozymes, RNA-interference, micro-RNA. Bioinformatics.Capitolo 5 BIOTECNOLOGIA MOLECOLARE, Zanichelli. Capitolo 7-12 BIOTECNOLOGIE FARMACOLOGICHE, MASSON. Bibliography and notes provided during the course available online at:
7In order to pass the exam, there are no minimum required topics; the overall knowledge of required topics will be evaluated.The Professor provides the material necessary for the study of the topics covered in the classroom through the STUDIUM web application.