FARMACI BIOLOGICI E BIOTECNOLOGICI
Module MODULO 1 CHIMICA FARMACEUTICA

Academic Year 2025/2026 - Teacher: AGOSTINO MARRAZZO

Expected Learning Outcomes

Acquire basic knowledge of the methods used in the design and production of biotechnological drugs. This course will include the regulation of gene expression through operons, the protein purification process and its importance in biotechnological drug production, and the purification process of a new recombinant protein from a bacterial culture.

Course Structure

The course consists of 21 hours of face-to-face instruction.

If the course is taught in a blended or distance learning format, any necessary changes to the previously stated curriculum may be made in order to comply with the planned program and the syllabus.

Information for students with disabilities and/or learning disabilities (LDs):

To ensure equal opportunities and in compliance with applicable laws, interested students may request a personal interview to plan any compensatory and/or dispensatory measures, based on their learning objectives and specific needs.

You may also contact the CInAP (Center for Active and Participatory Integration - Services for Disabilities and/or LDs) contact teacher in our Department, Professor Santina Chiechio.

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.

Attendance of Lessons

Class attendance is mandatory. The maximum permitted absence limit is 30% of the total class hours, assessed in all their forms, as per the teaching regulations (LM 13 R_Farmacia.pdf).

Detailed Course Content

  • Course Contents
  • Definition of Pharmaceutical Biotechnology: Multidisciplinary Confluences in Biotechnology.
  • Development of Biotechnological Processes and Biotechnology Companies.
  • Recombinant DNA Technology. Large-Scale Production of Recombinant Proteins: Design and Production of Biotechnological Drugs.
  • Manipulation of Gene Expression in Prokaryotes. Production of Recombinant Proteins in Eukaryotic Cells.
  • Analytical and Purification Techniques for Biological Macromolecules.
  • Oligonucleotides (ONs): The Medicinal Chemistry of ONs, Pharmacokinetics, and Toxicology. Antisense, Aptamers, Decoys, Antigens, Ribozymes, RNA Interference, and MicroRNAs.

Textbook Information

Reference Texts: During the lecture, the most appropriate texts for studying the topic will be indicated.

Teaching Materials Provided by the Instructor: Studium UniCT

M. L. Calabrò, Compendium of Pharmaceutical Biotechnology, EdiSES.

D. J. A. Crommelin, R. D. Sindelar, B. Meibohm. Pharmaceutical Biotechnology: Fundamentals and Applications, Sixth Edition. Springer.E.

Vegeto, A. Maggi, P. Minghetti, BIOTECHNOLOGICAL DRUGS: Pharmacological and Clinical Aspects, Casa Editrice Ambrosiana.

F. Calabrese and G. Racagni, Principles of Medical and Pharmaceutical Biotechnology. Edra Publishing.

Course Planning

 SubjectsText References
1Definition of pharmaceutical biotechnology and bioprocess development.Capitoli 1, 2 Compendio di BIOTECNOLOGIE FARMACEUTICHE, EdiSES. Teaching materials provided by the instructor through the STUDIUM platform.
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. Teaching materials provided by the instructor through the STUDIUM platform.
3Manipulation of gene expression in prokaryotes. Production of recombinant proteins in eukaryotic cells.Capitoli 6, 7 BIOTECNOLOGIA MOLECOLARE, Zanichelli. Teaching materials provided by the instructor through the STUDIUM platform.
4Analytical techniques and purification of biological macromolecules.Capitolo 7. Compendio di BIOTECNOLOGIE FARMACEUTICHE, EdiSES.
5Oligonucleotides (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. eaching materials provided by the instructor through the STUDIUM platform.
6In 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.

Learning Assessment

Learning Assessment Procedures

Oral exam with a grade out of 30.

The assessment may also be conducted online, if circumstances require.

There are no minimum requirements for passing the exam; basic knowledge of the syllabus topics will be assessed.

Examples of frequently asked questions and / or exercises

Strong and tunable promoters used in biotechnology. Oligonucleotide (ON) technology. Fusion proteins, etc.