LABORATORY OF PHARMACEUTICAL BIOTECHNOLOGY - LABORATORY OF EXTRACTIVE AND SYNTHETIC PREPARATION OF DRUGS A - L

Module Laboratory of PHARMACEUTICAL BIOTECHNOLOGY

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.

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.

• 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.

1. Bibliography and notes provided during the course available online at: http://studium.unict.it/dokeos/2021/
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.
5. A. Maggi, BIOTECNOLOGIE FARMACOLOGICHE, MASSON.
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. https://www.atdbio.com/nucleic-acids-book.
12. J. Sambrook, E. F. Fritsch, T. Maniatis, Molecular cloning: A laboratory manual, Second edition, Cold Spring Harbor Laboratory Press