2021/2022

2021/2022

DM270

CHIM/08 (PHARMACEUTICAL CHEMISTRY)

DEPARTMENT OF MOLECULAR MEDICINE

MEDICAL AND PHARMACEUTICAL TECHNOLOGIES

PERCORSO COMUNE

1°

1st semester (04/10/2021 - 21/01/2022)

6

48 lesson hours

Italian

WRITTEN AND ORAL TEST

TERRENI MARCO (titolare) - 3 ECTS
MASSOLINI GABRIELLA - 1 ECTS
TENGATTINI SARA - 2 ECTS

The main objective of the course is to provide knowledge about the most common analytical techniques used for the characterization of therapeutic proteins (LC and LC-MS). At the end of the course, the student will be able to select the proper analytical approach to investigate a specific quality attribute of a biotechnological product (amino acid sequence, glycosylation profile, PTMs, aggregation tendency, charge variants..).

Proff G. Massolini/S. Tengattini

Short description of the main issues related to the production of biotechnological drugs.
- Role of analysis in pharmaceutical chemistry and in biotechnology.
- Criteria for the selection and the development of analytical methods for oligopeptides, polypeptides and proteins.
- Most common analytical techniques applied to the characterization of biopharmaceuticals: chromatography and mass spectrometry.
- Different liquid chromatography modes (reversed-phase, ion exchange, size exclusion, affinity, hydrophilic and hydrophobic) in the analysis of proteins and peptides of therapeutic interest.
- Most common approaches for protein purification, isolation and concentration.
- Theoretical aspects of mass spectrometry (MS): ion sources (ESI, MALDI), mass analyzers (ion trap, quadrupole, time of flight) and tandem MS.
- Application of MS to protein characterization.
For each analytical technique, theoretical aspects and main applications in biotechnology will be discussed, with particular emphasis on quality control aspects, such as identity, integrity, PTMs, thermal stability, tridimensional structure and folding.
Monographies from the European Pharmacopeia will be discussed.

Frontal classes and case studies.

Materials provided by the teachers (slides shown during lessons and other material, such as bibliographical references).

Analisi dei Farmaci Biotecnologici: written exam with multiple choice and open questions.