- Docente: Vincenza Andrisano
- Credits: 3
- SSD: CHIM/08
- Language: English
- Teaching Mode: Traditional lectures
- Campus: Rimini
- Corso: Single cycle degree programme (LMCU) in Pharmacy (cod. 9078)
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from Sep 30, 2022 to Nov 21, 2022
Learning outcomes
The student has the knowledge of the fundamental aspects related to the chemical study of biotechnological drugs (mechanism of action at the molecular level and structure-activity relationship); learns the theoretical and applicative aspects of the analytical methodologies for the structural and stereochemical characterization of biotechnological drugs. The students learns how to deal with the analytical issues related to the quality control of biotechnological drugs and bio-similars.
Course contents
•Main issues related to initial and complete characterization of biopharmaceuticals, especially peptides, proteins, antibodies and antibody-drug conjugates. •Levels of complexity: how to analytically face them? •Top down and bottom up mass spectrometric methods for characterizing protein biotherapeutics. •Current MS-based approaches; Hyphenated analytical techniques and their application in the analysis of peptides and proteins. •Structural characterization of intact biopharmaceuticals; assessment of post-translational modifications (PTM). •Product-related and process-related impurities; determination of variants such as truncated and modified forms. •Stability-indicating measurements. •Determination of the secondary structure of peptides and proteins. Application of circular dichroism to the characterization of biopharmaceuticals, the determination of their stability and activity, and quality control. •Basic concepts for planning instrumental Surface Plasmon Resonance assays for affinity and kinetics constant determination of ligand /target protein interaction. •Cases report.
Readings/Bibliography
“Analytical Characterization of Biotherapeutics”
Edited by Jennie R. Lill and Wendy Sandoval
2017. Wiley
Teaching methods
Frontal lessons with slides, videos and scientific articles deposited on virtuale.unibo.it
Assessment methods
The final examination will evaluate the knowledge of the contemporary approaches to assess quality, activity and safety of biopharmaceuticals.
Exam dates, time (and place) will be published on AlmaEsami platformTeaching tools
Slides, videos and scientific articles deposited on virtuale.unibo.it
Office hours
See the website of Vincenza Andrisano