- Docente: Vincenza Andrisano
- Credits: 3
- SSD: CHIM/08
- Language: English
- Teaching Mode: Traditional lectures
- Campus: Rimini
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Corso:
Single cycle degree programme (LMCU) in
Pharmacy (cod. 5987)
Also valid for Single cycle degree programme (LMCU) in Pharmacy (cod. 9078)
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from Oct 02, 2023 to Nov 14, 2023
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 for the characterization of antibodies and protein biotechnological drugs: how to analytically face them?
Spectrometric and instrumental methods for characterizing protein biotherapeutics (molecular mass, peptide composition, peptide sequence, primary, secondary and tertiary and quaternary strucure, PTM) assessment of PTM.Top down and bottom up approach by mass spectrometry
HPLC size exclusion chromatography, reversed phase systems, ion exchange chromatography and other chromatographic approach for biosimilarity assessment. Structural characterization of intact biopharmaceuticals and biosimilarity.
Product-related and process-related impurities; determination of variants such as truncated and modified forms.
Surface Plasmon Resonance as a tool to verify binding properties of bimolecular interaction (i.e. antibody-antigen interaction)
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.
Readings/Bibliography
Biological Drug Products-develpoment and strategies
Edited by WEI WANG, MANMOHAN SINGH
2014 Editio. by John Wiley & Sons, Inc.
“Analytical Characterization of Biotherapeutics”
Edited by Jennie R. Lill and Wendy Sandoval
2017. Wiley
Teaching methods
Slides, videos
Assessment methods
Oral exam
Teaching tools
slides and videos
Office hours
See the website of Vincenza Andrisano