42889 - Analysis of Biotechnological Drugs

Academic Year 2007/2008

  • Docente: Carlo Bertucci
  • Credits: 2
  • SSD: CHIM/08
  • Language: Italian
  • Teaching Mode: Traditional lectures
  • Campus: Bologna
  • Corso: First cycle degree programme (L) in Biotechnologies (cod. 0090)

Learning outcomes

The course concerns with the science and application of modern techniques for the analysis of pharmaceutical products. In particular the course is concerned with the chemical and stereichemical characterization of both small molecule and biological-based medicines.

Course contents

Selection and development of analytical methods for oligopeptides and proteins. Quality control of biotechnology drugs: qualitative analysis and quantitative assay. Stereochemical characterization of chiral drugs: enantiomeric excess determination by enantioselective HPLC and capillary electrophoresis. Polarized light spectroscopy, optical rotation and circular dichroism (CD): determination of the absolute configuration of enantiomeric fractions; secondary structure determination of peptides and proteins. High Performance Affinity Liquid Chromatography (HPALC). Immobilization of receptors, enzymes and plasma proteins in the characterization of new compounds for their activity and their distribution parameters. Displacement chromatography: reversible and covalent modification of the protein. Hyphenated techniques: HPLC-DAD, HPLC-MS, HPLC-CD and their applications to peptide and protein analysis. Chemical and stereochemical stability of biotechnology drugs.

Readings/Bibliography

1). I.W.Wainer, Drug Stereochemistry, Analytical Methods and Pharmacology, M.Dekker, 1993. 2). G.W.Ewing, Analytical Instrumentation Handbook, M.Dekker, 1997. 3). V.Cavrini, V.Andrisano, Analisi Farmaceutica, Metodi di riconoscimento e di separazione, Esculapio, 2004. 4). Lecture slides and specific articles and reviews.

Teaching methods

Lectures.

Assessment methods

This course, together with "Pharmaceutical Chemistry" and "Lab-based Course on Biotechnological Drugs Analysis ", constitutes the integrated course (C.I.) "CHEMISTRY AND ANALYSIS OF BIOTECHNOLOGICAL DRUGS". The final exam, related to the entire C.I., is oral.

Teaching tools

Personal computer and video-projector.

Office hours

See the website of Carlo Bertucci