ANALISI DEI FARMACI BIOTECNOLOGICI

The objective of this course is to introduce the basic principles and techniques of modern analytical chemistry necessary for the structural characterization, qualitative-quantitative analysis and optimization of the production processes of biotechnological drugs.
At the end of the course the student: - acquires the basic notions for the structural characterization of biotechnological drugs using spectroscopic and spectrometric techniques; - acquires theoretical knowledge of chromatographic separations and capillary electrophoresis for the analysis of biotechnological drugs; - acquires the strategies for the development of new instrumental methods for the qualitative and quantitative identification of biotechnological drugs in pre-clinical / clinical research and in quality control; - acquires knowledge for sample preparation; - acquires knowledge for the validation of analytical methods according to current guidelines.

EXPECTED RESULTS
Knowledge and understanding: the student will have to acquire the theoretical and practical preparation for the analysis and structural characterization of biotechnological drugs reported in the official pharmacopoeias, using instrumental analytical techniques.
Ability to apply knowledge and understanding: the student must be able to use the knowledge acquired in the field of instrumental analysis to design, develop and validate protocols for the analysis of biotenological drugs in complex matrices.
Autonomy of judgment: The student must be able to interpret the experimental results obtained.
Communication skills: At the end of the course, the student must be able to explain what he has learned using an adequate terminology for a correct scientific presentation regarding the analytical techniques for the characterization of biotenological drugs.
Learning ability: The student must have developed theoretical/practical skills useful to be able to update his knoledge in order to face new analytical problems.

Theoretical classroom lessons (42 hours) with the aid of video projection systems of slides and videos.

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.

Learning assessment may also be carried out on line, should the conditions require it.

Introduction to instrumental analytical methods. Absorption spectroscopies: ultraviolet and visible; fluorescence and phosphorescence; infrared spectroscopy. Mass spectrometry. Nuclear magnetic resonance spectrometry (1H- and 13C-NMR).

Chromatographic techniques. General principles of the chromatographic process and chromatographic parameters. Constant of distribution. Retention time. Capacity factor. Resolution. Selectivity. Efficiency: plate theory; van Deemter equation. Adsorption chromatography, partition chromatography, ion exchange chromatography, ion pair chromatography, molecular exclusion chromatography, affinity chromatography.

Column chromatography, thin layer chromatography (TLC). High-performance liquid chromatography (HPLC): instrumentation. Gas chromatography (GC): instrumentation.

Combined techniques: liquid chromatography and photodiode UV-VIS detector (HPLC-DAD); Liquid chromatography and mass spectrometry (HPLC-MS); Gas chromatography and mass spectrometry (GC-MS).

Capillary electrophoresis (EC): instrumentation, theoretical principles, analytical parameters, techniques (CZE, MEKZ, MEEKC).

Qualitative and quantitative analysis (external standard method, internal standard method). Sample preparation and extraction methods. Classic extraction methods (liquid/liquid and liquid/solid). Extraction with supercritical fluids (SFE). Solid phase extraction (SPE). Preparation of samples from complex biological matrices. Validation of the analytical method: linearity, precision, accuracy, reproducibility, limit of detection (LOD), limit of quantification (LOQ). Development of chromatographic methods for quality control and in pre-clinical and clinical research.

1. R.M. Silverstein, F.X. Webster, Identificazione spettroscopica di composti organici - Ambrosiana Editrice, Milano, 2016
2. V. Cavrini. Principi di Analisi Farmaceutica, terza edizione. Società Editrice Esculapio, Bologna
3. J.F. Holler, S.R. Crouch. Fondamenti di chimica analitica di Skoog e West. EdiSES, III edizione 2015
4. Veronika R. Meyer. Practical High-Performance Liquid Chromatography, 5th Edition. Wiley, New York