The main objective of the course is to provide the student with: Knowledge of the most commonly used analytical methods for the characterization of therapeutic proteins. Knowledge of the basic principles of different analytical techniques with particular focus on chromatographic techniques.
Course Prerequisites
Basic knowledge of the main spectroscopic techniques (UV-Vis, DC). Fundamentals of chromatography, mass spectrometry and NMR.
Teaching Methods
The course is organized in lectures carried out with PowerPoint presentations and lessons with experiences (5CFU) 1CFU: lab esperience (data treatment)
Assessment Methods
The exam consists of a test at the end of the lessons. The exam will be written and oral, a scientific article will be discussed (50% of the vote) and 2-3 multiple choice questions will be asked on the analytical techniques addressed in the course (50% of the vote). During the oral exam, the critical ability on the course contents and the achievement of the training objectives will be assessed.
Texts
Scientific articles and material reworked by the teacher
Contents
Introduction to biotechnological drugs and Critical Quality Attributes (CQA). Separative methods (reversed phase, hydrophobic interaction, hydrophilic interaction, ion exchange and affinity chromatography) Methods based on mass spectrometry Structural characterization, based on CQA, of therapeutic proteins and monoclonal antibodies: Sample preparation for the study of peptide maps. Sample preparation for glycosylation profiling, Study of post-translational modifications (PTM). Conformational integrity, higher order structures using biophysical techniques.
Impurities: qualitative and quantitative analysis of impurities relating to the product: determination of variants such as truncated forms, modified forms and aggregates (soluble and insoluble).
