The objective of the course is to provide basic knowledge on the most important analytical separative techinques used for the characterization and analysis of drugs produced by biotechnological processes. Students will learn how to study the structure of a complex mocule such as a biological drug, by applying consolidated and innovative analytical techniques, and will be able to select the best analytical approach based on the physico-chemical properties of the drug and the investigation objective. Through journal clubs and scientific paper reading, students will also learn to understand and critically evaluate the scientific literature in the field.
Course Prerequisites
Basic concepts in Chemistry and Biochemistry.
Teaching Methods
The course is taught through frontal lectures. PowerPoint presentations will be used. Journal clubs and scientific paper reading might be used to deepen some aspects.
Assessment Methods
The final grade will be determined by the sum of the following components: - A written test, to be taken in person in a computer room via the Kirotesting platform (maximum score: 20). The test will consist of 2 open-ended questions and 4 closed-ended questions or exercises. - A home assignment on the MS part (maximum score: 10). - Up to 2 points awarded for active participation in class. Students are required to complete the entire course, consisting of this module and the module ‘Analysis and Quality Control of Biotechnological Drugs’, within six exam sessions. After that, the module must be retaken.
Texts
Scientific papers and material reworked by the teacher will be available online on the KIRO page of the course.
Contents
The focus of the course is on the analytical techniques most commonly used for the characterization of biotechnological drugs. The first part focuses on liquid chromatography (LC) for protein and peptide analysis, and covers basics of LC, different chromatographic modes (reverse phase, hydrophilic interaction, hydrophobic interaction and ion exchange), stationary phases and technological advancements. The second part focuses on mass spectrometry (MS), and covers basics of MS, ion sources (ESI and MALDI), mass analysers and MS-based approaches for protein characterization (from amino acid sequence to 3D structrure). The acquired knowledge on LC and MS will be exploited to discuss the investigation of the critical quality attributes (CQAs) of biotechnological drugs and to critical evaluate scientific papers.
