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90912 - Analytical Challenges in the Biopharmaceutical Field

Academic Year 2021/2022

                
                        Docente:
                        Manuela Bartolini
                    
                        Credits:
                        3
                    
                        SSD:
                        CHIM/08
                    
                        Language:
                        English
                    
                        Teaching Mode:
                        Traditional lectures
                        
                            Campus:
                            Bologna
                        
                            Corso:
                            Second cycle degree programme (LM) in
                            Pharmaceutical Biotechnology (cod. 9068)

                            Teaching resources on Virtuale

Learning outcomes

At the end of the course the student: - has knowledge of the analytical approaches used for the characterization of biopharmaceutical products, and of the methodologies used for the assessment of safety; - knows the basics on the critical aspects for the quality control of biopharmaceutical products; - understands the problems related to the physico-chemical characterization of recombinant biological products; - has the knowledge to adequately address the problems related to quality, biosafety and microheterogeneity of biological and biothecnological products.

Course contents

- Main issues related to initial and complete characterization of biopharmaceuticals, especially peptides, proteins, antibodies and antibody-drug conjugates.

- Levels of complexity: how to analytically face them?

- Modern spectrometric and instrumental methods for characterizing protein biotherapeutics.

- Current MS-based approaches; Hyphenated analytical techniques and their application in the analysis of peptides and proteins.

- Structural characterization of intact biopharmaceuticals; assessment of PTM.- Product-related and process-related impurities; determination of variants such as truncated and modified forms.- Stability-indicating measurements.

- 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.

- Basic concepts for planning biological assays as for regulatory requirements.

- Case report.

Readings/Bibliography

Lecture slides and review articles

Teaching methods

Lectures and discussion of case reports

Assessment methods

The final examination will evaluate the knowledge of the contemporary approaches to assess quality and safety of biopharmaceuticals.

Teaching tools

Video projector, PC. Educational material available on IOL – Insegnamenti online

Office hours

See the website of Manuela Bartolini

SDGs

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.