Upon successful completion of this course, students will be able:
to identify and describe the fields of biotechnology.
to choose the proper expression vector and expression system based upon the biologic to be produced
to set up a scale up of the production
to design a purification strategy for the produced biologic
to design an experimental strategy to characterize the biologic as well as its stability
to design an experimental strategy to assess immunogenicity of the produced biologic
This course provides a comprehensive overview of a biologic production from the design of the expression vector to the assessment of immunogenicity of the produced biologic.
Introduction
Pre-manufacturing activities: generating and banking the cell line: how to choose an expression vector and an expression system, generation of a cell bank
Upstream manufacturing of biologics: scale up process
Downstream manufacturing of biologics: purification strategies
Characterization and stability of biologics
Immunogenicity assessment of biologics
Integrated Development of Biologic Drug Delivery Systems
Study Case: Contamination of Rotavirus Vaccines by Porcine Circovirus
Introduction
Pre-manufacturing activities: generating and banking the cell line: how to choose an expression vector and an expression system, generation of a cell bank
Upstream manufacturing of biologics: scale up process
Downstream manufacturing of biologics: purification strategies
Characterization and stability of biologics
Immunogenicity assessment of biologics
Integrated Development of Biologic Drug Delivery Systems
Study Case: Contamination of Rotavirus Vaccines by Porcine Circovirus
Not applicable
Lectures.
Oral exam on the lectures: /20
The exact modalities of the evaluation are likely to be modified during the preparation of the examination schedules, depending on the practical constraints with which the faculty administration may be confronted, or in the event of illness / force majeure / encroachment with an internship.
PowerPoint presentations, textbook of practicals, research and review articles.
| Training | Study programme | Block | Credits | Mandatory |
|---|---|---|---|---|
| Master in Biomedical Sciences | Filière en recherche fondamentale et préclinique | 1 | 3 | Yes |
| Master in Biomedical Sciences | Standard | 1 | 3 | No |
| Master in Biomedical Sciences | Filière en gestion de la recherche clinique | 1 | 3 | No |
| Master in Biochemistry and Molecular and Cell Biology | Finalité approfondie | 1 | 3 | Yes |
| Master in Biochemistry and Molecular and Cell Biology | Finalité spécialisée | 1 | 3 | Yes |