Learning outcomes

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

Goals

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.

Content

  1. Introduction
  2. Pre-manufacturing activities: generating and banking the cell line: how to choose an expression vector and an expression system, generation of a cell bank
  3. Upstream manufacturing of biologics: scale up process
  4. Downstream manufacturing of biologics: purification strategies
  5. Characterization and stability of biologics
  6. Immunogenicity assessment of biologics
  7. Study Case: Contamination of Rotavirus Vaccines by Porcine Circovirus

Exercices

Bacterial production of human insulin. Quality control will be performed using western blot.

Assessment method

Oral exam: /15

Practicals: a final report is graded on 5

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, or because of the health situation related to the coronavirus.

Sources, references and any support material

PowerPoint presentations, textbook of practicals, research and review articles.

Language of instruction

Français