Biotechnology : Principles and Scale-up [MSBMM107]

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

Objectives

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

Exercises description

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