Theoretical elements include:
- cell metabolism relevant to culture processes
- cell culture operations in bioreactors
- process development and manufacturing of advanced biologics, including glycoproteins such as monoclonal antibodies, cells for cell therapy and viral vectors for gene therapy
- process scale-up for industrial production
- expression systems, cell lines and vectors/plasmids
- patient safety and regulatory requirements
- analytical methods for characterizing biologics
- process flow charts for manufacturing
Practical elements include:
- design of culture process for production of monoclonal antibodies with simulation software
- culture of suspension cells in shake flasks, including monitoring of metabolic parameters
- culture of adherent stem cells in culture flasks
- small-scale culture in stirred bioreactors
- case studies on, for example, the production of viral vectors or cell products, including project management