On completion of this module students should be able to:

1. Describe the techniques involved in the generation of cell lines for production and to describe the procedures involved in cell banking and cell characterisation.
2. To describe the types of media formulations available for both small and large scale cell culture
3. Describe the methods and technologies used for large-scale cell culture of mammalian cells for biologic production.
4. Describe the physiological responses of animal cells to environmental conditions in culture vessels, including those arising from nutrient limitation and adverse hydrodynamic effects.
5. To understand and describe the techniques involved in monitoring growth, viability, metabolism and productivity of cells during a bioprocess.
6. Describe the upstream and downstream production of mAbs and ADCs.
7. Describe the production of vaccines in mammalian cells, both live and attenuated.
8.Describe the recent developments involved in production of cell therapies and tissue engineered constructs.

Overview of the production of biologics in mammalian cells
Generation of production cell lines, CHO, NS0
Physical environment, tissue culture flasks and essential equipment, laminar flows and clean rooms
Chemical environment: types of media, SF, CDM, and PFM, water quality
Large scale culture of anchorage dependent and independent cells : cell factories, microcarriers
Growth of cells in STB, CPPs
Measurement of cell viability and growth
Production of mAbs and ADCs in CHO cells: overview of both upstream and downstream processes
Production of Vaccines
Production of cell therapies
Glycoslylation and QbD

Not applicable to this module.

• Group/class feedback, post-assessment

Not yet recorded.