Learning Outcomes:
On completion of this module students should be able to:
1. Identify the importance of downstream processing of biologics in Biomanufacturing
2. Identify the 3 key elements of a DSP strategy for both intracellular and extracellular products, namely capture, intermediate purification and polishing.
3. Understand the principles and associated advantages and disadvantages of the unit operations involved in capture using centrifugation, homogenization and filtration.
4. Understand the principles and associated advantages and disadvantages of using different types of filtration for harvest and purification, namely MF, UF, TFF, NF and DF.
5. Understand the principles and associated advantages and disadvantages of different types chromatography used for intermediate and polishing steps: affinity chromatography, ion-exchange, size-exclusion and hydrophobic interaction chromatography.
6. Understand the importance of viral clearance and inactivation steps.
7. Describe the different types of finished product available (solid or liquid)
8. Design a DSP strategy for a range of biologics including mAbs, ADCs and vaccines.