Protein and Antibody Downstream Processing
This section covers the series of operations immediately following the cell culture, lysate or refold clarification process. The first of these unit operations is a capture where the product protein is typically bound to an affinity chromatography resin and then recovered by elution with a buffer solution. Once recovered, the protein solution is further purified and concentrated through filtration or additional chromatography steps until the final solution is ready for final fill operations.
The primary goals for successful protein processing are:
- High product purity
- High product quality (or activity)
- Robustness (consistency from batch to batch)
- High product yield
- Controlled bioburden and endotoxin
- Economical
