Process robustness and success requires a thorough understanding of critical process parameters (CPPs), critical material attributes (CMAs), and sometimes interactions between these. Chromatography resin attributes, such as ligand density, can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
This webinar illustrates a cation exchange chromatography process development workflow to assess the effect of ligand density variability on product quality and process performance using a Process Characterization Kit. The workflow described includes:
- Factor screening
- Process design
- Risk assessment
- Process characterization
Watch the webinar now >>