A route to deeper process understanding-Studying resin variability using a Process Characterization
Tobias Söderman, Senior Scientist, BioProcess R&D at Cytiva, Uppsala, Sweden
Process robustness and success requires a thorough understanding of critical process parameters (CPP), critical material attributes (CMA), and sometimes interactions between these. Chromatography resin attributes can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
Ligand density is an important resin attribute that may display interaction with process parameters, such as conductivity and pH.
Resin variability and its potential impact on the process outcome can be studied at various stages in process development. Most commonly, it is addressed in the process characterization study after a suggested process design has been decided upon. This webinar illustrates a cation exchange chromatography process development workflow to assess the potential effect of ligand density variability on product quality and process performance using a Process Characterization Kit. The workflow includes:
- Factor screening
- Process design
- Risk assessment
- Process characterization
Senior Scientist, BioProcess R&D at Cytiva, Uppsala, Sweden Tobias has worked to develop new resin products for the last 20 years. He was involved in the development and launch of Capto S ImpAct, Capto Core 700, and MabSelect PrismA resins, as well as other products. With a background in polymer chemistry, Tobias is able to offer his considerable technical expertise to secure smooth operation of our BioProcess resin production facility