Senior Product Manager- Biologics Phenomenex Torrance, California
Reversed-phase liquid chromatography (RPLC) and ultrahigh-pressure liquid chromatography (UHPLC) are common approaches for both characterization and purity analysis of recombinant protein therapeutics such as monoclonal antibodies (mAbs). Intact reversed-phase LC methods are high resolution, capable of separation of hydrophobic variants such as clipping and deamidation. Additionally, intact RPLC methods are relatively quick and capable of being platformed, allowing for method implementation early in development.
However, method parameters for intact reversed-phase LC development are often undefined. Further, with the numerous approaches in generating subunits for mAbs, understanding which parameters to adjust and when can simplify what can be an overly complex design of experiment.
In this discussion, we explore experimental design space for purity analysis of intact proteins. We investigate the use of wide pore core-shell particles, and the critical role they play in gradient slope. Finally, we assess best practices in developing a robust and transferable method to support biotherapeutics development.
Learn different approaches to mAb subunit analysis, and RPLC method development parameters to consider for each
Learn how gradient slope and temperature play critical roles in RPLC method robustness
Learn column selection criteria for intact reversed-phase LC methods