Downstream mAb processing typically employs a harvest step, multiple chromatography steps, multiple process intermediate filtrations and a final ultrafiltration step.  Each unit operation in the process is designed for specific purification goals based on the quality of the incoming feed stream and the desired quality profile of the drug substance.  Advances in upstream processing are generating more productive cell cultures processes.  This is often accompanied with increases in product impurities, such as aggregates, and process related impurities, such as residual host cell proteins (rHCP).  These purification challenges can only be overcome if each unit operation is providing the most robust impurity removal possible.  <br/>The work presented here highlights the efforts to understand how the choice of post viral inactivation filter media impacted overall process impurity clearance which can ultimately lead to a more stable drug substance.  The filter evaluation included 6 filters, from 4 different manufacturers, with 5 unique media types, conducted with 4 different mAbs.  Several performance (loading and yield) and quality attributes (turbidity reduction, aggregate & residual impurity clearance) were compared across the panel of filters tested.  Additionally, each filter was evaluated for its ability to clear impurities related to PS80 degradation.  We observed that tracking rHCP impurity clearance across filters provided a primary means of differentiation and ultimately guided final filter selection.

Depth filter media and post viral inactivation filtration performance

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.