Assessing Viral Clearance in Early Phase Process Development

This webcast features: William H. Rushton, Process Chromatography Support Scientist, Bio-Rad Laboratories

Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development.

A design of experiments (DOE) approach was utilized in this case study to investigate the effect of buffer pH and conductivity on the removal of various product- and process-related impurities by an anion-exchange (AEX) mixed-mode chromatography resin. Results from these studies have offered insights on the interactions between the resin and minute virus of mice (MVM) and xenotropic murine leukemia virus (XMuLV). A ceramic hydroxyapatite medium and a high-resolution cation-exchange (CEX) resin were also evaluated under typical conditions and will be presented in this webcast.

Overview:

    • Understand the interaction(s) between a model virus and chromatography resins
    • Evaluate the effect of critical process parameters
    • Assess the design space and optimal process condition
    • Use a pragmatic strategy to ensure viral safety in downstream processing

Just fill out the form below to watch the recorded webcast now.

Leave a Reply