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 are presented in this webcast. 

 Key topics covered:

  • Understanding the interaction(s) between a model virus and chromatography resins
  • Evaluating the effect of critical process parameters
  • Assessing the design space and optimal process condition
  • Using a pragmatic strategy to ensure viral safety in downstream processing

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