Considerable resources are spent within the biopharmaceutical industry to perform viral clearance studies, which are conducted for widely used unit operations that are known to have robust and effective retrovirus clearance capability. The collaborative analysis from the members of the BioPhorum Development Group Viral Clearance Working Team considers two common virus reduction steps in biopharmaceutical processes: low-pH viral inactivation and viral filtration. Analysis included eight parameters for viral inactivation and nine for viral filtration. The extensive data set presented in this paper provides the industry with a reference point for establishing robust processes in addition to other protocols available in the literature (e.g., ASTM Std. E2888-12 for low-pH inactivation). In addition, it identifies points of weakness in the existing data set and instructs the design and interpretation of future studies. Included is an abundance of data that would have been difficult to generate individually but collectively will help support modular viral clearance claims.
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Viral clearance: Retrospective evaluation of low-pH viral inactivation and viral filtration data from a multiple company collaboration: PRESENTATIONS AND POSTERS
Mar 2016 | Development Group
Members can download here presentations and posters that complement the paper ‘Retrospective evaluation of cycled resin viral clearance studies – A multiple company collaboration’, and presented at seven conferences between March 2016 and September 2017.