437386 Impact of virus filtration load handling on virus filter performance

Monday, November 9, 2015: 3:35 PM
155F (Salt Palace Convention Center)
Hong Li1, Darshini Shah1, Kathleen McLaughlin1, Michael Iammarino2, David Roush3 and Nihal Tugcu4, (1)Protein Purification Development, Merck & Co., Union, NJ, (2)BioPurification Development, Merck & Co., Rahway, NJ, (3)MBV Process Development, Merck & Co., Rahway, NJ, (4)Process Development and Engineering, Merck & Co., Kenilworth, NJ

Virus-retentive filtration (VF) is routinely incorporated into monoclonal antibody downstream purification processes as a dedicated virus removal unit operation to provide robust and reliable virus clearance capacity. VF is applicable to a wide range of viruses since the primary mechanism is size based. Performing experiments at bench scale introduces the possibilities that the feed and material handling used for validation studies are not representative of those at manufacturing scale. In this work, investigations into the filter flux decay during a small scale mock filtration run before viral clearance study were conducted. A comparison of the performance of two filter designs was completed, along with biochemical and biophysical characterization of the feed streams. It was determined that both virus filter load handling (freezing and thawing) and preparation (pre-filtration) impacted virus filtration performance without and with virus spiking.

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