PT  - JOURNAL ARTICLE
AU  - Mattila, John
AU  - Curtis, Sherrie
AU  - Webb-Vargas, Yenny
AU  - Wilson, Eileen
AU  - Galperina, Olga
AU  - Roush, David
AU  - Tobler, Scott
AU  - Stanley, Bradford
AU  - Clark, Mike
AU  - Weaver, Justin
AU  - Pike, Jeremy
AU  - Yu, Deqiang
AU  - Li, Xinfang
AU  - Flicker, Andreas
AU  - Kindermann, Johanna
AU  - Schuelke, Norbert
AU  - Whitcombe, Richard
AU  - Bennett, Louise
TI  - Retrospective evaluation of cycled resin in viral clearance studies - A multiple company collaboration
AID  - 10.5731/pdajpst.2018.009605
DP  - 2019 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2018.009605
4099  - http://journal.pda.org/content/early/2019/05/15/pdajpst.2018.009605.short
4100  - http://journal.pda.org/content/early/2019/05/15/pdajpst.2018.009605.full
AB  - The BioPhorum Development Group Viral Clearance Workstream performed a collaborative retrospective analysis to evaluate packed bed chromatographic resin performance after repeated cycling for two commonly used chromatography steps in biopharmaceutical manufacturing: Protein A and anion exchange. Key variables evaluated in the assessment included virus type, resin type, number of reuse cycles, and virus challenge. In this retrospective analysis of viral clearance data on naïve versus cycled resin, powered by the availability of decade’s worth of accumulated industry data, clearance capability is not negatively impacted by resin cycling. This finding is consistent with publications showing that surrogates for viral clearance capabilities could be employed in lieu of testing of viral clearance of cycled resins for Protein A and anion exchange chromatography. The rigorous analysis of the retrospective data supports the view that viral clearance studies for cycled resins are not necessary, provided that appropriate cleaning methods are applied during repeated use of chromatography columns.