RT Journal Article
SR Electronic
T1 Retrospective evaluation of cycled resin in viral clearance studies - A multiple company collaboration
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2018.009605
DO 10.5731/pdajpst.2018.009605
A1 Mattila, John
A1 Curtis, Sherrie
A1 Webb-Vargas, Yenny
A1 Wilson, Eileen
A1 Galperina, Olga
A1 Roush, David
A1 Tobler, Scott
A1 Stanley, Bradford
A1 Clark, Mike
A1 Weaver, Justin
A1 Pike, Jeremy
A1 Yu, Deqiang
A1 Li, Xinfang
A1 Flicker, Andreas
A1 Kindermann, Johanna
A1 Schuelke, Norbert
A1 Whitcombe, Richard
A1 Bennett, Louise
YR 2019
UL http://journal.pda.org/content/early/2019/05/15/pdajpst.2018.009605.abstract
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.