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Research ArticleResearch

Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration

John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe and Louise Bennett
PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 470-486; DOI: https://doi.org/10.5731/pdajpst.2018.009605
John Mattila
1Regeneron Pharmaceuticals Inc., Tarrytown, NY;
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Sherrie Curtis
2Genentech, Inc., South San Francisco, CA;
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Yenny Webb-Vargas
2Genentech, Inc., South San Francisco, CA;
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Eileen Wilson
3GlaxoSmithKline plc, King of Prussia, PA;
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Olga Galperina
4GlaxoSmithKline plc, Rockville, MD;
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David Roush
5Merck & Co., Inc., Kenilworth, NJ, USA;
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Scott Tobler
5Merck & Co., Inc., Kenilworth, NJ, USA;
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Bradford Stanley
6Biogen, Research Triangle Park, NC;
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Mike Clark
7AbbVie Bioresearch Center, Worcester, MA;
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Justin Weaver
8Alexion Pharmaceuticals, Inc. Boston, MA;
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Jeremy Pike
8Alexion Pharmaceuticals, Inc. Boston, MA;
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Deqiang Yu
9Bristol-Myers Squibb, Devens MA;
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Xinfang Li
10ImmunoGen, Inc. Waltham, MA;
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Andreas Flicker
11Shire plc, Lexington, MA;
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Johanna Kindermann
11Shire plc, Lexington, MA;
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Norbert Schuelke
12Takeda Pharmaceuticals International Co., Cambridge, MA;
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Richard Whitcombe
13UCB, Brussels, Belgium; and
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Louise Bennett
14BioPhorum Operations Group, London, U.K.
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  • For correspondence: bennettl@biophorum.com
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Abstract

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 a decade’s worth of accumulated industry data, clearance capability was 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 the 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 the chromatography columns.

LAY ABSTRACT: The manufacturing processes for biopharmaceutical products often include reusable chromatographic resins that remove process- and product-related impurities as well as potential contaminating viruses. Typically, chromatography resin is “cycled” through repeated steps of resin conditioning, product purification, and resin cleaning. The cycling approach has been evaluated in both small- and full-scale studies that show the performance parameters are maintained. The ability to remove virus is demonstrated separately in a focused small-scale virus-spiking study that is resource-intensive and costly. This paper is a retrospective review of industry data comparing virus removal by naïve and repeatedly cycled resins that summarizes the viral clearance impact of re-using protein A and anion exchange chromatography resins. The key variables evaluated in the assessment included virus type, resin type, number of cycles, and virus challenge. In this retrospective analysis, it was found that the viral clearance capability is not negatively impacted by resin cycling. This finding is consistent with other publications and supports the view that viral clearance studies for cycled resins are not necessary if appropriate cleaning methods are applied during the repeated use of the chromatography columns.

Abbreviations: AAV-2, Adeno-associated virus; A-MuLV, Amphotropic murine leukemia virus; AEX, Anion-exchange chromatography; B/E, Bind and elute; BVDV, Bovine viral diarrhea virus; C.P.G., Controlled pore glass; DEAE, Diethylaminoethanol; EMCV, Encephalomyocarditis virus; FT, Flow through; HAV, Hepatitis A virus; HSV-1, Herpes simplex virus type 1; LOD, Limit of detection; LOQ, Limit of quantification; LRF, Log10 reduction factor; mAb, Monoclonal antibody; MVM, Minute virus of mice; NaOH, Sodium hydroxide; PA, Protein A; PPV, Porcine parvovirus; QA, Quaternary amine; QP, Quaternized polyethyleneimine; qPCR, Quantitative polymerase chain reaction; Reo3, Reovirus type 3; SuHV-1, Suid herpesvirus; SV40, Simian virus 40; X-MuLV, Xenotropic murine leukemia virus

  • Viral clearance
  • Packed bed chromatography
  • Resin reuse
  • Protein A
  • Anion exchange
  • © PDA, Inc. 2019
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PDA Journal of Pharmaceutical Science and Technology: 73 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
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Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration
John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe, Louise Bennett
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 470-486; DOI: 10.5731/pdajpst.2018.009605

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Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration
John Mattila, Sherrie Curtis, Yenny Webb-Vargas, Eileen Wilson, Olga Galperina, David Roush, Scott Tobler, Bradford Stanley, Mike Clark, Justin Weaver, Jeremy Pike, Deqiang Yu, Xinfang Li, Andreas Flicker, Johanna Kindermann, Norbert Schuelke, Richard Whitcombe, Louise Bennett
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 470-486; DOI: 10.5731/pdajpst.2018.009605
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Keywords

  • Viral clearance
  • Packed bed chromatography
  • Resin reuse
  • Protein A
  • Anion exchange

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