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OtherResearch

Twenty Plus Years of Data Demonstrating Virus Filtration as an Effective and Robust Step for Large Virus Removal

Brad Stanley, Veronica Holmes, Richard Manzari, Cara Romanowski, Anja Tessarz, Horst Ruppach and John Schreffler
PDA Journal of Pharmaceutical Science and Technology May 2021, pdajpst.2020.012591; DOI: https://doi.org/10.5731/pdajpst.2020.012591
Brad Stanley
1 Biogen, Inc., Process Biochemistry, 5000 Davis Drive, Research Triangle Park, NC;
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  • For correspondence: brad.stanley@biogen.com
Veronica Holmes
2 Janssen R&D LLC, Biotherapeutic Development API, 200 Great Valley Parkway, Malvern, PA;
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  • For correspondence: vholmes2@its.jnj.com
Richard Manzari
3 WuXi Advanced Therapies, Viral Clearance, 4751 League Island Boulevard, Philadelphia, PA;
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  • For correspondence: richard.manzari@wuxiapptec.com
Cara Romanowski
3 WuXi Advanced Therapies, Viral Clearance, 4751 League Island Boulevard, Philadelphia, PA;
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  • For correspondence: cara.romanowski@wuxiapptec.com
Anja Tessarz
4 Charles River Laboratories GmbH Biologics Testing Gottfried-Hagen Strasse 20 51105 Koln Germany;
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  • For correspondence: anja.tessarz@crl.com
Horst Ruppach
5 Charles River Laboratories GmbH Biologics Testing Gottfried-Hagen Strasse 20 51105 Koln Germany
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John Schreffler
2 Janssen R&D LLC, Biotherapeutic Development API, 200 Great Valley Parkway, Malvern, PA;
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Abstract

Virus filtration has been demonstrated to be an effective and robust dedicated viral clearance step that is used in biopharmaceutical manufacturing processes. Here we present virus filtration data from a multi-company collaboration with data compiled from WuXi Advanced Therapies′ and Charles River Laboratories′ internal viral clearance databases spanning more than 25 years. The data were sorted by virus removal and type and then further subdivided into murine leukemia virus only, pseudorabies virus only, and reovirus type 3 only categories to allow for analyses of viral clearance results. A total of 2311 virus filtrations were analyzed, comprised of 1516 murine leukemia virus, 385 pseudorabies virus, and 410 reovirus type 3 virus filtrations. These data provide clear evidence that will help supplement both internal and industry-wide initiatives focused on using prior knowledge for the creation of modular claims for small virus retentive filters and allow better allocations of resources typically spent on potentially unnecessary studies.

  • Murine Leukemia Virus (MuLV)
  • large virus retentive filter
  • modular viral clearance
  • small virus retentive filter
  • viral clearance
  • viral filtration
  • Received December 2, 2020.
  • Accepted May 10, 2021.
  • Copyright © 2021, Parenteral Drug Association

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PDA Journal of Pharmaceutical Science and Technology: 76 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 3
May/June 2022
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Twenty Plus Years of Data Demonstrating Virus Filtration as an Effective and Robust Step for Large Virus Removal
Brad Stanley, Veronica Holmes, Richard Manzari, Cara Romanowski, Anja Tessarz, Horst Ruppach, John Schreffler
PDA Journal of Pharmaceutical Science and Technology May 2021, pdajpst.2020.012591; DOI: 10.5731/pdajpst.2020.012591

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Twenty Plus Years of Data Demonstrating Virus Filtration as an Effective and Robust Step for Large Virus Removal
Brad Stanley, Veronica Holmes, Richard Manzari, Cara Romanowski, Anja Tessarz, Horst Ruppach, John Schreffler
PDA Journal of Pharmaceutical Science and Technology May 2021, pdajpst.2020.012591; DOI: 10.5731/pdajpst.2020.012591
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Keywords

  • Murine leukemia virus (MuLV)
  • Large virus retentive filter
  • Modular viral clearance
  • Small virus retentive filter
  • Viral clearance
  • viral filtration

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