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Research ArticleConference Proceeding

Session 4.1: Case Studies of Application of Generic Claims and QbD for Viral Clearance

Rachel Specht and Meisam Bakhshayeshi
PDA Journal of Pharmaceutical Science and Technology September 2016, 70 (5) 462-469; DOI: https://doi.org/10.5731/pdajpst.2016.006957
Rachel Specht
1Process Virology/Purification Development Department. Genentech, a Member of the Roche Group, 1 DNA Way, MS10, South San Francisco, CA 94080; (650) 467-2372; ; and
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  • For correspondence: specht.rachel@gene.com specht.rachel@gene.com
Meisam Bakhshayeshi
2Senior Engineer, Biogen, 225 Binney Street, Cambridge, MA 02142; (617) 679-3264;
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  • For correspondence: meisam.bakhshayeshi@biogen.com
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References

  1. 1.↵
    Proceedings of the 2009 Viral Clearance Symposium. Karger, 2010.
  2. 2.↵
    1. Stuckey J.,
    2. Strauss D.,
    3. Venkiteshwaran A.,
    4. Gao J.,
    5. Luo W.,
    6. Quertinmont M.,
    7. O'Donnell S.,
    8. Chen D.
    A novel approach to achieving modular retrovirus clearance for a parvovirus filter. Biotechnol. Prog. 2014, 30 (1), 79–85; doi:10.1002/btpr.1820.
    OpenUrlCrossRef
  3. 3.↵
    Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997.
  4. 4.↵
    ASTM Standard E2888. Standard Practice for Inactivation of Rodent Retrovirus by pH, 2012.
  5. 5.↵
    PDA Technical Report No. 41.
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PDA Journal of Pharmaceutical Science and Technology: 70 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 5
September/October 2016
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Session 4.1: Case Studies of Application of Generic Claims and QbD for Viral Clearance
Rachel Specht, Meisam Bakhshayeshi
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 462-469; DOI: 10.5731/pdajpst.2016.006957

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Session 4.1: Case Studies of Application of Generic Claims and QbD for Viral Clearance
Rachel Specht, Meisam Bakhshayeshi
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 462-469; DOI: 10.5731/pdajpst.2016.006957
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  • Article
    • Introduction
    • (1) Implementation of Modular Claims for the Clearance of Xenotropic Murine Leukemia Virus (XMuLV) by Low-pH Inactivation and Virus-Retentive Filtration (Michael Clark, AbbVie Bioresearch Center, Worcester, MA)
    • Low-pH Inactivation
    • Virus-Retentive Filtration
    • (2) The Use of Viresolve Pro in a Modular Viral Clearance Process (Dan LaCasse; Pfizer, Andover, MA)
    • (3) ASTM and the Development of Standards for Virus Removal and/or Inactivation (Bob Steininger)
    • (4) Virus Filtration QbD (Rachel Specht; Genentech, South San Francisco, CA)
    • (5) Viral Safety Considerations in Dual Sourcing of Raw Materials in Downstream Processing (Stefan Hepbildikler; Roche, Penzberg, Germany)
    • Summary
    • References
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More in this TOC Section

  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
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