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Research ArticleProceedings of the 2013 Viral Clearance Symposium

Session 2/3: Integrated Viral Clearance Strategy and Case Studies

Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 183-194; DOI: https://doi.org/10.5731/pdajpst.2015.01042
Hannelore Willkommen
Regulatory Affairs & Biological Safety (RBS) Consulting
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  • For correspondence: hannelore.willkommen@gmx.de
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PDA Journal of Pharmaceutical Science and Technology: 69 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
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Session 2/3: Integrated Viral Clearance Strategy and Case Studies
Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 183-194; DOI: 10.5731/pdajpst.2015.01042

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Session 2/3: Integrated Viral Clearance Strategy and Case Studies
Hannelore Willkommen
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 183-194; DOI: 10.5731/pdajpst.2015.01042
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  • Article
    • Background
    • DoE-Based AEX Technology Comparison (George Miesegaes, CDER/FDA) [A larger body of this work has been published recently (1)]
    • Viral Clearance for Vaccine Candidate Using Baculovirus Expression System Focusing On Aex Bind-Elute Chromatography (Adam Kristopeit, Merck, Sharp and Dohme, Inc.)
    • Discussion
    • Quantification of Retrovirus-Like Particle (RVLP) Removal at Manufacturing Scale (Christian H. Bell, Jutta Mayr, Marit Raible, Stefan Hepbildikler, Roche Diagnostics GmbH)
    • Viral Clearance Strategy—General Considerations (Hannelore Willkommen, RBS-Consulting)
    • Opportunities and Challenges of Working with a Human Cell Substrate (Dominick Vacante, Janssen Research & Development, LLC)
    • Risk-Based Justification for Why Master Cell Bank (MCB) and Unprocessed Bulk (UPB) Are Screened by In Vitro Viral (IVV) Testing with Different Assay Durations (Dayue Chen, Eli Lilly)
    • Design of Viral Clearance Study To Support Marketing Authorization (Olga Galperina, GSK)
    • Summary
    • References
  • Figures & Data
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  • References
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More in this TOC Section

Proceedings of the 2013 Viral Clearance Symposium

  • Viral Inactivation: Low pH and Detergent
  • Appendix: Organizers, Participants and Contributors of the 2013 Viral Clearance Symposia
  • Proceedings of the 2013 Viral Clearance Symposium (Princeton, NJ)
Show more Proceedings of the 2013 Viral Clearance Symposium

Conference Proceeding

  • Viral Inactivation: Low pH and Detergent
  • Appendix: Organizers, Participants and Contributors of the 2013 Viral Clearance Symposia
  • Proceedings of the 2013 Viral Clearance Symposium (Princeton, NJ)
Show more Conference Proceeding

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