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Research ArticleConference Proceeding

Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration

David Roush and Junfen Ma
PDA Journal of Pharmaceutical Science and Technology September 2016, 70 (5) 417-427; DOI: https://doi.org/10.5731/pdajpst.2016.006916
David Roush
1Distinguished Scientist, Merck, Sharp, and Dohme Vaccines and Biologics, 2015 Galloping Hill Road, Mailstop K15-2-H206, Kenilworth, New Jersey 07033; (908) 740-3204; ; and
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  • For correspondence: david_roush@merck.com david_roush@merck.com
Junfen Ma
2Principal Scientist, Amgen, 360 Binney Street, Cambridge MA 02142; ; (617) 444-5664
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  • For correspondence: junfenm@amgen.com
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Article Information

vol. 70 no. 5 417-427
DOI 
https://doi.org/10.5731/pdajpst.2016.006916
PubMed 
27516492

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 3, 2016.

Article Versions

  • previous version (August 11, 2016 - 05:59).
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Copyright & Usage 
© PDA, Inc. 2016

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Cited By...

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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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Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration
David Roush, Junfen Ma
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 417-427; DOI: 10.5731/pdajpst.2016.006916

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Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration
David Roush, Junfen Ma
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 417-427; DOI: 10.5731/pdajpst.2016.006916
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  • Article
    • Background
    • Session Overview
    • Investigation of Low Viral Filter Throughput in a mAb Process (Saravanamoorthy Rajendran, Bianca Olson, Ryan Tedstone, Anne Kantardjieff, and Rachael Alford; Alexion Pharmaceuticals)
    • Virus Filtration and Flow Rate Variation (Thomas R. Kreil and Andreas Wieser; Global Pathogen Safety, Baxalta, Vienna, Austria)
    • Effects of Low Pressure or Depressurization on Parvovirus Removal during Viral Filtration (Sean O'Donnell; Eli Lilly, Indianapolis, IN)
    • Pressure Interruptions in Manufacturing—Tempest in a Teapot? (Konstantin Zoeller; Novartis Pharma AG, Biologics Process R&D, Early Phase Development, Basel, Switzerland)
    • Evaluation of Virus-Retentive Filtration as an Effective Virus Removal Step: Modeling and Outlier Analysis (Valerie Cusick, John Mattila; Regeneron)
    • Key Conclusions and Next Steps
    • References
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Cited By...

  • Analysis of Virus Clearance for Biotechnology Manufacturing Processes from Early to Late Phase Development
  • Proceedings of the 2019 Viral Clearance Symposium, Session 6: Virus-Retentive Filtration
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More in this TOC Section

  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
Show more Conference Proceeding

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