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Research ArticleProceedings of the 2017 Viral Clearance Symposium

Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation

Thomas R. Kreil and David Roush
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 470-478; DOI: https://doi.org/10.5731/pdajpst.2018.009118
Thomas R. Kreil
1Department of Virology, Global Pathogen Safety, Shire; A-1220 Vienna, Austria; and
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  • For correspondence: thomas.kreil@shire.com
David Roush
2Bioprocess Development/Biologics Research, MSD, Kenilworth, NJ, USA
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Article Information

vol. 72 no. 5 470-478
DOI 
https://doi.org/10.5731/pdajpst.2018.009118
PubMed 
30030356

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 6, 2018.

Article Versions

  • previous version (July 20, 2018 - 14:19).
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Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Thomas R. Kreil1,* and
  2. David Roush2
  1. 1Department of Virology, Global Pathogen Safety, Shire; A-1220 Vienna, Austria; and
  2. 2Bioprocess Development/Biologics Research, MSD, Kenilworth, NJ, USA
  1. ↵* Corresponding Author: Global Pathogen Safety, Shire; A-1220 Vienna, Austria; e-mail: thomas.kreil{at}shire.com
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PDA Journal of Pharmaceutical Science and Technology: 72 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 5
September/October 2018
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Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
Thomas R. Kreil, David Roush
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 470-478; DOI: 10.5731/pdajpst.2018.009118

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Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
Thomas R. Kreil, David Roush
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 470-478; DOI: 10.5731/pdajpst.2018.009118
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  • Article
    • Abstract
    • Introduction
    • Optimization of Viral Filtration Process Conditions to Enable a Representative Scale-Down Model
    • Virus Filtration—challenges for Scale-Down
    • Effects of Pressure Source on Virus Breakthrough During Viral Filtration
    • Multiple, Deliberate Interruptions of a Virus Removal Filtration Process—Impact on Virus Retention and Throughput
    • Validating an Alternative Virus Reduction Filter for a Commercial Product
    • Investigational Study on the Robustness of the 20-nm Nanofiltration Step Performed According to the Doe Methodology
    • What to Do When the Virus Filtration Cannot Be Validated as Usual?
    • Establishing a Generic Claim for Lauryldimethylamine N-oxide Detergent Inactivation
    • Virus Inactivation at Low pH: Impact of Buffer Composition, pH Value, and Protein Concentration on the Inactivation of Different Retroviruses
    • Conclusion
    • Conflict of Interest Declaration
    • Reference
  • Figures & Data
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  • Info & Metrics
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Cited By...

  • Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
  • Proceedings of the 2019 Viral Clearance Symposium, Session 6: Virus-Retentive Filtration
  • Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
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More in this TOC Section

Proceedings of the 2017 Viral Clearance Symposium

  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations
  • Proceedings of the 2017 Viral Clearance Symposium—
Show more Proceedings of the 2017 Viral Clearance Symposium

Conference Proceeding

  • 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
Show more Conference Proceeding

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Keywords

  • Downstream processing
  • Virus-Retentive Filtration
  • Virus inactivation
  • Low pH treatment
  • Detergent treatment

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