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Research ArticleProceedings of the 2013 Viral Clearance Symposium

Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration

Qi Chen and Dayue Chen
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 142-153; DOI: https://doi.org/10.5731/pdajpst.2015.01038
Qi Chen
1Genentech, a Member of the Roche Group; Process Virology, 1 DNA Way, Mailstop 10, South San Francisco, CA 94080;
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  • For correspondence: chen.qi@gene.com chen_dayue@lilly.com
Dayue Chen
2Bioproduct Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285
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  • For correspondence: chen.qi@gene.com chen_dayue@lilly.com
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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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Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
Qi Chen, Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 142-153; DOI: 10.5731/pdajpst.2015.01038

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Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
Qi Chen, Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 142-153; DOI: 10.5731/pdajpst.2015.01038
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  • Article
    • Introduction
    • Proposed Operation and Validation of Multiple Viral Filtration Cycles within a Harvest Lot (Eva Gefroh, and Megan McClure; Amgen)
    • Virus-Retentive Filtration (Thomas Kreil; Global Pathogen Safety—Baxter BioScience)
    • Introduction of an Alternate Viral Filter to a Commercial Process and Optimization of Scale-down Filter Capacity (Philippe de Vilmorin; Biogen Idec)
    • Parvovirus Clearance on a Virus-Retentive Filter—Consideration of Log Reduction and Virus Breakthrough in Determining Virus Load Challenge (Eileen Wilson; GlaxoSmithKline)
    • Low Pressure and High Membrane Load Lead to Virus Breakthrough in Virus Removal Filtration of a MAb (Susan Liu; Janssen Research and Development)
    • Effect of pH, Conductivity, Pressure Release on Parvovirus Clearance (Sean O'Donnell, Adith Venkiteshwaran, and Dayue Chen; Eli Lilly and Company)
    • Impact of Using High-Purity Virus Spikes on the Apparent Breakthrough of MMV during Viral-Retentive Filtration Evaluations and Maintaining Virus Retention during Depressurisation Events (James Berrie; Lonza)
    • Prediction of Viral Filtration (VF) Performance of MAbs via Biophysical Analysis (William Rayfield, David Roush, Jason Cheung, Shehab Barakat, and Nihal Tugcu; Merck Research Laboratories)
    • Mechanistic Failure Mode Resolution and Comparison of Parvovirus-Retentive Filters (Daniel LaCasse, Pfizer; and Kurt Brorson, Center for Drug Evaluation and Research, U.S. Food and Drug Administration)
    • Impact of Pressure and Pausing on Virus-Retentive Riltration (John Mattila; Regeneron)
    • Summary
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Cited By...

  • Using Sensitivity Analysis to Simplify the Virus Safety Factor Calculation in the Manufacture of Biopharmaceuticals
  • Proceedings of the 2019 Viral Clearance Symposium, Session 6: Virus-Retentive Filtration
  • Twenty plus Years of Data Demonstrating Virus Filtration as an Effective and Robust Step for Large Virus Removal
  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations--Virus Filtration/Inactivation
  • Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration
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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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