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Research ArticleProceedings of the 2017 Viral Clearance Symposium

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

Dayue Chen and Glen Bolton
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 462-469; DOI: https://doi.org/10.5731/pdajpst.2018.009100
Dayue Chen
1Eli Lilly, Bioprocess Research & Development, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA; and
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  • For correspondence: CHEN_DAYUE@LILLY.COM
Glen Bolton
2Amgen, 360 Binney Street, Cambridge, MA 02142, USA
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Abstract

Various mammalian cell lines are used as substrates for drug production without safety issues concerning viral contamination. However, viral contamination events in good manufacturing practice (GMP) cell culture processes, while rare, do sometimes occur. When contamination happens, it can result in serious consequences, including supply risk of life-saving drugs and substantial financial loss. To mitigate the potential risk of viral contamination, one approach taken by the industry is to implement preventative measures upstream. High-temperature short-time (HTST) treatment of culture media, at the point of use, was implemented as a virus barrier following murine minute virus (MMV) contamination. In recent years, nanofiltration, commonly used in downstream purification processes, has been evaluated for potential use as a virus barrier alternative to HTST. Several companies shared their data and experience in evaluating nanofiltration for viral barrier purpose upstream in Session 1, Part 2: Virus Barrier. These presentations are summarized below.

LAY ABSTRACT: Viral contamination events in GMP cell culture processes, while rare, do sometimes occur. When contamination happens, it can result in serious consequences, including supply risk of life-saving drugs and substantial financial loss. To mitigate the potential risk of viral contamination, one approach taken by the industry is to implement preventative measures upstream. Several companies shared their data and experience in evaluating virus-retentive filtration for viral barrier purpose upstream.

  • Upstream processing
  • Mammalian cell line
  • Virus barrier filtration
  • High-temperature short-time treatment
  • Viral contamination risk
  • © PDA, Inc. 2018
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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 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
Dayue Chen, Glen Bolton
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 462-469; DOI: 10.5731/pdajpst.2018.009100

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Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
Dayue Chen, Glen Bolton
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 462-469; DOI: 10.5731/pdajpst.2018.009100
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  • Article
    • Abstract
    • Session Overview and Background
    • News on Virus Filtration as Upstream Barrier
    • Andreas Wieser and Thomas R. Kreil, Global Pathogen Safety
    • Exploration of Viral Filtration for Two Decades
    • Shengjiang Shawn Liu, Pathogen Safety of Biological Development, Bayer Pharmaceuticals
    • Demonstration of Viral Clearance for Viral Filtration of Media
    • Glen Bolton, Scientific Director, Amgen
    • Risk Analysis for Implementation of Media Virus Barrier Filter
    • Eva Gefroh and Fernando Garcia, Just Biotherapeutics
    • Effect of Media Concentrates on Virus Barrier Filter Sizing
    • Eva Gefroh, Megan McClure, and Rebecca McCoy, Just Biotherapeutics
    • Summary
    • Conflict of Interest Declaration
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More in this TOC Section

Proceedings of the 2017 Viral Clearance Symposium

  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
  • Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
Show more Proceedings of the 2017 Viral Clearance Symposium

Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
  • Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation
Show more Conference Proceeding

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Keywords

  • Upstream processing
  • Mammalian cell line
  • Virus barrier filtration
  • High-temperature short-time treatment
  • Viral contamination risk

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