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Research ArticleProceedings of the 2017 Viral Clearance Symposium

Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing

Glen Bolton and Dayue Chen
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 455-460; DOI: https://doi.org/10.5731/pdajpst.2018.009092
Glen Bolton
1Amgen, 360 Binney Street, Cambridge, MA 02142, USA; and
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  • For correspondence: gbolton@amgen.com
Dayue Chen
2Eli Lilly, Bioprocess Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
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Reference

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    1. Brorson K.,
    2. et al
    . Impact of cell culture process changes on endogenous retrovirus expression. Biotechnol. Bioeng. 2002, 80 (3), 257–267.
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    1. Besselsen D.G.,
    2. et al
    . Identification of novel murine parvovirus strains by epidemiological analysis of naturally infected mice. J. Gen. Virol. 2006, 87 (6), 1543–1556.
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  3. 3.↵
    1. Berting A.,
    2. Farcet M.R.,
    3. Kreil T.R.
    Virus susceptibility of Chinese hamster ovary (CHO) cells and detection of viral contaminations by adventitious agent testing. Biotechnol. Bioeng. 2010, 106 (4), 598–607.
    OpenUrl
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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 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
Glen Bolton, Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 455-460; DOI: 10.5731/pdajpst.2018.009092

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Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
Glen Bolton, Dayue Chen
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 455-460; DOI: 10.5731/pdajpst.2018.009092
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  • Article
    • Abstract
    • Session Background and Overview
    • Participant Contributions
    • An Innovative NGS Approach for the Specific Detection of Replicative Viruses in Cell Substrate
    • Detection of Retrovirus in a Perfusion Bioreactor Process
    • Use of a “Generic” RVLP Value in Determining the Retroviral Safety Margin
    • Detection of MMV, or Not
    • Conflict of Interest Declaration
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Keywords

  • Retrovirus-like particles
  • Upstream processing
  • Risk mitigation
  • Next-generation sequencing
  • Virus strains
  • Polymerase chain reaction

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