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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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Abstract

Monoclonal antibodies (mAbs) are typically produced using mammalian cell lines, which are known to express endogenous retrovirus-like particles (RVLPs) and also have the potential to be infected by viruses. This session focused on the detection and measurement of these viruses and RVLPs. In the first session, it was shown that next-generation sequencing (NGS) can detect, with a similar sensitivity as polymerase chain reaction (PCR), viruses in cells without a priori knowledge of the specific virus and more importantly that a specific NGS approach can decipher whether the signal corresponds to a replicating virus. The second session provided data showing that the PCR assay for detection of ecotropic recombinant virus (ERV) genome is an alternative to quantification by transmission electron microscopy (qTEM) for quantification of RVLP. In addition, the potential use of a harvest filter for RVLP retention in a perfusion process was discussed. In the third session, RVLP data from 67 different Pfizer programs spanning different conditions were presented. No single factor had a significant impact on the level of RVLPs. It was suggested that a “generic” or “worst-case” RVLP value, derived from a well-characterized platform cell culture process, could be used with confidence to determine a conservative retroviral safety margin for platform processes. In the fourth session, the sensitivity of several cell culture– and PCR-based assays for detection of different MMV strains using several production cells was discussed. It was found that molecular assays were generally superior in the breadth of detection with equivalent sensitivity.

LAY ABSTRACT: This session focused on the detection and measurement of viruses and virus-like particles in cell lines and manufacturing processes used for production of therapeutic proteins.

  • Retrovirus-like particles
  • Upstream processing
  • Risk mitigation
  • Next-generation sequencing
  • virus strains
  • Polymerase chain reaction
  • © 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 1.1: 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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  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
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Keywords

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

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