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Research ArticleConference Proceedings

Proceedings of the 2019 Viral Clearance Symposium, Session 8. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments and Actions

Glen Bolton
PDA Journal of Pharmaceutical Science and Technology July 2022, 76 (4) 362-367; DOI: https://doi.org/10.5731/pdajpst.2021.012684
Glen Bolton
Amgen, 360 Binney Street, Cambridge MA 02142
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Abstract

This report provides a high-level summary of the key outcomes and gaps based on the research presented at the 2019 Viral Clearance Symposium and identifies new areas for future study and improvements. The 2019 conference structure extended the framework from the preceding conferences, focusing on the key gaps and associated developments and including the additional focus areas of facility risk mitigation, modular viral clearance claims, depth filter viral clearance, retrospective analysis of viral clearance and continuous processing, quantitation and analysis of viral clearance, viral inactivation by detergents and low pH, viral filtration mechanisms, viral filtration of media, viral detection by next-generation sequencing, and ways to improve the efficiency of the overall adventitious agent strategy.

  • Viral clearance
  • Viral safety
  • Viral Clearance Symposium
  • Upstream processing
  • Downstream processing
  • Resin lifetime
  • Facility risk mitigation
  • Submission
  • Strategy
  • Next-generation sequencing
  • Modular viral clearance
  • Depth filtration
  • Regulatory agencies
  • FDA
  • PEI
  • Regulatory perspective
  • Continuous processing
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 4
July/August 2022
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Proceedings of the 2019 Viral Clearance Symposium, Session 8. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments and Actions
Glen Bolton
PDA Journal of Pharmaceutical Science and Technology Jul 2022, 76 (4) 362-367; DOI: 10.5731/pdajpst.2021.012684

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Proceedings of the 2019 Viral Clearance Symposium, Session 8. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments and Actions
Glen Bolton
PDA Journal of Pharmaceutical Science and Technology Jul 2022, 76 (4) 362-367; DOI: 10.5731/pdajpst.2021.012684
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  • Article
    • Abstract
    • Introduction
    • Session 1: Virus Clearance Strategy and Case Studies: Key Points, Outcomes, and Pending Questions
    • Session 2: New Modalities and Adsorptive Filters: Key Points, Outcomes, and Pending Questions
    • Session 3: Continuous Processing: Key Points, Outcomes, and Pending Questions
    • Session 4: Virus Clearance Strategy and Process Understanding: Key Points, Outcomes, and Pending Questions
    • Session 5: Virus Inactivation: Key Points, Outcomes, and Pending Questions
    • Session 6: Virus-Retentive Filtration: Key Points, Outcomes, and Pending Questions
    • Session 7: Cell Banks and Upstream Processes: Key Points, Outcomes, and Pending Questions
    • Other Items: Key Points, Outcomes, and Pending Questions
    • Conflict of Interest Declaration
    • References
  • References
  • Info & Metrics
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Cited By...

  • Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps
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More in this TOC Section

  • Proceedings of the 2023 Viral Clearance Symposium, Session 8: Cell Banks, Advanced Technologies (ATMPs, NGS)
  • Proceedings of the 2023 Viral Clearance Symposium, Session 3: 2023 VCS New Modalities in Chromatography and Adsorptive Filters
  • Proceedings of the 2023 Viral Clearance Symposium, Session 6: Viral Inactivation
Show more Conference Proceedings

Similar Articles

Keywords

  • Viral clearance
  • Viral Safety
  • Viral Clearance Symposium
  • Upstream processing
  • Downstream processing
  • Resin lifetime
  • Facility risk mitigation
  • Submission
  • Strategy
  • Next-generation sequencing
  • Modular viral clearance
  • Depth filtration
  • Regulatory agencies
  • FDA
  • PEI
  • Regulatory perspective
  • Continuous processing

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