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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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Article Information

vol. 76 no. 4 362-367
DOI 
https://doi.org/10.5731/pdajpst.2021.012684
PubMed 
34911826

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online August 1, 2022.

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  • previous version (December 15, 2021 - 09:06).
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© PDA, Inc. 2022

Author Information

  1. Glen Bolton*
  1. Amgen, 360 Binney Street, Cambridge MA 02142
  1. ↵*Corresponding Author: Amgen, 360 Binney Street, Cambridge MA 02142; Telephone: 617-444-5260; E-mail: gbolton{at}amgen.com
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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
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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

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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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