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OtherConference Proceeding

Practicing Safe Cell Culture: Applied Process Designs for Minimizing Virus Contamination Risk

Robert D. Kiss
PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 715-729; DOI: https://doi.org/10.5731/pdajpst.2011.00852
Robert D. Kiss
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Abstract

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1–3, 2010

Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA)

Genentech responded to a virus contamination in its biologics manufacturing facility by developing and implementing a series of barriers specifically designed to prevent recurrence of this significant and impactful event. The barriers included steps to inactivate or remove potential virus particles from the many raw materials used in cell culture processing. Additionally, analytical testing barriers provided protection of the downstream processing areas should a culture contamination occur, and robust virus clearance capability provided further assurance of virus safety should a low level contamination go undetected. This conference proceeding will review Genentech's approach, and lessons learned, in minimizing virus contamination risk in cell culture processes through multiple layers of targeted barriers designed to deliver biologics products with high success rates.

  • Virus contamination
  • Virus contamination risk
  • Virus safety
  • MVM
  • MMV
  • Minute mouse virus
  • Murine parvovirus
  • High temperature short time
  • HTST
  • Contaminations lessons learned
  • Contamination prevention
  • Raw material risks
  • © PDA, Inc. 2011
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 65 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 6
November/December 2011
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Practicing Safe Cell Culture: Applied Process Designs for Minimizing Virus Contamination Risk
Robert D. Kiss
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 715-729; DOI: 10.5731/pdajpst.2011.00852

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Practicing Safe Cell Culture: Applied Process Designs for Minimizing Virus Contamination Risk
Robert D. Kiss
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 715-729; DOI: 10.5731/pdajpst.2011.00852
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  • Article
    • Abstract
    • Introduction
    • Genentech's Virus Contamination Events
    • Assessing the Risk of Virus Contamination
    • Upstream Virus Barrier Technology Options and Assessment
    • Development and Implementation of Additional Cell Culture Process Virus Barriers
    • Downstream Process Virus Barriers (Clearance)
    • Overall Virus Barrier Program in Biologics Manufacturing
    • Lessons Learned and Conclusions
    • Acknowledgments
    • References
  • Figures & Data
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  • References
  • PDF

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Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.2: Upstream Mitigation, Part 2—Virus Barrier Filter and HTST
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
Show more Conference Proceeding

Plenary Session 7: Process Design Strategies for Prevention of Viral Contaminations

  • Application of Risk Assessments in the Design of the Overall Viral Control Strategy Used during the Manufacture and Testing of Live Virus Vaccines
  • Application of Quality by Design in the Control of Adventitious Viruses: Gaps in Current Processes in the Prevention of Virus Contaminants
  • Viral Safety of Plasma-derived Products
Show more Plenary Session 7: Process Design Strategies for Prevention of Viral Contaminations

Paper

  • Evolution of Approaches to Viral Safety Issues for Biological Products
  • Broadening Our Expectations for Viral Safety Risk Mitigation
  • Chlorine Dioxide Remediation of a Virus-Contaminated Manufacturing Facility
Show more Paper

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