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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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Article Information

vol. 65 no. 6 715-729
DOI 
https://doi.org/10.5731/pdajpst.2011.00852
PubMed 
22294606

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online January 4, 2012.

Copyright & Usage 
© PDA, Inc. 2011

Author Information

  1. Robert D. Kiss
  1. Late Stage Cell Culture, Pharmaceutical Technical Development, Genentech, Inc. (a member of the Roche Group)
  1. 1 DNA Way, MS #96A, So. San Francisco, CA 94080. E-mail: kiss.robert{at}gene.com.
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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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Jump to section

  • 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
  • References
  • Info & Metrics
  • PDF

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Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium, Session 2.2: DSP Unit Operations–Purification Unit Operations
  • Proceedings of the 2017 Viral Clearance Symposium—
  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
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Plenary Session 7: Process Design Strategies for Prevention of Viral Contaminations

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

Paper

  • Massively Parallel Sequencing for the Detection of Adventitious Viruses
  • Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices
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