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Research ArticleConference Proceeding - Article

Conference Summary: Gaps, Lessons Learned, and Areas for Improvement

K. Brorson, G. Miesegaes, O. Tounekti, J. Skene and J. Blumel
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 83-89; DOI: https://doi.org/10.5731/pdajpst.2014.00968
K. Brorson
1Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD;
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G. Miesegaes
1Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD;
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O. Tounekti
2Health Canada, Ottawa, Ontario, Canada; and
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J. Skene
2Health Canada, Ottawa, Ontario, Canada; and
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J. Blumel
3Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany
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References

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    1. Miesegaes G.,
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    3. Willkommen H.,
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    Proceedings of the 2009 Viral Clearance Symposium. Dev. Biol. (Basel) 2010, 133, 3–101.
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    Characterization and purification of bacteriophages using chromatofocusing. J. Chromatogr., A 2008, 1207 (1), 110–121.
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    Understanding the mechanism of virus removal by Q sepharose fast flow chromatography during the purification of CHO-cell derived biotherapeutics. Biotechnol. Bioeng. 2009, 104 (2), 371–380.
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    PDA. Technical Report 47. Preparation of Virus Spikes Used for Virus Clearance Studies. Parenteral Drug Association: Bethesda, MD, 2010.
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    1. Miesegaes G.,
    2. Lute S.,
    3. Dement-Brown J.,
    4. Kaushal S.,
    5. Strauss D.,
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    A survey of quality attributes of virus spike preparations used in clearance studies. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 420–433.
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    A novel, Q-PCR based approach to measuring endogenous retroviral clearance by capture protein A chromatography. Biotechnol. Bioeng. 2009, 102 (5), 1438–1447.
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    ASTM. E2888-12: Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM International: West Conshohocken, PA, 2012.
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PDA Journal of Pharmaceutical Science and Technology: 68 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
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Conference Summary: Gaps, Lessons Learned, and Areas for Improvement
K. Brorson, G. Miesegaes, O. Tounekti, J. Skene, J. Blumel
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 83-89; DOI: 10.5731/pdajpst.2014.00968

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Conference Summary: Gaps, Lessons Learned, and Areas for Improvement
K. Brorson, G. Miesegaes, O. Tounekti, J. Skene, J. Blumel
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 83-89; DOI: 10.5731/pdajpst.2014.00968
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  • Article
    • Gaps and Action Items from 2009 Meeting
    • Gaps and Action Items with Follow-Up
    • Virus Isoelectric Points (pIs)
    • Characterization of Virus Preparations
    • CHO RVLP Assay Implementation
    • Ongoing or Unresolved Gaps and Action Items
    • Validation of Virus-Retentive Filtration
    • Development of Low-pH Inactivation Guidelines
    • Remaining Knowledge Gaps and Action Items
    • Conclusion of Follow-Up from the 2009 Meeting
    • Lessons Learned from the 2011 Meetings: Virus-Retentive Filtration
    • Gaps and Action Items Identified at the 2011 Symposium: Virus-Retentive Filtration
    • Lessons Learned from the 2011 Meetings: AEX
    • Gaps and Action Items Identified at the 2011 Symposium: AEX
    • Lessons Learned from the 2011 Meetings: Protein A Chromatography
    • Gaps and Action Items Identified at the 2011 Symposium: Protein A Chromatography
    • Lessons Learned from the 2011 Meetings: CEX
    • Gaps and Action Items Identified at the 2011 Symposium: CEX
    • Lessons Learned from the 2011 Meetings: Detergent Inactivation
    • Gaps and Action Items Identified at the 2011 Symposium: Detergent Inactivation
    • Lessons Learned from the 2011 Meetings: Emerging Unit Operations
    • Lessons Learned from the 2011 Meetings: Integration and Risk Management
    • Lessons Learned from the 2011 Meetings: Quality of Virus Spike Preparations
    • Gaps and Action Items Identified at the 2011 Symposium: Virus Spikes
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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Cited By...

  • Proceedings of the 2019 Viral Clearance Symposium, Session 6: Virus-Retentive Filtration
  • Session 2/3: Integrated Viral Clearance Strategy and Case Studies
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More in this TOC Section

  • Emerging Unit Operations (Session III): Hydroxyapatite, Mixed-Mode, and Adsorptive Membrane Chromatography; UV-C Inactivation; Chemical Precipitation
  • Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration
  • Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
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