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;
G. Miesegaes
1Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Bethesda, MD;
O. Tounekti
2Health Canada, Ottawa, Ontario, Canada; and
J. Skene
2Health Canada, Ottawa, Ontario, Canada; and
J. Blumel
3Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany

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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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- Miesegaes G.,
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ASTM. E2888-12: Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM International: West Conshohocken, PA, 2012.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
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
Jump to section
- 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
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