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OtherConference Proceeding

Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices

Amy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes and Rick Friedman
PDA Journal of Pharmaceutical Science and Technology November 2011, 65 (6) 563-567; DOI: https://doi.org/10.5731/pdajpst.2011.00820
Amy S. Rosenberg
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  • For correspondence: amy.rosenberg@fda.hhs.gov
Barry Cherney
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Kurt Brorson
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Kathleen Clouse
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Steven Kozlowski
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Patricia Hughes
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Rick Friedman
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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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Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices
Amy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes, Rick Friedman
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 563-567; DOI: 10.5731/pdajpst.2011.00820
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Plenary Session 2: Current Regulatory Approaches for Control of Viral Contamination

  • Current European Regulations for Control of Adventitious Virus Safety
  • Regulatory Approaches for Control of Viral Contamination of Vaccines
Show more Plenary Session 2: Current Regulatory Approaches for Control of Viral Contamination

Paper

  • Evaluation of a Single-Platform, Rapid, Nucleic Acid–Based Technology for Detection of Adventitious Contaminants of Cell Culture
  • Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections
  • Adventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine Circovirus
Show more Paper

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Risk Mitigation Strategies for Viral Contamination of Biotechnology Products: Consideration of Best Practices
Amy S. Rosenberg, Barry Cherney, Kurt Brorson, Kathleen Clouse, Steven Kozlowski, Patricia Hughes, Rick Friedman
PDA Journal of Pharmaceutical Science and Technology Nov 2011, 65 (6) 563-567; DOI: 10.5731/pdajpst.2011.00820

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