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Research ArticleResearch

A Survey of Quality Attributes of Virus Spike Preparations Used in Clearance Studies

George Miesegaes, Scott Lute, Jessica Dement-Brown, Simran Kaushal, Daniel Strauss, Dayue Chen and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 420-433; DOI: https://doi.org/10.5731/pdajpst.2012.00879
George Miesegaes
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
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  • For correspondence: george.miesegaes@fda.hhs.gov
Scott Lute
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
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Jessica Dement-Brown
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
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Simran Kaushal
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
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Daniel Strauss
2Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285
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Dayue Chen
2Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285
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Kurt Brorson
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
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References

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PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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A Survey of Quality Attributes of Virus Spike Preparations Used in Clearance Studies
George Miesegaes, Scott Lute, Jessica Dement-Brown, Simran Kaushal, Daniel Strauss, Dayue Chen, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 420-433; DOI: 10.5731/pdajpst.2012.00879

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A Survey of Quality Attributes of Virus Spike Preparations Used in Clearance Studies
George Miesegaes, Scott Lute, Jessica Dement-Brown, Simran Kaushal, Daniel Strauss, Dayue Chen, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 420-433; DOI: 10.5731/pdajpst.2012.00879
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  • Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies
  • Viral Clearance Integration (Session IV): General Trends, Bracketing, QbD, Virus Preparation Quality Attributes
  • Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Virus-Retentive Filtration
  • Conference Summary: Gaps, Lessons Learned, and Areas for Improvement
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