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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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Article Information

vol. 66 no. 5 420-433
DOI 
https://doi.org/10.5731/pdajpst.2012.00879
PubMed 
23035026

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 3, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. George Miesegaes1,*,
  2. Scott Lute1,
  3. Jessica Dement-Brown1,
  4. Simran Kaushal1,†,
  5. Daniel Strauss2,
  6. Dayue Chen2 and
  7. Kurt Brorson1
  1. 1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
  2. 2Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285
  1. ↵* Correspondence author: Phone: (301) 796-2095. Fax: (301) 796-9817. E-mail: george.miesegaes{at}fda.hhs.gov
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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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