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
Scott Lute
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
Jessica Dement-Brown
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
Simran Kaushal
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
Daniel Strauss
2Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285
Dayue Chen
2Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285
Kurt Brorson
1Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and

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EMEA. Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products. Committee for Proprietary Medical Products, European Medicines Evaluation Agency, London, UK, 2006.
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ICH. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Q5A. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva Switzerland, 1999.
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PDA Technical Report 47: Preparation of Virus Spikes Used for Virus Clearance Studies. Bethesda, MD USA: Parenteral Drug Association, 2010.
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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
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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