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

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 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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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.

Author Information

George Miesegaes1,*,
Scott Lute1,
Jessica Dement-Brown1,
Simran Kaushal1,†,
Daniel Strauss2,
Dayue Chen2 and
Kurt Brorson1

¹Office of Biotechnology Products, CDER/FDA, 10903 New Hampshire Ave. Silver Spring, MD 20903 and
²Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285

↵* Correspondence author: Phone: (301) 796-2095. Fax: (301) 796-9817. E-mail: george.miesegaes{at}fda.hhs.gov

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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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