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Research ArticleTechnology/Application

Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies

Eva Gefroh, Houman Dehghani, Megan McClure, Lisa Connell-Crowley and Ganesh Vedantham
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 297-311; DOI: https://doi.org/10.5731/pdajpst.2014.00978
Eva Gefroh
Purification Process Development, Amgen Inc., Seattle, WA; and Biosafety Development, Amgen Inc., Seattle, WA
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  • For correspondence: gefrohe@amgen.com
Houman Dehghani
Purification Process Development, Amgen Inc., Seattle, WA; and Biosafety Development, Amgen Inc., Seattle, WA
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Megan McClure
Purification Process Development, Amgen Inc., Seattle, WA; and Biosafety Development, Amgen Inc., Seattle, WA
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Lisa Connell-Crowley
Purification Process Development, Amgen Inc., Seattle, WA; and Biosafety Development, Amgen Inc., Seattle, WA
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Ganesh Vedantham
Purification Process Development, Amgen Inc., Seattle, WA; and Biosafety Development, Amgen Inc., Seattle, WA
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Article Information

vol. 68 no. 3 297-311
DOI 
https://doi.org/10.5731/pdajpst.2014.00978
PubMed 
25188350

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 26, 2014.

Copyright & Usage 
© PDA, Inc. 2014

Author Information

  1. Eva Gefroh*,
  2. Houman Dehghani,
  3. Megan McClure,
  4. Lisa Connell-Crowley and
  5. Ganesh Vedantham
  1. Purification Process Development, Amgen Inc., Seattle, WA; and Biosafety Development, Amgen Inc., Seattle, WA
  1. ↵*Corresponding Author: Eva Gefroh, Mail Stop AW2/D2042, 1201 Amgen Court West, Seattle, WA 98119. Telephone: (206) 265-7439; email: gefrohe{at}amgen.com
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PDA Journal of Pharmaceutical Science and Technology: 68 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies
Eva Gefroh, Houman Dehghani, Megan McClure, Lisa Connell-Crowley, Ganesh Vedantham
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 297-311; DOI: 10.5731/pdajpst.2014.00978

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Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies
Eva Gefroh, Houman Dehghani, Megan McClure, Lisa Connell-Crowley, Ganesh Vedantham
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 297-311; DOI: 10.5731/pdajpst.2014.00978
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  • Article
    • Abstract
    • Introduction
    • Size Exclusion Mechanism of Virus Filter Retention
    • Selection of Model Viruses for Viral Clearance Studies
    • Datasets Comparing Clearance of Different Model Viruses
    • Conclusions and Recommendations
    • Declarations
    • Acknowledgements
    • References
  • Figures & Data
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  • Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration
  • Viral Clearance of Traditional Unit Operations: Virus-Retentive Filtration
  • Session 4: Overall Integrated Viral Clearance and Adventitious Agents Strategy
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Keywords

  • viral filtration
  • Parvovirus
  • MMV-only
  • Viral clearance

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