Research ArticleTECHNOLOGY/APPLICATION

A Consensus Rating Method for Small Virus-Retentive Filters. I. Method Development

Scott Lute, William Riordan, Leonard F. Pease, De-Hao Tsai, Richard Levy, Mohammed Haque, Jerold Martin, Ichiro Moroe, Terry Sato, Michael Morgan, Mani Krishnan, Jennifer Campbell, Paul Genest, Sherri Dolan, Klaus Tarrach, Anika Meyer, The PDA Virus Filter Task Force, Michael R. Zachariah, Michael J. Tarlov, Mark Etzel and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology September 2008, 62 (5) 318-333;

Article Information

vol. 62 no. 5 318-333
PubMed 
19055228
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online September 1, 2008.
Copyright & Usage 
Copyright © Parenteral Drug Association. All rights reserved.

Author Information

  1. Scott Lute1,
  2. William Riordan2,
  3. Leonard F. Pease III3,
  4. De-Hao Tsai3,11,
  5. Richard Levy4,
  6. Mohammed Haque5,
  7. Jerold Martin5,
  8. Ichiro Moroe6,
  9. Terry Sato6,
  10. Michael Morgan6,
  11. Mani Krishnan7,
  12. Jennifer Campbell7,
  13. Paul Genest7,
  14. Sherri Dolan8,
  15. Klaus Tarrach9,
  16. Anika Meyer9,
  17. The PDA Virus Filter Task Force10,
  18. Michael R. Zachariah3,11,
  19. Michael J. Tarlov3,
  20. Mark Etzel2 and
  21. Kurt Brorson1,*
  1. 1Division of Monoclonal Antibodies, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), 10903 New Hampshire Blvd., Silver Spring, MD 20903
  2. 2Department of Chemical Engineering, University of Wisconsin, 1415 Engineering Dr., Madison, WI 53706
  3. 3Process Measurements Division, Chemical Sciences and Technology Laboratory, National Institute of Standards and Technology (NIST), 100 Bureau Dr., MS 8362, Gaithersburg, MD 20899
  4. 4Parenteral Drug Association (PDA) Global Headquarters, Bethesda Towers, 4350 East West Highway, Suite 200, Bethesda, MD 20814
  5. 5Pall Life Sciences, 2200 Northern Blvd., East Hills, NY 11548
  6. 6Asahi Kasei Medical America, Inc., 1600 Stewart Avenue, Westbury, NY, 11590
  7. 7Millipore Corporation, 290 Concord Road, Billerica, MA 01821
  8. 8Sartorius-Stedim North America, 131 Heartland Blvd., Edgewood, NY 11717
  9. 9Sartorius-Stedim Biotech Gmbh, Goettingen, Germany
  10. 10Hazel Aranha, Mark Bailey, Jean Bender, Jeff Carter, Qi Chen, Chris Dowd, Raj Jani, David Jen, Stanley Kidd, Richard Levy, Jerold Martin, Ted Meltzer, Kathryn Remington, Iris Rice, Cynthia Romero, Terry Sato, Maik Jornitz, Carol Marcus Sekura, Gail Sofer, Rachel Specht, Klaus Tarrach, Peter Wojciechowski, Mohammed Haque, Ichiro Moroe, Michael Morgan, Mani Krishnan, Jennifer Campbell, Paul Genest, Sherri Dolan, Kurt Brorson, Scott Lute
  11. 11Department of Chemistry and Biochemistry, University of Maryland, College Park, MD 20745
  1. * Corresponding Author: Kurt Brorson

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A Consensus Rating Method for Small Virus-Retentive Filters. I. Method Development
Scott Lute, William Riordan, Leonard F. Pease, De-Hao Tsai, Richard Levy, Mohammed Haque, Jerold Martin, Ichiro Moroe, Terry Sato, Michael Morgan, Mani Krishnan, Jennifer Campbell, Paul Genest, Sherri Dolan, Klaus Tarrach, Anika Meyer, The PDA Virus Filter Task Force, Michael R. Zachariah, Michael J. Tarlov, Mark Etzel, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Sep 2008, 62 (5) 318-333;
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