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Article CommentaryCommentary

Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing

Paul W. Barone, Stephen Avgerinos, Rob Ballard, Audrey Brussel, Philip Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mullberg, Marie Murphy, Kerstin Nöske, Sandi Parriott, Bonnie Shum, Michael E. Wiebe and Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 191-203; DOI: https://doi.org/10.5731/pdajpst.2018.008862
Paul W. Barone
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
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  • For correspondence: pbarone@mit.edu
Stephen Avgerinos
2Pfizer, Andover, MA, USA;
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Rob Ballard
3Biogen, Durham, NC, USA;
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Audrey Brussel
4LFB, France;
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Philip Clark
5Amgen, Thousand Oaks, CA, USA;
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Chris Dowd
6Genentech, South San Francisco, CA, USA;
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Lionel Gerentes
7Sanofi, France;
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Ian Hart
8MedImmune, Gaithersburg, MD, USA;
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Flora J. Keumurian
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
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Johanna Kindermann
9Shire, Vienna, Austria;
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James C. Leung
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
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Nguyen Ly
10Merck & Co., Inc., Kenilworth, NJ, USA;
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Sheldon Mink
11Regeneron, Rensselaer, NY, USA;
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Stefan Minning
12Boehringer Ingelheim, Germany;
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Jürgen Mullberg
13Bristol-Myers Squibb, Devens, MA, USA;
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Marie Murphy
14Eli Lilly, Dublin, Ireland;
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Kerstin Nöske
15CSL Behring, Marburg, Germany; and
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Sandi Parriott
16BioMarin, San Rafael, CA, USA.
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Bonnie Shum
5Amgen, Thousand Oaks, CA, USA;
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Michael E. Wiebe
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
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Stacy L. Springs
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA, USA;
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PDA Journal of Pharmaceutical Science and Technology: 73 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
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Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing
Paul W. Barone, Stephen Avgerinos, Rob Ballard, Audrey Brussel, Philip Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mullberg, Marie Murphy, Kerstin Nöske, Sandi Parriott, Bonnie Shum, Michael E. Wiebe, Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 191-203; DOI: 10.5731/pdajpst.2018.008862
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  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
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Keywords

  • Functionally closed
  • Viral clearance
  • Facility segregation
  • Adventitious agent contamination
  • Physical segregation
  • Open ballroom

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Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing
Paul W. Barone, Stephen Avgerinos, Rob Ballard, Audrey Brussel, Philip Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mullberg, Marie Murphy, Kerstin Nöske, Sandi Parriott, Bonnie Shum, Michael E. Wiebe, Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 191-203; DOI: 10.5731/pdajpst.2018.008862

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