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OtherCommentary

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, Phil Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mülberg, Marie Murphy, Kerstin Nöske, Sandra Parriott, Bonnie Shum and Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology October 2018, pdajpst.2018.008862; DOI: https://doi.org/10.5731/pdajpst.2018.008862
Paul W Barone
1 MIT;
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  • For correspondence: pbarone@mit.edu
Stephen Avgerinos
2 Pfizer;
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Rob Ballard
3 Biogen;
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Audrey Brussel
4 LFB;
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Phil Clark
5 Amgen;
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Chris Dowd
6 Genentech;
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Lionel Gerentes
7 Sanofi;
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Ian Hart
8 MedImmune;
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Flora J. Keumurian
1 MIT;
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  • For correspondence: florak@mit.edu
Johanna Kindermann
9 Shire;
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Nguyen Ly
10 Merck & Co.;
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Sheldon Mink
11 Regeneron;
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Stefan Minning
12 Boehringer Ingelheim;
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Jürgen Mülberg
13 Bristol-Myers Squibb;
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Marie Murphy
14 Eli Lilly;
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Kerstin Nöske
15 CSL Behring;
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Sandra Parriott
16 BioMarin
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Bonnie Shum
5 Amgen;
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Stacy L. Springs
1 MIT;
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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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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, Phil Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mülberg, Marie Murphy, Kerstin Nöske, Sandra Parriott, Bonnie Shum, Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology Oct 2018, pdajpst.2018.008862; DOI: 10.5731/pdajpst.2018.008862

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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, Phil Clark, Chris Dowd, Lionel Gerentes, Ian Hart, Flora J. Keumurian, Johanna Kindermann, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mülberg, Marie Murphy, Kerstin Nöske, Sandra Parriott, Bonnie Shum, Stacy L. Springs
PDA Journal of Pharmaceutical Science and Technology Oct 2018, pdajpst.2018.008862; DOI: 10.5731/pdajpst.2018.008862
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Cited By...

  • MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
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More in this TOC Section

  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies—A Multiple Company Collaboration—Post ICH Q5A(R2) Review
  • A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters
  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
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Keywords

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

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