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; James C. Leung; Nguyen Ly; Sheldon Mink; Stefan Minning; Jürgen Mülberg; Marie Murphy; Kerstin Nöske; Sandra Parriott; Bonnie Shum; Michael E. Wiebe; Stacy L. Springs

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, James C. Leung, Nguyen Ly, Sheldon Mink, Stefan Minning, Jürgen Mülberg, Marie Murphy, Kerstin Nöske, Sandra Parriott, Bonnie Shum, Michael E. Wiebe and Stacy L. Springs

PDA Journal of Pharmaceutical Science and Technology November 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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James C. Leung

1 MIT;

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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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Michael E. Wiebe

1 MIT;

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Stacy L. Springs

1 MIT;

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 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

PDA Journal of Pharmaceutical Science and Technology Nov 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

PDA Journal of Pharmaceutical Science and Technology Nov 2018, pdajpst.2018.008862; DOI: 10.5731/pdajpst.2018.008862

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Keywords

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

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Parenteral Drug Association, Inc.