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MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility

Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W Barone, Flora J Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy Springs
PDA Journal of Pharmaceutical Science and Technology October 2022, pdajpst.2021.012691; DOI: https://doi.org/10.5731/pdajpst.2021.012691
Andrea L. Koenigsberg
1 Center for Biomedical Innovation, Massachusetts Institute of Technology;
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Veronica Fowler
2 ECO Animal Health;
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Reuben Domike
3 Light Pharma, Cambridge, MA; Manufacturing Engineering at Brigham Young University;
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Audrey Brussel
4 PathoQuest;
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Paul W Barone
5 MIT;
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  • For correspondence: pbarone@mit.edu
Flora J Keumurian
5 MIT;
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  • For correspondence: florak@mit.edu
James Leung
5 MIT;
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Michael E. Wiebe
5 MIT;
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Michael T. Brewer
6 ThermoFisher;
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Shawn Chan
7 Gritstone;
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Nicolas Dumey
8 Sanofi;
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Anne Fournillier
8 Sanofi;
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Marcella Goodnight
9 AstraZeneca;
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Johanna Kindermann
10 Takeda;
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Richard Leavy
11 Amgen;
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Buyoung Lee
12 Genentech;
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Stefan Minning
13 Boehringer Ingelheim;
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Marie Murphy
14 Eli Lilly;
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Eric Myers
15 Pfizer;
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Armen Nahabedian
15 Pfizer;
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Kavita Nanda
16 Biogen;
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Sandi Parriott
17 BioMarin;
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GK Raju
18 LightPharma;
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Ciaran Scallan
19 Grittstone;
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Stephanie Schoch
20 CSL Behring;
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Joe Shiminsky
21 BMS;
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Bonnie Shum
12 Genentech;
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Sebastian Teitz
22 Asahi Kasei;
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Bernice Westrek
23 Merck and Co. Inc.
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Stacy Springs
5 MIT;
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  • For correspondence: ssprings@mit.edu
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Article Information

pdajpst.2021.012691
DOI 
https://doi.org/10.5731/pdajpst.2021.012691
PubMed 
36241212

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received September 13, 2021
  • Accepted September 15, 2022
  • Published online October 14, 2022.

Article Versions

  • You are currently viewing a previous version of this article (October 14, 2022 - 02:53).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2022, Parenteral Drug Association

Author Information

  1. Andrea L. Koenigsberg1,
  2. Veronica Fowler2,
  3. Reuben Domike3,
  4. Audrey Brussel4,
  5. Paul W Barone5 (pbarone{at}mit.edu),
  6. Flora J Keumurian5 (florak{at}mit.edu),
  7. James Leung5,
  8. Michael E. Wiebe5,
  9. Michael T. Brewer6,
  10. Shawn Chan7,
  11. Nicolas Dumey8,
  12. Anne Fournillier8,
  13. Marcella Goodnight9,
  14. Johanna Kindermann10,
  15. Richard Leavy11,
  16. Buyoung Lee12,
  17. Stefan Minning13,
  18. Marie Murphy14,
  19. Eric Myers15,
  20. Armen Nahabedian15,
  21. Kavita Nanda16,
  22. Sandi Parriott17,
  23. GK Raju18,
  24. Ciaran Scallan19,
  25. Stephanie Schoch20,
  26. Joe Shiminsky21,
  27. Bonnie Shum12,
  28. Sebastian Teitz22,
  29. Bernice Westrek23 and
  30. Stacy Springs5,24 (ssprings{at}mit.edu)
  1. 1 Center for Biomedical Innovation, Massachusetts Institute of Technology;
  2. 2 ECO Animal Health;
  3. 3 Light Pharma, Cambridge, MA; Manufacturing Engineering at Brigham Young University;
  4. 4 PathoQuest;
  5. 5 MIT;
  6. 6 ThermoFisher;
  7. 7 Gritstone;
  8. 8 Sanofi;
  9. 9 AstraZeneca;
  10. 10 Takeda;
  11. 11 Amgen;
  12. 12 Genentech;
  13. 13 Boehringer Ingelheim;
  14. 14 Eli Lilly;
  15. 15 Pfizer;
  16. 16 Biogen;
  17. 17 BioMarin;
  18. 18 LightPharma;
  19. 19 Grittstone;
  20. 20 CSL Behring;
  21. 21 BMS;
  22. 22 Asahi Kasei;
  23. 23 Merck and Co. Inc.
  1. ↵* Corresponding author; email: ssprings{at}mit.edu

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PDA Journal of Pharmaceutical Science and Technology: 79 (1)
PDA Journal of Pharmaceutical Science and Technology
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MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility
Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W Barone, Flora J Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek, Stacy Springs
PDA Journal of Pharmaceutical Science and Technology Oct 2022, pdajpst.2021.012691; DOI: 10.5731/pdajpst.2021.012691

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MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility
Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W Barone, Flora J Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek, Stacy Springs
PDA Journal of Pharmaceutical Science and Technology Oct 2022, pdajpst.2021.012691; DOI: 10.5731/pdajpst.2021.012691
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Keywords

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  • Virus contamination

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