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Article CommentaryCommentary

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 L. Springs
PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691
Andrea L. Koenigsberg
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA;
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Veronica Fowler
2Oxford Nanopore Technologies, Oxford, United Kingdom;
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Reuben Domike
3Light Pharma, Cambridge, MA;
4Manufacturing Engineering at Brigham Young University, Provo, UT;
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Audrey Brussel
5PathoQuest, Paris, France;
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Paul W. Barone
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA;
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Flora J. Keumurian
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA;
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James Leung
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA;
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Michael E. Wiebe
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA;
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Michael T. Brewer
6ThermoFisher, Waltham, MA;
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Shawn Chan
7Gritstone, Emeryville, CA;
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Nicolas Dumey
8Sanofi, Marcy L'Étoile, France;
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Anne Fournillier
8Sanofi, Marcy L'Étoile, France;
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Marcella Goodnight
9AstraZeneca, Gaithersburg, MD;
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Johanna Kindermann
10Takeda, Vienna, Austria;
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Richard Leavy
11Amgen, Thousand Oaks, CA;
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Buyoung Lee
12Genentech, South San Francisco, CA;
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Stefan Minning
13Boehringer Ingelheim, Biberach, Germany;
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Marie Murphy
14Eli Lilly, Dublin, Ireland;
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Eric Myers
15Pfizer, Andover, MA;
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Armen Nahabedian
15Pfizer, Andover, MA;
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Kavita Nanda
16Biogen, Durham, NC;
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Sandi Parriott
17BioMarin, San Rafael, CA;
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GK Raju
3Light Pharma, Cambridge, MA;
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Ciaran Scallan
7Gritstone, Emeryville, CA;
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Stephanie Schoch
18CSL Behring, Marburg, Germany;
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Joe Shiminsky
19BMS, Devens, MA;
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Bonnie Shum
12Genentech, South San Francisco, CA;
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Sebastian Teitz
20Asahi Kasei, Cologne, Germany; and
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Bernice Westrek
21Merck & Co. Inc., Kenilworth, NJ
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Stacy L. Springs
1Center for Biomedical Innovation, Massachusetts Institute of Technology, Cambridge, MA;
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  • For correspondence: ssprings@mit.edu
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Abstract

Some members of MIT's Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) previously published content on the “Quality Risk Management in the Context of Viral Contamination”, which described tools, procedures, and methodologies for assessing and managing the risk of a potential virus contamination in cell culture processes. To address the growing industry interest in moving manufacturing toward open ballrooms with functionally closed systems and to demonstrate how the ideas of risk management can be leveraged to perform a risk assessment, CAACB conducted a case study exercise of these new manufacturing modalities. In the case study exercise, a cross-functional team composed of personnel from many of CAACB's industry membership collaboratively assessed the risks of viral cross-contamination between a human and non-human host cell system in an open manufacturing facility. This open manufacturing facility had no walls to provide architectural separation of two processes occurring simultaneously, specifically a recombinant protein perfusion cell culture process using the human cell line, HEK-293 (Process 1) and a downstream postviral filtration unit operation (Process 2) of a recombinant protein produced in CHO cells. This viral risk assessment focused on cross-contamination of the Process 2 filtration unit operation after the Process 1 perfusion bioreactor was contaminated with a virus that went undetected. The workflow for quality risk management that is recommended by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was followed, which included identifying and mapping the manufacturing process, defining the risk question, risk evaluation, and risk control. The case study includes a completed Failure Mode and Effects Analysis (FMEA) to provide descriptions of the specific risks and corresponding recommended risk reduction actions.

  • Risk assessment
  • Virus contamination
  • Cross contamination
  • Open ballroom

Footnotes

  • ↵i Current affiliation: CSL Behring

  • © PDA, Inc. 2023
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PDA Journal of Pharmaceutical Science and Technology: 77 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 2
March/April 2023
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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 L. Springs
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 115-132; 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 L. Springs
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 115-132; DOI: 10.5731/pdajpst.2021.012691

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