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EditorialBPOG Special Section

Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective

David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070
David Bain
Roles: Facilitator, BPOG
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  • For correspondence: david@biophorum.com
Diane Hardy
Roles: Chief Microbiologist, Regeneron
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Brian L. Bell
Roles: Senior Scientist, Bristol-Myers Squibb
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Ren-Yo Forng
Roles: Site Microbiologist, Astra Zeneca
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Michael Knight
Roles: Senior Manager, QC Microbiology, Genentech
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Anita Bawa
Roles: Director, QC, Bayer
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Stephanie Ramsey
Roles: Manager, Quality Systems, Baxter
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Christine Arbesser-Rastburg
Roles: Director Quality Operations/Microbiology, Baxter
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Mousumi Paul
Roles: Associate Director, Engineering, Merck
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Christopher Ton
Roles: Associate Director, Merck
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Fran Leira
Roles: Global MSAT/QC Head, Lonza
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Claudia Roman
Roles: Site Head, QC, Microbiology, GlaxoSmithKline
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Kim McFarland
Roles: Director, QC Microbiology, Alexion
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David Phillips
Roles: Senior Director, QC, Shire
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Jean Stuckey
Roles: Manager, QC, Microbiology/Lab Services, Patheon
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Christian Bauer
Roles: Head of Biotech Compliance and Projects, Sanofi
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Andres J. Calvo
Roles: Senior Scientist, AbbVie
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  • Article
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Article Information

vol. 69 no. 3 451-460
DOI 
https://doi.org/10.5731/pdajpst.2015.01070
PubMed 
26048751

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online June 4, 2015.

Copyright & Usage 
© PDA, Inc. 2015

Author Information

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PDA Journal of Pharmaceutical Science and Technology: 69 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 3
May/June 2015
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Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer, Andres J. Calvo
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: 10.5731/pdajpst.2015.01070

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Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer, Andres J. Calvo
PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: 10.5731/pdajpst.2015.01070
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Jump to section

  • Article
    • Introduction
    • Scope
    • Background
    • In-process Product Stream Monitoring and Testing
    • Inoculum Expansion Operations
    • Microbial Test Methods
    • Setting Bioburden Control Levels (Alert/Action)
    • Objectionable Organisms
    • Responding To Bioburden Excursions
    • Assessing Impact To Product Quality
    • Conclusion
    • Acknowledgements
    • Footnotes
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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