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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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In This Issue

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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  • 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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  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Risk-Based Selection of Environmental Classifications for Biopharmaceutical Operations
  • Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective
  • Google Scholar

More in this TOC Section

BPOG Special Section

  • Introduction to BioPhorum Operations Group (BPOG) Special Section Editorials
  • Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test Runs
  • Changing the Performance Paradigm in Pharma/Biotech: Integrating Human Performance in Global Organizations
Show more BPOG Special Section

Editorial

  • Introduction to BioPhorum Operations Group (BPOG) Special Section Editorials
  • Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test Runs
  • Changing the Performance Paradigm in Pharma/Biotech: Integrating Human Performance in Global Organizations
Show more Editorial

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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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