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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
  • Figures & Data
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References

  1. 1.
    Quality Guideline Q6B: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products; International Conference on Harmonisation: 1999. www.ich.org (accessed June 24, 2014).
  2. 2.
    Quality Guideline Q7A: Good Manufacturing Practice for Active Pharmaceutical Ingredients; International Conference on Harmonisation: 2005. www.ich.org (accessed June 24, 2014).
  3. 3.
    Technical Report No. 33: Evaluation, Validation, and Implementation of Alternative and Rapid Microbiological Methods; Parenteral Drug Association: 2013. www.pda.org (accessed June 24, 2014).
  4. 4.
    General Chapter <1111> Microbial Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. In USP 37/NF32; U.S. Pharmacopeia: 2014. www.usp.org
  5. 5.
    Annex 1. Manufacture of Sterile Medicinal Products; EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4; EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Brussels, 25 November 2008. www.ec.europa.eu
  6. 6.
    Annex 2. Manufacture of Biological active substances and Medicinal Products for Human Use; EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4; EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Brussels, 25 November 2008. www.ec.europa.eu
  7. 7.
    1. von Wintzingerode F.
    Biologics Drug Substance Production: Safety aspects of bioburden contaminations of non-sterile process intermediates. ECA, European Microbiology Conference, Copenhagen, April 24–25, 2013.
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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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