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
Diane Hardy
Roles: Chief Microbiologist, Regeneron
Brian L. Bell
Roles: Senior Scientist, Bristol-Myers Squibb
Ren-Yo Forng
Roles: Site Microbiologist, Astra Zeneca
Michael Knight
Roles: Senior Manager, QC Microbiology, Genentech
Anita Bawa
Roles: Director, QC, Bayer
Stephanie Ramsey
Roles: Manager, Quality Systems, Baxter
Christine Arbesser-Rastburg
Roles: Director Quality Operations/Microbiology, Baxter
Mousumi Paul
Roles: Associate Director, Engineering, Merck
Christopher Ton
Roles: Associate Director, Merck
Fran Leira
Roles: Global MSAT/QC Head, Lonza
Claudia Roman
Roles: Site Head, QC, Microbiology, GlaxoSmithKline
Kim McFarland
Roles: Director, QC Microbiology, Alexion
David Phillips
Roles: Senior Director, QC, Shire
Jean Stuckey
Roles: Manager, QC, Microbiology/Lab Services, Patheon
Christian Bauer
Roles: Head of Biotech Compliance and Projects, Sanofi
Andres J. Calvo
Roles: Senior Scientist, AbbVie

References
- 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.Quality Guideline Q7A: Good Manufacturing Practice for Active Pharmaceutical Ingredients; International Conference on Harmonisation: 2005. www.ich.org (accessed June 24, 2014).
- 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.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.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.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.
- von Wintzingerode F.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 3
May/June 2015
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
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
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
Related Articles
- No related articles found.