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History
- Published online April 9, 2020.
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- previous version (January 15, 2020 - 07:38).
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© PDA, Inc. 2020
Author Information
- Tony Cundell1,*,
- Scott Drummond2,
- Irving Ford3,
- Dona Reber4 and
- Donald Singer5
- members of the Pharmaceutical Microbiology Expert Discussion Group
- 1Microbiological Consulting LLC, Scarsdale, NY;
- 2Johnson & Johnson Companies, NB, NJ;
- 3Celgene Corporation, Summit, NJ;
- 4Pfizer, Collegeville, PA; and
- 5New Beginnings Microbiology, Phoenixville, PA
- ↵*Corresponding Author: Microbiological Consulting LLC, Scarsdale, NY. E-mail: tonycundell{at}gmail.com.
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- Article
- Abstract
- Introduction
- Overview of Contamination Control
- Microbial Contamination Control Strategy
- Input Materials
- Utilities
- Route of Administration Risk
- Manufacturing Facilities
- Manufacturing Process
- Cell Therapy Product Testing and Release
- Summary
- Conclusions
- Conflict of Interest Declaration
- Disclaimer
- Acknowledgments
- References
- Figures & Data
- References
- Info & Metrics
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Keywords
- Risk-based approach
- Microbial Contamination
- Cell therapies
- Donor selection
- Cell collection
- Cell transformation and expansion
- Bacterial endotoxin
- Sterility
- Mycoplasma
- Adventitious viruses
- Biological safety cabinets
- Restrictive access barrier systems
- Isolator systems
- In-process sterility testing
- Rapid microbial detection testing