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Risk Assessment Approach to Microbiological Controls of Cell Therapies

Tony Cundell1, Scott Drummond2, Irving Ford3

  • 1Microbiological Consulting LLC, Scarsdale, NY; tonycundell@gmail.com.

PDA Journal of Pharmaceutical Science and Technology
|January 17, 2020
PubMed

Keywords:
Adventitious virusesBacterial endotoxinBiological safety cabinetsCell collectionCell therapiesCell transformation and expansionDonor selectionIn-process sterility testingIsolator systemsMicrobial contaminationMycoplasmaRapid microbial detection testingRestrictive access barrier systemsRisk-based approachSterility

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