RT Journal Article SR Electronic T1 Risk Assessment Approach to Microbiological Controls of Cellular Therapies JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP pdajpst.2019.010546 DO 10.5731/pdajpst.2019.010546 A1 Cundell, Anthony M A1 Singer, Don A1 Ford, Irving A1 Drummond, Scott A1 Reber, Dona YR 2020 UL http://journal.pda.org/content/early/2020/01/15/pdajpst.2019.010546.abstract AB This technology review written by a small group of pharmaceutical microbiologists experienced in cellular therapies discusses a risk-based approach to microbiological contamination detection and control during gene and cell therapy production. Topics discussed include a brief overview of cellular therapies, a risk analysis related to donor selection, cell collection and infectious agent testing, cell transformation and expansion, packaging, storage and administration and cell therapy microbial contamination testing and release.