TY - JOUR T1 - Risk Assessment Approach to Microbiological Controls of Cellular Therapies JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2019.010546 SP - pdajpst.2019.010546 AU - Anthony M Cundell AU - Don Singer AU - Irving Ford AU - Scott Drummond AU - Dona Reber Y1 - 2020/01/01 UR - http://journal.pda.org/content/early/2020/01/15/pdajpst.2019.010546.abstract N2 - 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. ER -