@article {Cundell229, author = {Tony Cundell and Scott Drummond and Irving Ford and Dona Reber and Donald Singer}, editor = {,}, title = {Risk Assessment Approach to Microbiological Controls of Cell Therapies}, volume = {74}, number = {2}, pages = {229--248}, year = {2020}, doi = {10.5731/pdajpst.2019.010546}, publisher = {Parenteral Drug Association (PDA)}, abstract = {This technology review, written by a small group of pharmaceutical microbiologists experienced in cell therapies, discussed a risk-based approach to microbiological contamination detection and control during gene and cell therapy production. Topics discussed include a brief overview of cell 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.}, issn = {1079-7440}, URL = {https://journal.pda.org/content/74/2/229}, eprint = {https://journal.pda.org/content/74/2/229.full.pdf}, journal = {PDA Journal of Pharmaceutical Science and Technology} }