PT  - JOURNAL ARTICLE
AU  - Anthony M Cundell
AU  - Don Singer
AU  - Irving Ford
AU  - Scott Drummond
AU  - Dona Reber
TI  - Risk Assessment Approach to Microbiological Controls of Cellular Therapies
AID  - 10.5731/pdajpst.2019.010546
DP  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.010546
4099  - http://journal.pda.org/content/early/2020/01/15/pdajpst.2019.010546.short
4100  - http://journal.pda.org/content/early/2020/01/15/pdajpst.2019.010546.full
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.