PT  - JOURNAL ARTICLE
AU  - Tony Cundell
AU  - Scott Drummond
AU  - Irving Ford
AU  - Dona Reber
AU  - Donald Singer
ED  - ,
TI  - Risk Assessment Approach to Microbiological Controls of Cell Therapies
AID  - 10.5731/pdajpst.2019.010546
DP  - 2020 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 229--248
VI  - 74
IP  - 2
4099  - http://journal.pda.org/content/74/2/229.short
4100  - http://journal.pda.org/content/74/2/229.full
SO  - PDA J Pharm Sci Technol2020 Mar 01; 74
AB  - 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.