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 Anthony M Cundell
A1 Don Singer
A1 Irving Ford
A1 Scott Drummond
A1 Dona Reber
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.