1.
PDA J Pharm Sci Technol
; 74(2): 229-248, 2020.
Artigo
em Inglês
| MEDLINE
| ID: mdl-31941793
RESUMO
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.