Risk Assessment Approach to Microbiological Controls of Cell Therapies

Tony Cundell; Scott Drummond; Irving Ford; Dona Reber; Donald Singer

doi:10.5731/pdajpst.2019.010546

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.

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