Risk Assessment Approach to Microbiological Controls of Cell Therapies

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.

Keywords: Adventitious viruses; Bacterial endotoxin; Biological safety cabinets; Cell collection; Cell therapies; Cell transformation and expansion; Donor selection; In-process sterility testing; Isolator systems; Microbial contamination; Mycoplasma; Rapid microbial detection testing; Restrictive access barrier systems; Risk-based approach; Sterility.