Abstract
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.
- Received July 30, 2019.
- Accepted December 10, 2019.
- Copyright © 2020, Parenteral Drug Association
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