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A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.
Though cell therapy is a recent innovation, with the first therapies approved by FDA in 2017, the use of human cells has been a standard of care for decades in hematology and oncology. A cell therapy can be derived from a variety of sources, including hematopoietic, skeletal muscle, neural, and mesenchymal stem cells (i.e., adult stem cells that differentiate into structures such as connective tissues, blood, lymphatics, bone, and cartilage). Given the urgency of ensuring good patient outcomes, it is essential to have a strategy in place for preventing contamination of source cells, as well as the resulting cell therapies.
eBook: Biologics and Sterile Drug Manufacturing, May 2020
When referring to this article, please cite it as F. Mirasol, “Detecting Contamination in Cell Therapies," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2020).