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Over the past five years, there has been a jump in the number of cell therapy products commercially distributed by companies in the U.S., with eight cell therapy products receiving approval since 2009. Once such therapies are approved for the market, however, biopharmaceutical companies face new challenges as they develop the infrastructure to scale up the manufacture of larger quantities of cell products while maintaining high standards of quality control.
Companies advancing cell therapies at smaller scales already face multiple challenges in executing the safe, reliable, and consistent manufacture of a cell-based product. Cross-contamination due to the mixing of cell samples, as well as cell damage inflicted during freezing or other procedures, can jeopardize the purity and efficiency of the process. Improper labeling and record ...
