Sources of Variability in Manufacturing of Cell Therapeutics

Cellular immunotherapies are expected to greatly impact the future therapeutic landscape. Like other innovative and transformative fields, the industry is currently refining to keep pace with available technology. As a result, developers are employing more controls to minimize variability, and suppliers are addressing industry needs by addressing supply issues and characterizing material attributes with the careful awareness to the impact of the cost of the therapies. Process and analytical technologies are continuing to develop along with the components that are needed for them. Lay Summary Future efforts will focus in closing the gap in standardization of processes and materials. Creation of standards can mitigate risks associated with the variability intrinsic to cell therapy products. Increased characterization of processes, methods, products, and materials will also address variability within the cell therapy field.