Early and vigilant planning can make a tremendous difference in the development of a cell therapeutic, especially when considering regulatory approval and commercial success of the product. In particular, the integration of high-quality raw materials and ancillary materials into the manufacturing process of pluripotent stem cell (PSC) therapies is crucial throughout the development process.
Unlike other cell therapies that are tailored for individual patients, PSC-derived products rely on a master cell bank that must last the entire lifetime of the product. Thus, raw material quality is extremely important from the beginning of the development process.
In this review, learn more about the strategies for gaining US FDA approval of allogeneic PSC therapies, including factors that can impact the cost, speed, safety and effectiveness of PSC-derived therapies.
This content was supplied by Thermo Fisher Scientific.manufacturing-pluripotent-cell-therapeutics-white-paper