Autologous cell therapies are at the forefront of the cell and gene therapy revolution. Here, cells from an individual patient are collected, processed ex vivo and then returned to the same patient.
The manufacturing of such personalized medicines poses complex new challenges. With small patient-scale batch sizes, centralized production using scale-up processes is no longer applicable and scale-out approaches become the norm. Today, the cost of production still represents a major hurdle on the path to market. New technologies are needed that enable robust and cost-efficient manufacturing, and yield replicable high quality medicines. Moreover, for autologous therapies, the patient stands at the beginning and end of the supply chain. Proximity of manufacturing to patients is key to reduce supply chain complexity.
While the therapeutic opportunities for patients are exciting, the stakes for patients and drug developers are high. Partnering in such a dynamic environment can improve the chances of success.