“Full characterization is the cornerstone to successful development of any cell therapy and must span from early R&D through pilot production for trials to full-scale manufacture,” says McErlane. “Only in this way can a cell product be produced consistently and reproducibly. As a consequence, innovative companies such as Sistemic are working on novel methodologies, tool and products that can be used to sensitively and robustly characterize cell therapy products. In essence, sophisticated molecular characterization, and the ability to link this back to system biology, will be instrumental in delivering full characterization of the cell, the process and the product. As with any new technology it will be important that they are standardized for use in the industrial setting—something that Sistemic is developing in collaboration with its global partners.”