Clonality in Stem Cell Derived Therapies, a Journey From Process Development to Manufacturing

With a 30% growth rate and a projected $14 billion market by 2025, cell therapy, the use of cells as theactual therapy, is one of the most promising and increasingly valuable sectors in science. Using T cells, CAR-T cells and NK cells, often derived from hiPSC cells and using the latest in gene editing technologies, cell therapies represent possible treatments for a wide range of diseases including immuneoncology, neurodegenerative diseases, diabetes and heart failure. Emergent companies in this space have an eye on the future production of clinical treatments. Whatever the timescale, the question of when and how to implement practices that will be scalable to cGMP (current Good Manufacturing Practice) often arise.