After years of intensive research and development, cell therapies are finally having their moment. In the past year, the FDA has approved two CAR-T cell (chimeric antigen receptor T-cell) therapies, with stem cell treatments in hot pursuit as they enter late-stage clinical trials. While regulatory body recognition is an important milestone for the field, great challenges in the long-term sustainability of the industry remain. By proving that cell therapy can be effective, researchers have won an early battle – but to win the war they must ensure that this therapy is effective and accessible for the tens of thousands of recipients in the years to come. Delivering these therapies at this scale in a reliable and affordable manner will require a paradigm shift in not only manufacturing but the subsequent supply chain and patient care that follow.
