Streamlining Cell Therapy Manufacture

T he cell therapy industry (CTI) is no longer a cottage industry; it is a distinct and sustainable component of the global healthcare sector (1). Today, CTI prospects are strong, with annual revenues exceeding US$1 billion/year, supported by improving investor sentiment and public support (1–3). The next phase of CTI growth — toward a multibillion-dollar global industry — will depend on the biomanufacturing community innovating to meet growing market demands and providing products at affordable costs to healthcare payers. Currently, the majority of cell therapy clinical trials are in phases 1 or 2 (4). However, as more CTI companies break the phase 3 frontier, clinical trials and regulatory requirements are becoming increasingly more predictable. This enables new companies to start out with a focus firmly on commercialization, using lessons learned from preceding trials to streamline their manufacturing processes and minimize the time to market. Here we propose a simple requirements-based framework for approaching three key, interrelated aspects of cell therapy bioprocessing that must be considered as these therapies translate from laboratory development to market launch: characterization, scale-up, and cost of goods (CoGs). In particular, we highlight the critical need to appreciate commercial implications of key bioprocessing decisions to maximize the efficiency and speed of cell therapy translation.